Cention N PDF

Cention N
Scientific Documentation
Table of Contents
1. Introduction ...................................................................................................................... 3
1.1 Basic filling materials .............................................................................................................3
2. Cention N.......................................................................................................................... 7
2.1 Product overview ....................................................................................................................7
2.2 Resin/Monomer technology ...................................................................................................7
2.3 Filler technology .....................................................................................................................9
2.4 Polymerization Technology ................................................................................................ 13
2.5 Cention N: Clinical appearance .......................................................................................... 16
2.6 Comparison of basic filling materials ................................................................................ 18
2.7 Conclusion ........................................................................................................................... 18
3. Technical Data ............................................................................................................... 19
4. Materials Science Investigations / In Vitro ................................................................... 20

4.1 Depth of cure ........................................................................................................................ 20
4.2 Polymerization shrinkage ................................................................................................... 22
4.3 Ion release ............................................................................................................................ 28
4.4 Flexural and Compressive strength .................................................................................. 34
4.5 Linear Expansion ................................................................................................................. 38
4.6 Powder/Liquid mix ratio: User-tolerant material ............................................................... 39
4.7 Wear....................................................................................................................................... 41
4.8 Caries Inhibition ................................................................................................................... 43
4.9 Summary ............................................................................................................................... 50
5. Clinical Investigations with Cention N ......................................................................... 51
6. Biocompatibility ............................................................................................................. 55
6.1 Cytotoxicity ........................................................................................................................... 55
6.2 Mutagenicity ......................................................................................................................... 55
6.3 Irritation and sensitization .................................................................................................. 55
6.4 Conclusion ............................................................................................................................ 56
7. References ..................................................................................................................... 57
Scientific Documentation: Cention N Page 2 of 58

1. Introduction
Numerous direct filling materials are available to the modern dental practice – from amalgams
through to modern bulk fill composites. Amalgam materials were first introduced to western
dentistry in the 19th century,1 glass ionomer cements (GICs) were introduced around the 1970s,
composites became standard during the 1980s, resin modified glass ionomers2 and
compomers 3 were introduced in the 1990s and the current decade saw the launch of several
bulk-fill composites.
1.1 Basic filling materials

Amalgams and glass ionomer cements can be viewed as basic filling materials. Basic in the
sense that they are long-established, economical and simple to use. They are usually applied
in bulk without an adhesive, are self-curing and do not require complicated dental equipment.
Although the greater strides forward in direct filling materials have been made with dental
composites and their accompanying adhesives in recent decades; simple, basic restoratives
such as amalgam and glass ionomer cements remain popular.
1.1.1 Amalgam restoratives

Use and application: An amalgam is an alloy that contains mercury as one of its constituents.4
Standard dental amalgam is a combination of metals, containing approximately 50% mercury
in liquid form plus powdered silver, tin and copper in varying amounts. As mercury is liquid at
room temperature, it can be alloyed with solid metals. The process of “modern” amalgamation
in a clinic, consists of releasing mercury droplets from a sealed chamber within a capsule into
another chamber within that capsule which contains an alloy powder. The components are
then mixed together using an amalgamator device,4 in a process also known as trituration.
The mercury dissolves the surface of alloy particles and some new phases form which have
melting points well above any temperature that could normally occur in the mouth.
Amalgamation of the restorative continues in the mouth during application, as the material is
manipulated and condensed within the cavity - using firm pressure against the cavity walls or
matrix band. The goal of condensation is to attain the highest possible material density without
voids - establishing high strength and low creep. The reaction process decreases as the
amalgam sets i.e. hardens and increases in strength. Dental amalgam is sufficiently strong to
support moderate biting forces within the first hour. 4
Indications: Amalgam fillings are usually indicated for Class I and II restorations and tend to
be preferred for primary dentition or large posterior load-bearing fillings in permanent posterior
dentition where esthetic appearance is less important.
Clinical performance: The clinical success of an amalgam restoration depends on various
factors including: appropriate cavity preparation involving undercuts due to the non-retentive
nature of amalgam, condensation technique, anatomical characteristics and final finish.
Amalgam can also expand or contract, depending on how it has been manipulated. Severe
contraction can lead to microleakage, plaque accumulation and secondary caries and
excessive expansion can cause protrusion, put pressure on the pulp and cause postoperative
sensitivity. 4
In practice however, dental amalgam is a technique-insensitive material and its long term
clinical performance is exceptional. Anusavice reports that approximately 90% of amalgam
restorations are still functional after 10 years 4 and posits that this may be due to their tendency
to minimize marginal leakage, despite not adhering to tooth structure. This could be due to
corrosion products that form along the interface between the tooth and the restoration,
essentially sealing the interface and preventing leakage.

Clinical safety and acceptance: Although the use of amalgam became popular in the west
in the 19th century, its first use, was apparently recorded in Chinese literature in the year 659.5
Its long history and popularity however have not shielded it from controversy. The amalgam
debate surrounding the safety of mercury and any causal link with a variety of diseases, is one
of the oldest ongoing controversies in medicine.
The overwhelming body of scientific evidence demonstrates amalgam to be a safe restorative
material.5 Its safety in patients has been proven in countless studies and international
reports. 6-15 However due to wide media discussion of biocompatibility issues and mercury in
general, the suitability of this material is often questioned by patients as well as dentists.
Current European and international authority concerns, lie largely with the toxicological burden
on the environment due to mercury and less with patient-safety issues. A gradual phasing out
of amalgam however is largely supported and inevitable, thus alternative basic filling products
are long overdue.
Summary: Advantages and disadvantages of amalgam restorations
Advantages Disadvantages
Proven clinical longevity Mercury content: biocompatibility /environmental burden

Established and simple to use Unesthetic
Good mechanical properties Retentive preparation required
Inexpensive product Dentin discoloration
Table 1: Overview of principle advantages and disadvantages of amalgam filling materials
1.1.2 Glass Ionomer Cement restoratives

Use and application: Glass ionomers were invented in the late 60s, first described by Alan
Wilson and Brian Kent in the early 1970s 16 and introduced to the market soon after. They are
water-based, self-adhesive restorative materials in which the filler is a reactive glass called
fluoroaluminosilicate glass and the matrix is a polymer or copolymer of carboxylic acids.1 Glass
ionomers combine the technologies and chemistry of silicate and zinc polycarboxylate
materials so as to incorporate the desirable characteristics of both. The fluoroaluminosilicate
glass filler is ion-leachable but avoids the susceptibility to dissolution (a disadvantage in
silicates) by substituting phosphoric acid with the polymeric carboxylic acids of zinc
polycarboxylate materials.
Glass ionomer cements are supplied as two-part powder/liquid systems (often as capsules)
that are mixed (using an amalgamator) at the time of use.1 The setting reaction of the
powder/liquid mix into a conventional glass ionomer cement is an acid-base reaction. The
dissolved poly(acrylic) acid (in the liquid) reacts with the alkaline surface of the glass (in the
powder) in a “neutralisation reaction” producing water and a salt.
2 R-COOH + Ca(OH)2  R-COO- Ca2+ -OOC-R + 2 H2O
As shown schematically in Fig. 1, the acid first reacts with the calcium ions of the glass. The
2+
result of the ionic cross-linking of polycarboxylic acid by Ca is a workable cement that reaches
3+
its final stability in a second phase with cross-linking of Al .

Fig. 1: Schematic diagram of the neutralisation reaction mechanism of glass ionomer cements
An initial set is achieved within 3 to 4 minutes of mixing, but the ionic reaction continues for
at least 24 hours or more.1
Indications: Conventional glass ionomers as described above, are used as cements, liners,
orthodontic bracket adhesives, fissure sealants and as restorative materials. As the physical
and mechanical properties of glass ionomer cements are rather poor in terms of fracture
strength, toughness and wear,17 the principle restorative-indications encompass small
conservative lesions, non stress-bearing restorations in permanent teeth, temporary
restorations in permanent teeth, and when ART (atraumatic restoration technique) is used.
Clinical Performance:
Fluoride Ion Release and Uptake
Glass ionomers act as a long-term reservoir of fluoride ions. The fluoride is released into the
neighbouring enamel/dentin rendering it less susceptible to acid challenge. This fluoride ion
release is a result of the setting reaction and the ion exchange process in the cement. The
fluoride from the glass is replaced by carboxylates, phosphates (saliva) and water, thus if
properly formulated, cements should not lose their strength over time.
Adhesion
Glass ionomers are distinguished by their (albeit low) chemical bond to tooth structure,
achieved via an exchange of ions arising from both the tooth and restoration. Etching of the
enamel or dentin with phosphoric acid is not necessary. Despite their reasonable clinical
performance in terms of retention, glass ionomers are usually far less esthetic than composite
restoratives.18

Summary: Advantages and disadvantages of glass ionomer restorations
Advantages Disadvantages
Fluoride ion release Poor mechanical properties / Limited indication range

Non-expensive Unsuitable for stress bearing restorations
Chemical bond (albeit low) Basic esthetics
Table 2: Overview of principle advantages and disadvantages of glass ionomer filling materials
It should be noted that in recent years there have been considerable changes in the
formulations of glass ionomer cements, aimed at improving e.g. strength and/or esthestics.
These range from dual-curing versions to glass ionomer restoratives indicated only as a dentin
replacement material – that is then covered with a layer of composite restorative/varnish for
esthetic (roughness and shine) purposes. These changes have improved certain aspects of
traditional glass ionomer cements, but have necessarily made the products less “basic” and
added to the number of application steps in many cases.
1.1.3 Summary
The advent of new composite restorative materials, together with new adhesives has brought
enormous benefits - notably in terms of esthetics and strides towards minimally invasive
dentistry. They may however be perceived as expensive, time-consuming and technique-
sensitive. Their existence has not eliminated the need for or appropriateness of traditional
“basic” dental materials.
As described above, the economic, basic filling materials, amalgam and glass ionomers both
remain popular under particular dental circumstances. Amalgams offer unparalleled longevity
and strength but are coupled with poor esthetics and controversial ingredients. Glass ionomer
cements offer depot ion-release and undoubtedly improve on the esthetics of amalgams but
they provide far less strength and longevity. Both products clearly have certain drawbacks and
represent a clinical compromise in one respect or another.
Dentists have long sought after a real alternative to amalgam or glass ionomer cements – a
cost-effective, fluoride releasing product that is quick and easy to use without complicated
equipment and that offers both strength and good esthetics.
This scientific documentation introduces Cention N, a new basic filling material offering these
characteristics plus other advantages over both amalgams and glass ionomer cements.
Cention N is a basic, resin-based, self-curing powder/liquid restorative.

2. Cention N
2.1 Product overview
Cention N is an “alkasite” restorative. Alkasite refers to a new category of filling material,
which like compomer or ormocer materials is essentially a subgroup of the composite material
class. This new category utilizes an alkaline filler, capable of releasing acid-neutralizing ions.
Cention N is a tooth-coloured, basic filling material for direct restorations. It is self-curing with
optional additional light-curing. Cention N is available in the tooth shade A2. It is radiopaque,
and releases fluoride, calcium and hydroxide ions. As a dual-cured material it can be used as
a full volume (bulk) replacement material. Optional light curing is carried out with blue light in
the wavelength range of approximately 400 – 500 nm – thus all standard polymerization lights
can be used to cure the material.
Cention N consists of a separately packaged powder and liquid that are mixed by hand directly
before use. One scoop of powder is used per 1 drop of liquid, corresponding to a powder/liquid
weight ratio of 4.6 to 1. The liquid comprises dimethacrylates and initiators, whilst the powder
contains various glass fillers, initiators and pigments.
Fig. 2: Cention N basic filling material in Powder/Liquid format
Cention N is intended for restoring deciduous teeth and for permanent restorations of a Class
I, II or V nature. No etching with phosphoric acid is carried out when used without an adhesive.
Cention N may however be used with or without an adhesive. If without, then retentive
preparation (with undercuts) similar to that used with amalgam fillings is required and enamel
margins should not be bevelled. If it is used with an adhesive then the cavity is prepared
according to the modern principles of minimally invasive dentistry i.e. by preserving as much
natural tooth structure as possible and the corresponding instructions for use followed as
regards conditioning and application.
2.2 Resin/Monomer technology

Monomers together with initiators, catalysts and other additives, form the reactive part of a
resin-based restorative. Monomers compose the final matrix of the material and usually
comprise approximately 12 - 40% of the mass of the final material depending on the
characteristics desired. Dimethacrylate monomers are methacrylates with two polymerizable
methacrylate groups.
The organic, monomer part of Cention N is found in the Cention N Liquid. It consists of four
different dimethacrylates which represent 21.6% wt. of the final mixed material. A combination
of UDMA, DCP, an aromatic aliphatic-UDMA and PEG-400 DMA (see table 3), interconnects
(cross-links) during polymerization resulting in strong mechanical properties and good long-
term stability. Cention N does not contain Bis-GMA, HEMA or TEGDMA.

Fig. 3: Schematic representation of cross-linking
monomers resulting in a polymer network after curing
UDMA is the main component of the monomer matrix. It exhibits moderate viscosity and yields
strong mechanical properties. UDMA also has no hydroxyl side groups i.e. is hydrophobic and
exhibits low water absorption. DCP is a low-viscosity, difunctional, methacrylate monomer that
enables the hand-mixing of Cention N. Its cyclic aliphatic structure also ensures strong
mechanical properties. Aromatic aliphatic-UDMA, a partially aromatic urethane
dimethacrylate is a hydrophobic, high-viscosity cross-linker which combines the favourable
properties of aliphatic (low tendency to discolour) and aromatic (stiffness) diisocyanates.19
PEG-400 DMA, is a liquid monomer that enhances the flowability of Cention N. Its hydrophilic
character also promotes Cention N’s ability to wet tooth substrate (enamel and dentin) and
adapt to the smear layer.
Due to the sole use of cross-linking methacrylate monomers in combination with a stable,
efficient self-cure initiator, Cention N exhibits a high polymer network density and degree of
polymerization over the complete depth of the restoration. This is a good basis for long lasting
restorations.
Monomer Formula
UDMA
Urethane dimethacrylate
DCP
Tricyclodecan-dimethanol
dimethacrylate
Aromatic aliphatic-UDMA
Tetramethyl-xylylen-
diurethane dimethacrylate
PEG-400 DMA
Polyethylene glycol 400

dimethacrylate
Table 3: Structural formulae of monomers used in Cention N

2.3 Filler technology
Fillers are responsible for imparting restorative materials with the adequate strength to
withstand the stresses and strains of the oral cavity and to achieve acceptable clinical
longevity. The filler composition of Cention N is found in the Cention N Powder. The fillers of
Cention N were chosen to achieve strength but also to obtain the desired handling
characteristics of the mixed material. All the fillers therefore (except ytterbium trifluoride) are
surface-modified to ensure wettability by the liquid and incorporation into the polymer matrix.
The inorganic fillers comprise a barium aluminium silicate glass filler, ytterbium trifluoride, an
Isofiller (Tetric N-Ceram technology), a calcium barium aluminium fluorosilicate glass filler and
a calcium fluorosilicate (alkaline) glass filler, with a particle size of between 0.1 µm and 35 µm.
Barium aluminium silicate glass Ytterbium trifluoride
Fig. 4: Barium aluminium silicate glass Fig. 5: Ytterbium trifluoride
Isofiller Calcium barium aluminium fluorosilicate glass
Fig. 6: Isofiller: Shrinkage stress reliever Fig.7: Calcium barium aluminium fluorosilicate glass
Calcium fluorosilicate glass
Fig. 8: Calcium fluorosilicate glass

Filler Function
Barium aluminium silicate glass Strength
Ytterbium trifluoride Radiopacity
Isofiller Shrinkage stress relief

Calcium barium aluminium fluorosilicate glass Strength, fluoride release
Calcium fluoro silicate glass Ion release F-, OH-, Ca2+

Table 4: Overview of various fillers contained in Cention N and their respective function
2.3.1 Ion release

In its mixed state (powder + liquid) Cention N contains 78.4% wt. inorganic filler. The alkaline
glass accounts for 24.6% in weight of the final material and this releases substantial levels of
fluoride (F-) ions - comparable to those released by traditional glass ionomers. The alkaline
glass also releases hydroxide and calcium (OH- and Ca2+) ions which can further help prevent
demineralization of the tooth substrate.
The release of ions depends on the pH-value in the oral cavity. When the pH-value is low
(acidic), due for example to an active plaque biofilm i.e. highly active cariogenic bacteria,
Cention N releases a significantly larger amount of ions than when the pH-value is neutral.
Neutral pH Acidic pH
Fig. 9: Schematic representation of low (left) and high (right) levels of calcium, fluoride and hydroxide
ion release, depending on the pH in the oral cavity

Fluorapatite/Calcium fluoride
The benefits of fluoride in preventing enamel demineralisation, promoting remineralisation,
reducing plaque growth and consequently helping to prevent dental caries are well
documented 20. Demineralisation refers to the loss of minerals (largely calcium and phosphate
ions) from the tooth structure that occurs during acid attack/cariogenic challenge.
The inhibition of demineralisation/caries formation, by fluorides has been ascribed to the
reduced solubility of enamel due to the incorporation of fluoride ions into the crystal lattice of
enamel in the form of fluorapatite. In the presence of fluoride ions, the hydroxide ion (OH-) of
the hydroxyapatite can be exchanged by fluoride (F-), yielding fluorapatite.
Hydroxyapatite Fluorapatite
[Ca3(PO4)2]3·Ca(OH)2 ↔ [Ca3(PO4)2]3·Ca(F)2·
Current wisdom also ascribes the primary anti-caries activity of fluoride to a topical effect, i.e.
due to the formation of a calcium fluoride layer over the teeth that acts as a depot of ions e.g.
after topical fluoride varnish application. 21,22
Increased availability of these ions during a cariogenic challenge situation in vivo can promote
remineralisation and reduce the propensity for demineralisation. The positive cariostatic effects
of fluoride-containing (standard and resin-modified) glass ionomer cements in terms of the
inhibition of artificial caries adjacent to in vitro restorations has been detailed by Borges et al
using microhardness tests.23
Fluoride is also known to possess antibacterial properties – it reduces the cariogenic (lactic)
acid formation in plaque bacteria, such as Streptococcus mutans, by impairing bacterial
glucose uptake and glycolysis, 24,25 and thus can help reduce plaque growth and activity.
Hydroxide Ions
Whether a substance is acid or alkaline depends on the whether it donates or accepts
hydrogen ions respectively. When an acid is dissolved in water, positively charged hydrogen
cations outweigh negatively charged hydroxide ions. When an alkali (base) is dissolved in
water the reverse is true, because the base “soaks up” (neutralizes) the hydrogen ions.
The alkaline glass of Cention N releases hydroxide ions, creating conditions whereby excess
acidity due to cariogenic bacterial activity can be neutralized.

2.3.2 Shrinkage stress reliever
Due to the fact that Cention N is self-curing, the curing depth is theoretically unlimited. Cention
N is a full volume replacement material, designed to be applied quickly and conveniently in
bulk. In this context, it is important that the material exhibit low polymerization shrinkage and
low shrinkage force. Problems associated with polymerization shrinkage can include marginal
discoloration, marginal gaps, cracking and hypersensitivity.
Cention N includes a special patented filler (partially functionalized by silanes) which keeps
shrinkage stress to a minimum. This Isofiller, which is also used in Tetric N-Ceram Bulk Fill,
acts as a shrinkage stress reliever which minimizes shrinkage force, whereas the
organic/inorganic ratio as well as the monomer composition of the material, is responsible for
the low volumetric shrinkage.
When the material polymerises, either in self-cure modus or via additional light-curing, the
monomer chains located on the fillers together with the silanes begin a cross-linking process
and forces between the individual fillers come into play which (if the restorative has been
placed adhesively) place stress on the cavity walls. This stress is influenced by both volumetric
shrinkage and the modulus of elasticity of the material. A high modulus of elasticity denotes
inelasticity and a low modulus of elasticity denotes higher elasticity. Due to its low elastic
modulus (10 GPa) the shrinkage stress reliever within Cention N acts like a spring (expanding
slightly as the forces between the fillers grow during polymerization) amongst the standard
glass fillers which have a higher elastic modulus of 71 GPa. 26
Fig. 10: Shrinkage stress reliever used in Cention N
The silanes bonded to the filler particles improve the bond between the inorganic filler (glass
and quartz particles) and the monomer matrix as they are able to establish a chemical bond
between the glass surface and the matrix. Ultimately, the volumetric shrinkage and shrinkage
stress in Cention N are reduced during polymerization – allowing bulk increments to be placed.

2.3.3 Radiopacity
The ytterbium fluoride filler content also enables good visible clarity of the material on dental
x-rays, (280% Al). The pictures below show a Cention N filling (see blue box) in the clinical
setting and on x-ray.
Fig. 11a-b: Cention N filling in vivo and on x-ray. Photos courtesy of Dr Lukas Enggist, Clinic, Ivoclar
Vivadent 2016.
2.4 Polymerization Technology

2.4.1 Self-cure mechanism
Cention N is a self-curing material with optional light-curing. When the material is used in the
self-cure mode, the mixed restorative is applied in the cavity, condensed and sculpted and
then left to set for 4 minutes.
Self-curing systems are always made up of two components, which are kept separate to
prevent any premature reaction. The self-curing process is based on an initiator system
consisting of a copper salt, a peroxide and a thiocarbamide. The liquid part of Cention N
contains the hydroperoxide and the standard filler in the powder part of the product is coated
with the other initiator components. The copper salt accelerates the curing reaction.
This initiator system has certain advantages over conventional self-cure initiator systems such
as benzoyl peroxide/amine systems. The incorporation of a hydroperoxide that is more stable
than benzoyl peroxide (BPO) imparts the material with greater temperature-resistance i.e. it is
less sensitive to heat, which is an important factor regarding storage stability. The use of
thiocarbamide rather than amine also improves the colour stability of the product. It is generally
accepted that the colour stability of a material decreases with increasing amine content.

As the initiator system is separated by virtue of the delivery form, self-cure-polymerization can
only take place when the liquid and powder are mixed together. This self-cure mechanism,
involving radical formation and redox catalysis with Cu-ions is illustrated below.
Fig. 12: Self-cure mechanism of Cention N: Radical formation
Fig. 13: Mechanism of the redox catalysis with Cu-ions
2.4.2 Light-cure (dual-cure) mechanism

After mixing and placement of the restoration, the self-curing processes will initiate. However
for speed and convenience in finishing the restoration, it may be deemed advantageous to
utilize the optional light cure function.
Cention N contains the photoinitiator Ivocerin® and an acyl phosphine oxide initiator for optional
light-curing, with a dental polymerization unit. Ivocerin, a dibenzoyl germanium derivative 27,28
is an amine free, Norrish Type I initiator. Norrish Type I initiator refers to the fact that just one
component is responsible for radical formation. A Norrish Type II initiator such as
camphorquinone requires two components for light-induced radical formation to take place.
Like most standard initiators used in dental materials,

Ivocerin exhibits a yellow colour - the complementary colour
to blue light, with which all standard composites are
polymerized. Ivocerin however can be used in relatively small
quantities due to its high absorption coefficient/enhanced
reactivity, thus its properties can be utilized without
negatively affecting the optical properties of the restorative.
Any yellow colour largely disappears during curing.
Fig. 14: Photoinitiator Ivocerin

Polymerization takes place via free radical polymerization. Incoming photons from the curing
light are absorbed by the initiator Ivocerin, cleavage of a chemical bond within the initiator
molecule takes place and two radicals are formed, which subsequently react with the monomer
to produce a polymer network.
In general the darker and/or more opaque a material is, the shallower the depth of cure
because less light can reach the initiators within the material, however as Cention N is a dual-
cure material featuring self-curing and light-curing initiators, it can be applied as a full volume
replacement material i.e. in bulk. The light cure mechanism of the Norrish Type I initiator,
Ivocerin is depicted in the diagram below.
Fig.15: Light-cure mechanism of Cention N with Ivocerin
Only photons within a specific spectral range can be absorbed by various photoinitiators.
Ivocerin features a spectral range of approximately 370 to 460 nm, with a peak sensitivity of
around 410 nm. 26
Ivocerin bis(2, 4, 6-trimethylbenzoyl) phenylphosphine oxide

0.6
0.5
0.4
Absorption
0.3
0.2
0.1
0
350 370 390 410 430 450 470 490 510
nm
Fig. 16: Absorption spectra of Ivocerin and the acyl phosphine oxide photoinitiator. R&D Ivoclar Vivadent
2015.

As previously mentioned, Ivocerin is highly reactive and demonstrates intensive photon
absorption in the visible light spectrum. The quantum efficiency of dibenzoyldiethylgermane
was determined to be 0.85, far higher than other photoinitiators such as
champhorquinone/amine at 0.10. This leads to rapid curing and excellent bleaching behaviour,
aided by the fact that only small quantities are required. The light-cure system also utilizes an
acyl phosphine oxide photoinitiator. Compared to Ivocerin, bis(2, 4, 6-trimethylbenzoyl)
phenylphosphine oxide, has a considerably lower quantum efficiency of 0.59. 29 The absorption
maximum of the acyl phosphine oxide lies between 300 and 390 nm, and radical formation
occurs via light-induced breaking (photolysis) of the bond between the phosphorous group and
the carbonyl carbon. 29 Both Ivocerin and acyl phosphine oxide are included in the Cention N
powder.
Fig. 17: Chemical formula of acyl

phosphine oxide: Phenyl bis(2, 4, 6-
trimethylbenzoyl) phosphine oxide
When light-polymerized, the light is only able to sufficiently penetrate layers of up to 4mm in
thickness, therefore in cavities deeper than 4mm, the (self-cure) setting time of 4 minutes must
be observed.
2.4.3 Light insensitivity

The time available to mix, apply and contour a restorative material before it starts to polymerise
to the extent that manipulation becomes impossible of course also plays a very important role
in terms of user-friendliness. As Cention N is a dual-cure filling material it starts to slowly self-
cure as soon as the powder and liquid are mixed. The photoinitiator systems also react to the
blue light portion of the visible light spectrum – from e.g. daylight or operating lights. It is
therefore important that filling materials do not polymerise so quickly as to impact negatively
on the working time.
Cention N features a mixing time (on the pad) of approximately 45 to 60 seconds, a working
time (including the mixing time) to fill the cavity and model the filling of 2.5 minutes and an
overall setting time (including the mixing and working time) of 4 minutes.
2.5 Cention N: Clinical appearance

The esthetic superiority of Cention N over amalgam fillings, is a given and is clearly
demonstrated in the following pictures.
Fig 18a-c: From left to right: a: An inadequate amalgam filling in tooth 36. b: After excavation of amalgam
filling. c: Finished restoration. Photos courtesy of Dr Lukas Enggist, Clinic, Ivoclar Vivadent 2016.

Cention N is a relatively translucent material (transparency 11%) compared to other glass
ionomer based products, as shown in the comparison below.
Fig 19: Translucency comparison of Cention N and various GIC products: Fuji IX GP and Fuji II/GC and
Ketac Molar Easymix and Ketac Universal Handmix/3M Espe. R&D Ivoclar Vivadent 2015.
The material’s translucency however, creates no drawback regarding coverage of discoloured

dentin. The photos below compare Cention N with the glass ionomer cements Fuji IX GP and
Ketac Molar Easymix/3M Espe. The teeth used here are polychromatic prosthesis teeth filled
using retentive preparation over a bottom layer of IPS Empress Direct in the colour grey to
simulate dentin discoloration. Cention N (on the left below) makes the most esthetic impression
of the materials investigated and no grey shadow is visible.
Fig 20a-c: Prosthesis teeth filled with Cention N (left),Fuji IX GP/GC (A2) (middle) and Ketac Molar
Easymix/3M Espe (A3) (right) over a layer of IPS Empress Direct composite in grey. R&D Ivoclar
Vivadent 2016.
In the clinical setting below it can also be seen that Cention N blends more naturally with the
surrounding tooth structure than the glass ionomer filling material.
Fig. 21a-b: a: Left: Chalky-white opaque glass ionomer restoration. b: Right: More translucent, natural-
looking Cention N restoration in tooth in centre of picture. Photos (21a: Internet) and (21b: Dr Lukas
Enggist, Clinic, Ivoclar Vivadent, 2016

2.6 Comparison of basic filling materials
The following table compares various product characteristics relevant to the esthetics, material
durability, and handling of standard amalgams, GICs and Cention N.
Amalgam GIC Cention N
Preparation Capsule Hand Mix / Capsule Hand Mix

Transparency (%) 0 3-4 11
Flexural strength (MPa) n/a 22-36 110 (SC)
Modulus of elasticity (GPa) 20-35 15-21 13 (SC)
Compressive strength (MPa) 300 190-250 300 (SC)
Radiopacity (% Al) >1000 170-260 280
Table 5: Technical comparison of standard basic filling materials with Cention N. R&D Ivoclar
Vivadent (SC = Self-cured).
Cention N offers greater mechanical strength than glass ionomers, good handling and better
esthetics than both amalgam and glass ionomers.
2.7 Conclusion
Although Cention N is similar to a standard amalgam or glass ionomer restoration in terms of
bulk placement, possible use without an adhesive and self-curing properties; it also has a
number of advantages over these materials. The principle differences between the products
are shown in the table below.
Amalgam GIC Cention N
Durable ✓ ✗ ✓
Mechanical strength ✓ ✗ ✓
Permanent & deciduous restorations ✓ ✗ ✓
Esthetic / Life-like appearance ✗ - ✓
Ca2+ und F- ion releasing ✗ ✓ ✓
OH- ion releasing ✗ ✗ ✓
Optional light cure ✗ ✗/✓ ✓
Table 6: Property comparison of amalgam, glass ionomer (GIC) and Cention N basic filling materials
The alkasite Cention N thus redefines the basic filling, combining bulk placement, ion release,
and durability in a dual-curing, esthetic product - satisfying the demands of both dentists and
patients.

3. Technical Data
Cention N Dual-curing restorative material
Function Substance/Component Weight (%)
Powder Liquid
Calcium fluorosilicate glass 25 - 35
Ba-Al silicate glass 20 - 30
Filler Ca-Ba-Al fluorosilicate glass 10 - 20 ---
Ytterbium trifluoride 5 - 10
Isofiller (Copolymer) 15 - 25
Monomer Dimethacrylate --- 95 - 97
Additive Additive --- 1-2
Initiator Initiator <1 2-3
Stabiliser Stabiliser --- <1
Pigment Pigment < 0.1 ---
Characteristics1 Unit Specification*
Flexural strength2 MPa ≥ 100
Working time (23 °C) s ≥ 90
Setting time (37 °C) min ≤5
Water sorption (7 days) µg/mm3 ≤ 40
Solubility (7 days) µg/mm3 ≤ 7.5
Radiopacity
% ≥ 200
(Relative equivalence to ≥ 1mm Al)
*The product meets the performance criteria defined in EN ISO 4049:2009 (Type 1, Class 3)
1
Chemical, Mechanical, Physical properties
2
Higher than standard requires

4. Materials Science Investigations / In Vitro
4.1 Depth of cure
ISO 4049: Depth of cure

The international standard ISO 4049 for polymer based restorative materials suggests
measuring depth of cure via preparing cylindrical specimens 6 mm long and 4 mm wide, or if
a depth of cure greater than 3 mm is claimed, the length should be at least 2 mm longer than
twice the claimed depth of cure. After curing according to the manufacturer’s instructions, the
material is removed from its mould, the inhibition layer and other uncured material is scraped
away and the height of the remaining material is measured. This value divided by 2 is
considered to be the depth of cure. This method does not account for post-irradiation
polymerization.
Vickers/Knoop hardness: Depth of cure

Other methods for establishing the degree and depth of cure include conducting Vickers
hardness and Knoop hardness profiles of the cured material. These can be conducted some
time after curing, allowing for post-irradiation polymerization and can be carried out equally on
light-cured or self-cured materials.
The Vickers hardness test utilises a diamond pyramid shaped indenter that is ground in the
form of a squared pyramid with an angle of 136° between faces and the depth of indentation
is about 1/7 of the resulting impression’s diagonal length.
The Knoop hardness test utilises a diamond elongated pyramid shaped indenter that is ground
to an elongated pyramidal form that produces a diamond shaped indentation with a depth of
indentation of about 1/30 of the indentation’s length.
The advantage of Vickers hardness over Knoop hardness testing is that with Vickers
indentations, two axes rather than one can be used for analysis, resulting in more reliable data.
Fig. 22: Schematic representation of Vickers (left) and Knoop (right) hardness test indentations with
corresponding axes for analysis
Cured specimens are usually prepared in cylindrical moulds and the hardness at the top and
bottom of the cylinder is measured to obtain a simple single hardness measure. For a hardness
profile throughout the material, cured specimens are cut vertically into two pieces. The cut
surfaces are polished and the hardness is determined at intervals from the top to the bottom.
Hardness is often expressed as a percentage of the surface hardness which is considered
100%.30 Experience has shown that the simple hardness measures (top and bottom)
correspond well to the more thorough hardness profile measurements.31 According to research
carried out by Professor David Watts of the University of Manchester, UK, an acceptable curing
depth is achieved, if the bottom hardness corresponds to at least 80% of the surface
hardness.32

With purely light-cured resins, measurements have shown that the degree of cure decreases
continuously in areas deeper than approximately 0.5 mm. The degree of cure is highest at a
depth of 0.55 mm, because of the uppermost inhibition layer. From this layer downwards, the
light intensity entering the material decreases steadily as filler particles scatter light and colour
pigments absorb it. A post-light-curing reaction with remaining radicals tends to occur within
24 hours after initial polymerization and this is also accompanied by a decrease in the yellowish
tinge if camphorquinone is used as a photoinitiator. Thus to determine depth of cure, test
samples are usually stored for 24 hours before measurements are made. With dual-cured
resins a reduction in hardness is less likely to be seen at constantly increasing depths, due to
self-curing processes occurring simultaneously throughout the material.
An internal investigation using Vickers hardness profile testing, confirmed the adequate depth
of cure and equivalence of Cention N when used in self-cure and dual-cure mode.
4.1.2 Comparison of Vickers hardness in Self-Cure and Dual-Cure mode

Vickers hardness profile testing of Cention N in self-curing and dual-curing mode
Objective: To establish equivalence or any substantial differences in the material hardness of

Cention N when used in self-cure or dual cure mode.
Methods: Specimens of Cention N were prepared (2 per curing mode) with a diameter of 6
mm and a height of 8 mm. The light-cured (dual-cured) specimens were cured as specified in
the instructions for use i.e. for 20 seconds using Bluephase N (High Power). Self-curing took
place over an hour at 37°C in an oven. After polymerization, all samples were stored at 37°C
for 24 hours, embedded in resin (Stycast) and then stored for a further 24 hours at room
temperature. The averages of the Vickers hardness profile values for the two samples per
curing mode were calculated and the bottom/top hardness percentages were also calculated
at 0.5 mm intervals.
Results:
Cention N dual-cured: 20 s Bluephase N Cention N self-cured: 1 hour in oven at
(High Power) 37°C
mm Mean Vickers % of Surface Mean Vickers % of Surface
Hardness Hardness Hardness Hardness
0.5 650.0 100.00% 619.0 100.00%
1.0 680.7 104.71% 584.2 94.37%
1.5 658.6 101.32% 633.4 102.32%
2.0 689.8 106.11% 631.9 102.07%
2.5 697.3 107.28% 643.8 103.99%
3.0 690.9 106.29% 650.2 105.02%
3.5 686.1 105.55% 596.2 96.31%
4.0 672.2 103.41% 619.6 100.10%
4.5 677.8 104.28% 609.0 98.37%
5.0 669.5 102.99% 585.9 94.65%
5.5 657.6 101.17% 616.2 99.54%
6.0 650.1 100.02% 634.3 102.46%
6.5 679.5 104.53% 626.3 101.17%
7.0 698.9 107.52% 627.5 101.36%
Table 7: Mean Vickers hardness profile values and as a percentage of the surface hardness in samples
of self-cured and dual-cured Cention N. R&D Ivoclar Vivadent 2016.

The mean Vickers hardness profile of Cention N in self-cure mode is comparable to that of
Cention N in dual-cure mode. The hardness values however do tend to be slightly higher in
the dual-cure mode. As Cention N is hand-mixed some small individual air bubbles are
unavoidable and these can also affect the values at individual measuring points.
It is generally accepted that an adequate depth of cure has been achieved if the bottom
hardness corresponds to at least 80% of the surface hardness.32 The diagram below depicts
the bottom/top values (percentage of surface hardness) for each point along the length of the
Cention N specimen in both dual-cure (DC) and self-cure modes (SC).
Fig 23: Vickers hardness (VH) profile values as a percentage of the surface hardness in samples of self-
cured (SC) and dual-cured (DC) Cention N. R&D Ivoclar Vivadent 2016.
Conclusions: Importantly, it can be seen that the DC and SC values are comparable; with the
DC values (involving light curing), tending to be slightly higher. Notably all values at all depths,
are all well above the 80% level discussed by Watts.
4.2 Polymerization shrinkage

Minimizing shrinkage stress is particularly important in a full volume replacement material that
is applied in bulk. Cention N therefore contains a shrinkage stress reliever (described in section
2.3.2) with a low modulus of elasticity. It acts like a microscopic spring, attenuating the forces
generated during shrinkage. Reduced polymerization shrinkage should translate as lower
volumetric shrinkage, improved marginal integrity and reduced shrinkage stress force over the
restorative surface/on the adhesive bond (if applied).

4.2.1 Volumetric shrinkage and shrinkage force
The effect of the inclusion of the shrinkage stress reliever (patented polymeric Isofiller) as
described in section 2.3.2. was measured in terms of volumetric shrinkage and shrinkage
force. Volumetric shrinkage was tested according to the standard ISO 17304:2013
(Archimedes principle) for polymer-based restorative materials and shrinkage force was
measured using a Watts machine. With the self-cure initiators included, the restorative starts
to cure and shrink immediately, such that determining a start-point for the measurements is
impossible. A batch of Cention N was therefore produced without any self-cure initiators in
order to facilitate reliable and reproducible shrinkage measurements. Polymerization was
carried out via light-curing only and shrinkage was measured in Cention N with the shrinkage
stress reliever and without.
Fig. 24: Volumetric shrinkage in Cention N formula (without self-cure initiators) with and without the
Isofiller/shrinkage stress reliever. R&D Ivoclar Vivadent 2015.
Fig. 25: Shrinkage stress in Cention N formula (without self-cure initiators) with and without the
Isofiller/shrinkage stress reliever. R&D Ivoclar Vivadent 2015.
Volumetric shrinkage and shrinkage stress are both low in Cention N and the positive effect of
the shrinkage stress reliever can clearly be seen in both values.
4.2.2 Marginal integrity
Ultra-morphological study of the interface: Dentin/Cention N as a function of saliva
contamination and the usage of an adhesive system.
Manuela Lopes, Assistant Professor, Faculty of dental medicine, University of Lisbon, Portugal. April 2015
Objective: To evaluate the performance of Cention N with and without an adhesive system,
in order to assess the risk of post-operative sensitivity. The parameters assessed were:
gaps/nanoleakage between dentin and the filling material/adhesive system and the occlusion
of dentinal tubules with smear layer or polymers. Both parameters were assessed with or
without saliva contamination.
Methods: 18 recently extracted human third molars were used. They were stored in a solution
of 0.5% chloramine at 4º C and used within 1 month after extraction. Standardized Class II
cavities (n=36) were prepared on the mesial and distal surfaces of the teeth by two different
operators in the Preclinical Laboratory of IVAG. Each molar received two Cention N fillings A:
(on a dry surface) and B: (on a wet surface i.e. contaminated with saliva). Saliva having been
collected from 5-10 people and pooled. All fillings were dual-cured.
The teeth were randomly and equally assigned into 3 groups of six teeth i.e. 12 fillings. Each
group involved 2 subgroups each i.e. A: Dry (n=6 fillings) or B: Wet n=6 fillings). The table
below illustrates the study set-up with n representing the number of fillings.
Cention N Restorations
(n=36)
Group 1 Group 2 Group 3

Retentive preparation Adhese Universal Adhese Universal
(No adhesive) (Self-etch) (Etch & Rinse)
(n = 12) (n = 12) (n = 12)
Subgroup A Subgroup B Subgroup A Subgroup B Subgroup A Subgroup B

Dry surface Wet surface Dry surface Wet surface Dry surface Wet surface
(n=6) (n=6) (n=6) (n=6) (n=6) (n=6)
Table 8: Study distribution of Cention N fillings according to adhesive group and wet or dry substrate
All specimens were stored in distilled water at 37°C for 24 hours. The restored teeth were
cross-sectioned in two identical halves in order to expose a flat interface of dentin and
Cention N filling material. The samples underwent ultra-morphological examination via
scanning electron microscopy.
Results: Gap Formation/Nanoleakage and Dentin Hybridization: Leakage differed,

depending on the mode of application of Adhese Universal and as a function of saliva
contamination.
Group 1 / No adhesive: On a dry surface, gaps were generally observed between Cention N
and dentin (see Figs. 26a and 27a). Some resin-infiltrated smear plugs were observed but
largely there were few signs of resin-interdiffusion. Micromechanical locking was more limited
to surface roughness induced by diamond burs curing cavity preparation.
Group 2 / Adhese Universal SE: On a dry surface, the interface between Cention N and
dentin was largely sealed as an acid-resistant, resin-dentin interdiffusion zone when applied
with Adhese Universal in self-etch mode (see Figs. 26b and 27b). A consistent hybrid layer of
0.5-0.6 µm thickness was demonstrated. The least extensive silver nitrate penetration with in
the hybrid layer was found in this group.

On a wet surface, the interface between Cention N and dentin was also mostly sealed as an
acid-resistant, resin-dentin interdiffusion zone however, nanoleakage was demonstrated within
the hybrid layer and adhesive layer.
Group 3 / Adhese Universal TE: On a dry surface, generally all the interface restored with
Cention N and Adhese Universal in total-etch mode was sealed as an acid-resistant, resin-
dentin interdiffusion zone (see Figs. 26c and 27c). With this method the hybrid layer was well
defined and typically 3.5 - 5.0 µm. Resin tags were observed.
On a wet surface, the interface between Cention N and dentin was also mostly sealed as an
acid-resistant, resin-dentin interdiffusion zone however, in some localized areas a 1 µm gap
developed between the restoration and the top of the interdiffusion zone. The hybrid layer was
also well-defined and typically 3.5-5.0 µm.
The back-scattered FEG-SEM (Field Emission Gun – Scanning Electron Microscope) micrographs
below, compare the interface between dentin and Cention N, under dry conditions, when no
adhesive is used and when Adhese Universal in self-etch and total-etch mode is used.
SEMs (50x): Gap Formation
Restoration Restoration Restoration
Dentin
Dentin
Dentin
Fig. 26a-c: SEM Micrographs 50x: a: No adhesive – slight gap visible. b. Adhese Universal (SE) – sealed
interface. c. Adhese Universal (TE) – sealed interface. Lopes, University of Lisbon, Portugal. April 2015.
SEMs (1000x): Gap Formation & Dentin Hybridization
Restoration
Restoration Restoration
Dentin
Dentin Dentin
Fig 27a-c: SEM Micrographs 1000x: a. No adhesive – slight gap visible. b. Adhese Universal (SE) –
sealed interface/hybrid layer/resin tags. c. Adhese Universal (TE) – sealed interface/hybrid layer/resin
tags. Lopes, University of Lisbon, Portugal. April 2015.
Conclusions: Cention N applied with retentive preparation and no adhesive, exhibited an

acceptable gap between dentin and the restorative material of about 20 µm on average. The
gap size had a uniform distribution with maximum gap sizes of approximately 40 µm. In this
group, the dentinal tubules were covered with smear layer, which was about 2 µm thick. The
smear layer that occluded the tubules serves as a barrier to prevent the fluid shift inside the
tubules. Based on these observations, it is likely that the risk of postoperative hypersensitivity
with Cention N (applied without adhesive) is similar to amalgam restorations.
Adhese Universal showed good sealing of the dentinal surface with both tooth conditioning
techniques (Etch&Rinse and Self-Etch). Nanoleakage was low with both techniques under dry
conditions.

Microleakage of Cention N compared to dental amalgam. Final Report.
John Burgess, Assistant Dean, School of dentistry, University of Alabama, Birmingham, USA. May 2015
Background: Microleakage refers to the leakage of tiny amounts of fluids and debris in the
space between a dental restoration (cement or adhesive) and the tooth (cavity wall) at the
surface. Linked to poorly fitting restorations, it may or may not be clinically obvious but has
been linked to secondary caries, marginal discoloration and hypersensitivity. 33
Objective: To evaluate microleakage and dye penetration in human enamel and dentin
margins in cavities filled with Cention N (with or without adhesive) and amalgam.
Methods: Three standardized Class V cavities using a stamp were prepared around extracted
human molars. The buccal, lingual and mesial surfaces were used, placing the occlusal margin
in the enamel and the apical margin in the dentin/cementum. Preparations were hand prepared
to 1.5mm in depth and each tooth then received 3 different fillings: Cention N (plus Adhese
Universal in Total-Etch mode), Cention N without adhesive and Valiant an Ivoclar Vivadent
amalgam. Restorations were polished and margins were evaluated to exclude the existence
of “flash” i.e. excess product, due to overfilling. Teeth were sealed with two coats of acid-
resistant varnish leaving a window including the restoration and 2mm of tooth structure
uncoated surrounding the restoration. Teeth were then stored in an incubator in distilled water
at 37°C for 24 hours. Samples were then immersed in 5 wt% fuchsine solution for 24 hours
and sectioned longitudinally. One of the halves was sectioned a second time to intersect the
preparation on the mesial surface. Sections were investigated using a digital microscope at
30x magnification and dye penetration was quantitatively evaluated by measuring the distance
of the dye penetration from the external surface. The length of the dye penetration and total
length of the preparation were recorded.
Fig. 28: Comparison of fuchsine dye penetration in Class V Cention N fillings (with and without adhesive)
and in amalgam (without adhesive). Burgess, University of Alabama, USA, May 2015.
Results: The pictures above show little dye penetration when Cention N is applied with
adhesive. As would be expected, dye penetration is far more visible when no adhesive is used
and it can be seen that this is comparable with amalgam (no adhesive). Average dye
penetration was also measured using digital analysis software with a Keyence digital
microscope VHX 600 series. The results corroborate what is seen above.

Fig. 29: Comparison of mean dye penetration at enamel and cementum margin for Cention N applied
with and without Adhese Universal (Bond) and amalgam. Burgess, University of Alabama, USA, May
2015.
The graph above shows that the situation for Cention N when used without an adhesive is
similar to the situation with amalgam. That penetration is far lower with an adhesive is entirely
to be expected and here the penetration was lowest at the enamel margin also unsurprisingly
as a more reliable bond can be achieved to enamel than cementum.
Conclusions: This study establishes equivalence with amalgam with regard to dye
penetration and by extrapolation microleakage. It should also be noted however that the clinical
relevance of in vitro microleakage tests has been questioned 34 and that clinically
hypersensitivity and marginal staining and other criteria traditionally associated with
microleakage may be more dependent on the overall caries risk of patients.

4.3 Ion release
4.3.1 Calcium and fluoride release

As noted and depicted in section 2.3.1 the extent of the ion release depends on the pH-value
in the oral cavity. The following graph, shows this effect in practice after storing Cention N for
4 weeks in neutral phosphate (pH 6.8) and acidic lactate (pH 4.0) buffer solutions.
The release of both fluoride and calcium ions is clearly much higher at the lower pH of 4.0,
compared to the near neutral pH of 6.8. The ion release from the self-cured material was
slightly higher than that from the dual-cured material.
Fig. 30: Calcium and fluoride ion release after 4 weeks in acidic and neutral conditions. R&D Ivoclar
Vivadent 2015.
4.3.2 Long term calcium and fluoride release

The comparative long term release of calcium and fluoride ions from Cention N and the glass
ionomer materials Fuji II/GC, Fuji IX GP Fast/GC and Ketal Molar Easymix/3M Espe was
investigated over a period of 180 days (6 months). Measurements were taken at day 1, 7, 14,
21, 28, 55, 92 and 180. Cention N mixed according to the instructions for use and cured for
one hour at 37°C (SC = self-cure mode). Samples of the materials were polished using 1000
grit paper and then placed in a lactate buffer solution with a pH of 4.0 at a temperature of 37°C
or a phosphate buffer solution of pH 6.8. The calcium concentration was determined via atomic
absorption spectroscopy (AAS) and the fluoride concentration was measured using an ion-
selective electrode (ISE).

Calcium ion release
Fig. 31: Cumulated Ca2+ release from various materials at a neutral pH 6.8. R&D Ivoclar Vivadent 2016.
Fig. 32: Cumulated Ca2+ release from various materials at an acidic pH 4.0. R&D Ivoclar Vivadent 2016.
The diagrams above demonstrate the long term ion release and the sustained and
substantially increased calcium ion release at a lower acidic pH of 4.0 compared to the more
neutral pH of 6.8. It should be noted that the y-axis scale is different in figure 31 to figure 32.
Of all the products, Cention N exhibited the highest calcium ion release after 180 days, under
acidic conditions.

Fluoride ion release
Fig. 33: Cumulated F- release from various materials at a neutral pH 6.8. R&D Ivoclar Vivadent 2016.
Fig. 34: Cumulated F- release from various materials at an acidic pH 4.0. R&D Ivoclar Vivadent 2016.
The diagrams above depicting fluoride ion release, demonstrate the long term and sustained,
substantially increased fluoride ion release at a lower acidic pH of 4.0 compared to the more
neutral pH of 6.8. It should be noted that the y-axis scale is different in figure 33 to figure 34.
Thus ongoing ion release was recorded for both calcium and fluoride, 6 months after placing
Cention N in buffer solutions. The release of ions was higher at the lower pH, as would be the
case during cariogenic challenge.

4.3.3 Ion depot formation: Calcium fluoride / Calcium phosphate
To determine and depict the formation of a calcium phosphate, hydroxyapatite and calcium
fluoride layer over the restorative material, SEM photos and EDX analysis were carried out.
Polymerized sample discs of Cention N were prepared with a diameter of 10mm and a height
of 1mm according to the standard ISO 4049. As natural saliva contains high levels of calcium
and phosphate (a potential remineralization source), Cention N discs were stored at 37°C in
an artificial saliva solution for one month (30 days). Calcium fluoride and calcium phosphate
can essentially result from a combination of the ions from both the Cention N material itself
(lower amounts) and from the calcium and phosphate ions (high amounts) in the saliva. The
surface of each disc was photographed before and after storage. A change in the surface of
the specimens after storage was visible.
Fig 35a-b: Surface of Cention N at Baseline (left) and after 1 month in artificial saliva (right).
Magnification 200 x. R&D Ivoclar Vivadent 2016.
After breaking the specimen, a 0.5 µm thick surface layer was also observed, which was
resistant towards rinsing with deionized water.
Fig 36a-b: 0.5 µm thick layer on Cention N surface after 1 month storage in artificial saliva. Magnification
4980 x (left) and 30,000 x (right). R&D Ivoclar Vivadent 2016.

Elemental analysis of the specimen/precipitate was carried out via EDX (energy dispersive
X-ray spectroscopy). The table below shows the chemical composition of the Cention N
specimen at baseline, of the precipitate layer (+ Cention N background) on the surface after
one month storage and of Tetric N-Ceram as a control.
Baseline After 1 Month

Components/Elements Cention N Precipitate + Cention N- Tetric N-Ceram
[wt.-%] background (EDX 1) [wt.-%]
[wt.-%]
Monomer matrix C 26 32 25
Glass filler SiO2 28 8 39
Ytterbium fluoride Yb 12 5 13
Calcium Ca 7 27 -
Phosphate P 0.5 22 -
Fluoride F 4 7 2.6
Table 9: Elemental/component distribution (EDX signals) of Cention N at baseline and of the precipitate
layer (plus Cention N-background) after 1 month storage in artificial saliva with Tetric N-Ceram as
negative control. R&D Ivoclar Vivadent 2016.
The measurements from Cention N at baseline, show the typical composition of a restorative
material. The values after one month, from the precipitate + Cention background section show
far higher signals for Ca, P and F i.e. the presence of CaF2 and Ca3(PO4)2 on the surface of
the restoration due to the ion release from the alkaline glass filler. It can be noted that the
calcium and phosphate levels are considerably higher than the fluoride which is likely due to
the reaction processes with the calcium and phosphate available in high amounts from the
saliva.
To exclude therefore, the possibility that the precipitation layer formation is only (or mostly)
due to the ions contained within the artificial saliva, Tetric N-Ceram (a non ion-releasing
composite) was tested in the same way. No layer was seen after 1 month storage.
Fig 37: Cross section of Tetric N-Ceram after 1 month storage in artificial saliva as a negative control.
Magnification 5010 x. R&D Ivoclar Vivadent 2016.
The EDX signals of the material support this. Tetric N-Ceram (as shown in table 9) only showed
signals from the monomer matrix, glass filler and ytterbium fluoride. There were no signals
indicating CaF2 or Ca3(PO4)2 precipitations.

4.3.4 Hydroxide ion release
As noted in section 2.3.1, as well as fluoride and calcium ions, the alkaline glass of Cention N
releases hydroxide ions, which are able to have a direct effect on the pH level in the oral cavity.
Glass ionomer cement materials do not release hydroxide ions.
In order to test the buffering ability of Cention N, 20 g of phosphate buffer (pH 6.8) was placed
in a 30ml container, and the pH value measured and checked. 5 g of pre-polymerized
Cention N with a particle size of 90 µm was then stirred vigorously into the mixture. Once a
stable pH level was reached, 0.04ml of concentrated lactic acid was titrated into the solution.
After each drop, it was waited until a stable pH value had been re-reached. Over the time
period a total of 0.5ml (500µl) was titrated.
Fig. 38: pH course of Cention N suspension after repeated lactic acid titration. R&D, Ivoclar Vivadent
2016.
The graph above, shows how the pH of the liquid changes over time with successive acidic
challenges. The starting pH of 6.8 rises to between 9 and 10 after the addition of the powdered,
polymerized Cention N material. The graph shows the administration of lactic acid, 12 separate
times and the accompanying, drastic fall in pH. After each fall however the Cention N mixture
is capable of neutralizing the acidity and the pH rises between each lactic acid titration. It can
be seen that the effect carries on however the “recovery” takes longer with increasing time.
The pH at 5.7 is indicated as critical as this is the lower pH threshold used by the international
Tooth Friendly Association to determine if products have a significant erosive potential i.e. if
in in vivo tests plaque pH falls below 5.7 after consumption of the product – it is not deemed
“tooth friendly” In conclusion, in this test, Cention N is able to neutralize multiple acid
challenges over a short time period, and to repeatedly return the pH to around the neutral (pH
7) region i.e. well above the “critical level” of 5.7.

4.4 Flexural and Compressive strength
4.4.1 Flexural strength
Flexural strength is a measurement of a material’s ability to resist fracture.35 In a review of the

clinical relevance of certain laboratory tests. Heintze et al note that flexural strength
measurements in particular, do correlate with clinical performance – showing that composite
fillings with a flexural strength less than that stipulated by the ISO standard 4049 for polymer-
based restorative materials (80 MPa) tend to exhibit more fracturing.35
The graph below shows the flexural strength values for Cention N (SC) and two glass ionomer
cements Fuji IX GP/GC and Ketac Molar Easymix/3M Espe. Testing was carried out according
to the standard ISO 4049:2009. After curing for the manufacturer’s recommended time the
samples were placed in a water bath at 37°C . Sixty minutes after mixing began the samples
were detached and testing started. It can be seen that the flexural strength of Cention N is
considerably higher than the glass ionomer materials.
Fig. 39: Flexural strength of Cention N and two standard glass ionomer cement materials. R&D Ivoclar
Vivadent 2016.

Recent advances in glass ionomer restoratives have seen indications widened to include
stress-bearing Class II restorations for certain products. It can be assumed that glass ionomer
fillings would also need to fulfil similar levels of flexural strength (80MPa) if they are to be used
as stress-bearing posterior fillings. In the diagram below comparing two such new generation
GIC materials, Ketac Universal Aplicap/3M Espe and Equia Forte/GC with Cention N, it can
be seen that Cention N exhibits far higher flexural strength than the glass ionomer materials
and the values are similar to the standard glass ionomer cements shown in Fig 39.
Fig. 40: Flexural strength of 2 newer generation GICs and Cention N. R&D Ivoclar Vivadent 2016.

Flexural strength over time
The flexural strength of Cention N, Fuji II/GC and Fuji IX GP Fast/GC were measured over a
period of 180 days. Measurements were taken at day 1, 7, 30, 90 and 180. Products were
mixed according to the instructions for use, then pressed into a sample-mould 25 x 2 x 2 mm
on top of a transparent foil and covered with a second foil and a metal cover. Pressure was
applied via a clamp to press out excess material. Subsequently the whole sample set-up was
immersed in demineralized water at 37°C, and one hour after initial mixing the samples were
carefully removed from the moulds. Excess material was removed with sandpaper and
samples were then stored in either phosphate (pH 6.8) or lactate buffer (pH 4.0) for the various
time periods mentioned above.
Fig. 41: Flexural strength of Cention N and GIC materials at neutral pH 6.8. R&D Ivoclar Vivadent 2016.
Fig. 42: Flexural strength of Cention N and GIC materials at acidic pH 4.0. R&D Ivoclar Vivadent 2016.

The graphs show a relatively constant flexural strength of around 100 MPa over the extended
time period. The flexural strength remains above 100 MPa at neutral pH over the 6 month time
period. At an acidic pH, strength is only slightly lower. The flexural strength of Cention N is
considerably higher than glass ionomer materials and remains above 80 MPa the minimum
suitable value given by the ISO Norm 4049 for polymer-based stress-bearing restorations.
4.4.2 Compressive Strength

Compressive strength is the ability of a material to resist compression. In the dental field, this
method is often applied to test the strength of traditional glass ionomer cements which set via
an acid base reaction (Standard ISO 9917-1). Flexural strength tests however tend to be used
for resin modified glass ionomer cements (ISO 9917-2) and composite materials (ISO 4049).
As Cention N is a full volume replacement material (like GICs) that includes a self-curing
initiator system, compressive strength tests (according ISO 9917-1) were also carried out with
the material.
Fig. 43: Compressive strength comparison of Cention N and GIC materials. R&D Ivoclar Vivadent 2016.
Cention N exhibits higher compressive strength than the glass ionomer materials.

4.5 Linear Expansion
In order to ensure the volumetric stability of Cention N, the product was also investigated with
regard to linear expansion. Both self-cured and dual-cured samples were tested. The graph
below shows that after minimal linear expansion within the first 3-4 weeks of approximately
0.25 to 0.3% (compared to the outset), afterwards there is no discernible change in expansion
whether Cention N is self-cured or (light) dual-cured. This effect proved stable over a one year
time period.
Fig. 44: Percentage linear expansion of Cention N (SC and DC) over one year at pH 6.8 and 37°C. R&D
Ivoclar Vivadent 2016.
The results shown above are also backed up by artificial aging tests carried out on extracted
human teeth filled with Cention N. These were exposed to thermocycling (10,000x) between
5°C and 55°C and water storage for 12 months (6 months shown below). Teeth were then
examined with a transmission light microscope and no cracks were seen i.e. there was no
suggestion of weakness due to material expansion over time.
Fig. 45: Extracted human teeth filled with Cention N showing no cracks after thermocycling and after 6
months water storage. R&D Ivoclar Vivadent 2016.

4.6 Powder/Liquid mix ratio: User-tolerant material
Cention N is a material that is handmixed in the liquid/powder ratio 1:4.6. In clinical conditions
where speed is of the essence such as when treating children or working under field conditions,
it may be that the powder liquid ratio varies slightly e.g. if the amount of powder in the
measuring spoon is slightly less or slightly heaped. Sample mixes were therefore prepared
with both less powder (ratio 1:3) and more powder (ratio 1:6) than detailed in the instructions
for use. The flexural strength, volumetric shrinkage, working time and setting time of the
“incorrectly” mixed materials were tested alongside the standard mix ratio of Cention N.
4.6.1 Flexural Strength with variable mix ratios
Fig. 46: Flexural strength of different liquid/powder mix ratios of Cention N (SC). R&D Ivoclar Vivadent
2015.
Each mix ratio (tested according to ISO 4049:2009) exhibits a flexural strength well over the
80 MPa given by the ISO Norm 4049 for polymer-based stress-bearing restorations as a
minimum acceptable value.
4.6.2 Volumetric Shrinkage with variable mix ratios
Fig. 47: Volumetric shrinkage in different liquid/powder mix ratios of Cention N. R&D Ivoclar Vivadent
2016.

4.6.3 Working time with variable mix ratios
Fig. 48: Working times of different liquid/powder mix ratios of Cention N. R&D Ivoclar Vivadent 2016.
4.6.4 Setting times with variable mix ratios
Fig. 49: Setting times* of different liquid/powder mix ratios of Cention N. R&D Ivoclar Vivadent 2016.
Each mix ratio exhibits a setting time of less than the 300 seconds (5 minutes) stipulated by
the ISO Norm 4049 for polymer-based restorations, as a maximum acceptable value.
In the tests carried out above, it can be seen that there is relatively little change in flexural
strength, volumetric shrinkage, working time or setting time if the mixing ratio differs somewhat
from the recommended ratio. The material is relatively *forgiving” and in that sense user-
friendly.
* The setting time in the Instructions for use is indicated as 4 minutes (240s) in total which is also less than the ISO designated
300 seconds. The discrepancy in time with the graph above is because the final setting time was stipulated by clinical handling
tests rather than in vitro testing

4.7 Wear
Ivoclar Vivadent uses a Willytec chewing simulator to measure the wear resistance of
restorative materials. The aim is to emulate mastication processes using a standardized
procedure in order to obtain results that can be compared with each other.
Wear tests were carried out with both self-cured and dual-cured Cention N material. The dual-
cured samples were light-cured from above for 10 seconds with Bluephase Style (1,100
mW/cm2). All samples were stored for 24 hours at 37°C. The samples were then exposed to
material wear in the chewing simulator for 120,000 chewing cycles, with a force of 50 N and a
sliding movement of 0.7 mm - using IPS Empress MT as an antagonist. Vertical substance
loss was measured by means of a 3D laser scanner. A vertical loss of 200 μm is considered
low and above 680 is considered unacceptable.
Fig. 50: Mean vertical wear of Cention N (and antagonists) when self-cured or dual-cured. R&D Ivoclar
Vivadent 2015.
The mean vertical wear for Cention N at 327.1 µm when self-cured and 309.7 µm when dual
cured, can be considered medium. Antagonist wear was similar at 90 and 78 µm respectively.
Importantly, there was no statistically significant difference between Cention N when self-cured
or dual-cured – i.e. the type of polymerization had no effect on the wear characteristics of the
material.

The following graph shows the wear values compared with other glass ionomer cements:
Fig. 51: Comparison of wear in Cention N and GIC materials. R&D Ivoclar Vivadent 2016.
The wear values for Cention N are considerably lower than those for Fuji IX GP/GC and Ketac
Molar/3M Espe.

4.8 Caries Inhibition
Background: Marginal defects do not always lead to marginal secondary caries; rather the
development of caries is more dependent on the caries risk of specific individuals.34 Marginal
caries can also occur when there are no discernable marginal defects. The development of
caries at the margin of a standard (non ion-releasing) material can be explained with the
following diagrams:
Schematic representation of a plaque biofilm

covering the junction of the enamel and filling
material
When fermentable sugar is made available to the

plaque biofilm, acid production begins - denoted by
the proliferation of protons/ hydrogen ions (H+).
The pH in the biofilm falls, and the H+ protons
diffuse into the enamel (acid attack). Filling
materials remain ordinarily inert under acid
conditions
In response to the acid attack calcium and

phosphate ions are released from the
hydroxyapatite of the enamel, neutralizing the
milieu – i.e. the level of H+ is kept low (higher pH).
The filling material however does not “absorb” H +
and therefore these are higher in level over the
restoration i.e. the pH falls more over the
restorative than over the enamel.
The differences in concentration of proton, calcium

and phosphate ions over the enamel and filling
material, leads to horizontal diffusion within the
biofilm. H+ move from the restorative surface to the
enamel surface and calcium and phosphate ions
move in the opposite direction. Comparatively
more ions are released from the hydroxyapatite at
the margin of the filling material in order to
neutralize the excess of H+ from over the filling
material. The result is that demineralization is
greatest at the margin.
Table 10: Schematic representation of biofilm formation, and ion exchange over enamel and a non-ion
releasing filling material leading to marginal caries. R&D Ivoclar Vivadent 2016.
The demineralization resulting at the margin is independent of there being a marginal gap but
can arise simply due to the differential ion exchange situation over different substrates. The
same effect in a neighbouring tooth is also possible in the case of Class II fillings placed
approximally. The “inert” filling surface placed in one tooth can affect the enamel of the
adjacent tooth in the same way as depicted above. Skudutyte-Rysstad et al 36, showed that an
approximal filling increased the likelihood of caries in the adjacent tooth by a factor of 3. It
follows that a filling material that releases remineralizing ions should provide a way of
minimizing the processess described above.

4.8.1 Caries/demineralization inhibition due to Cention N
Objective: To investigate whether Cention N, an ion-releasing basic filling material reduces

demineralization at the enamel/filling junction, more than Tetric N-Ceram (a non ion-releasing
composite) under the same cariogenic-challenge conditions in vitro.
Methods: The investigation compared Cention N and Tetric N-Ceram, using the fluoride
releasing glass ionomer Fuji IX/GC as a control. Twelve bovine teeth were embedded in resin
and sanded down to expose the enamel surface. Cavities were prepared on either side
(left/right) of the test specimens (length: 11mm, depth: 2mm, width: 5 or 2mm). The cavities
were then filled with the filling materials (no adhesive) as shown in the diagram below.
Fig. 52: Schematic representation of size and positioning of

fillings in caries inhibition test. R&D Ivoclar Vivadent 2016.
The green colour on the left represents the positioning

of the test materials Cention N or Fuji IX. The grey
colour in the middle indicates the 5mm enamel area left
clear and the red colour on the right shows the
positioning of the reference material Tetric N-Ceram.
Of the twelve teeth (filled on 2 sides), 6 received Fuji IX (5mm (n=3) or 2mm (n=3)) and Tetric
N Ceram and 6 received Cention N (5mm (n=3) or 2mm (n=3)) and Tetric N Ceram.
Cention N and Tetric N Ceram fillings were light cured for 3 minutes in a Spectramat unit. All
samples were then stored in water for 24 hours at 37°C to ensure complete polymerization. All
the fillings were polished to a high gloss.
A strip of plastic tape (Scotchtape) was placed horizontally over the bottom third of the
specimen covering the test material, the free enamel (in the middle) and the Tetric N-Ceram.
This provided an enamel control-surface (no demineralization) in terms of microhardness.
The specimens were disinfected and then exposed to a simulated “caries attack” utilizing BHI
(brain heart infusion for bacterial growth), S. mutans, bacitracin an antibiotic that S. mutans is
generally resistant to, enabling in order to avoid other bacterial contamination and sucrose.
The caries challenge was carried out in steps with fresh BHI, bacitracin etc. administered as
shown in the table below
Time Caries Attack

1st Day Preparation
1st Night (16h) BHI Medium/Bacitracin/S. mutans inoculation
2nd Day (8h) BHI Medium/Bacitracin/Sucrose powder 1%
2nd Night (16h) BHI Medium/Bacitracin
3rd Day (8h) BHI Medium/Bac/ Sucrose powder 1%
Table 11. Simulated caries attack over 2 days and nights. R&D Ivoclar Vivadent 2016.
Following the caries attack, specimens were placed in deionized water, the plastic tape
removed and the biofilm mechanically removed with a brush. The specimens were then
disinfected with 70% ethanol for 15 minutes and stored in tap water until they were evaluated.

Microhardness
The microhardness of the enamel was then measured using an nanoindenter at the margins
of the different filling materials and at increasing distances (in 20-100µm intervals) from the
restorative materials towards the centre of the specimens. Microhardness (Vickers hardness
calculated from indentation hardness) was measured at five separate points from the test
materials, and also in the centre, at five points under the plastic tape. An average hardness for
each point was calculated based on 3x testing from the control and test material margins;
whereas under the plastic tape the hardness was just recorded once.
Test material
material
Control
Plastic Tape
Fig.53: Schematic representation of the microhardness tests on the bovine enamel adjacent to the
Cention N/Fuji IX and Tetric N-Ceram restorations after simulated caries challenge. R&D Ivoclar
Vivadent 2016.
Fluorescence microscopy
The surfaces of the specimens were captured using fluorescence microscopy. Healthy enamel
appears brighter than demineralized tooth substrate.
Fluorescence infiltration
Surface infiltration tests were also carried out by first etching the specimens for 30s with Email
Preparator, rinsing with water, drying and then applying Heliobond (dyed with 0.025%
fluorescent red colour) for one minute under yellow light conditions to prevent polymerization.
Excess was removed with a paper towel and the material was then light-cured for 30s. The
samples were covered with casting-resin and then 1.5 mm thick cross sections were taken and
evaluated with fluorescence microscopy. Deeper sections of infiltrated Heliobond indicated
larger sections of demineralization.

Results:
Microhardness
The enamel adjacent to the ion releasing Cention N or Fuji IX fillings was almost always
considerably harder than the enamel adjacent to the Tetric N-Ceram fillings. In general, the
enamel also exhibited considerably higher hardness values in the specimens receiving 5mm
wide fillings as opposed to 2mm. The four graphs below show the average hardness values
based on the 3 specimens in each group.
Figs 54a-b: Average microhardness values of adjacent enamel areas in specimens with Fuji IX and
Tetric N-Ceram. Left: Fuji IX with 5mm width. Right: Fuji IX with 2mm width. R&D Ivoclar Vivadent 2016.
In the specimens with Fuji IX (see graphs above), the isolated area exhibits the highest
hardness values over the entire measured area (yellow line). The hardness values for the
enamel adjacent to the Fuji IX restoration (green line) are higher those of the enamel adjacent
to the Tetric N-Ceram restoration (red line). The hardness values for the 5mm wide Fuji IX
restoration are higher (left graph) than those of the 2mm wide restoration (right graph).
Figs 55a-b: Average microhardness values of adjacent enamel areas in specimens with Cention N and
Tetric N-Ceram. Left: Cention N with 5mm width. Right: Cention N with 2mm width. R&D Ivoclar Vivadent
2016.

In the specimens with Cention N (see graphs above), the isolated area exhibits the highest
hardness values over the entire measured area (yellow line). The hardness values for the
enamel adjacent to the Cention N restoration (blue line) are consistently higher those of the
enamel adjacent to the Tetric N-Ceram restoration (red line). The hardness values for the 5mm
wide Cention N (left graph) restoration are higher (left) than those of the 2mm wide restoration
(right graph). Both the glass ionomer cement Fuji IX and Cention N provided demineralization
protection in these tests.
Fluorescence microscopy
In all cases the reference surface of unexposed enamel (covered by the plastic tape) was also
brighter than the surface that was exposed to the caries attack. This concurs with the
mircohardness results.
The picture below shows a typical specimen with Cention N (left) and Tetric N-Ceram (right).
The former position of the Scotchbond tape in the bottom third of the picture is shown and the
area can be discerned as distinctly brighter. The green area on the left is also brighter than the
area on the right (see arrows). That is, the area adjacent to Cention N (left) exhibited less
demineralization and fluoresces more than the area next to the non-ion releasing Tetric
N-Ceram filling (right).
Fig 56: Image (using fluorescence microscopy)

of enamel of specimen with 2mm Cention N (left)
and 5 mm Tetric N-Ceram (right), after removal
of plastic tape. R&D Ivoclar Vivadent 2016.
This effect could also be seen to a certain degree on the images of the Fuji IX (GIC) plus Tetric
N-Ceram specimens.

Fluorescence infiltration
5mm wide Cention N restorations
Fig 57a-b: Fluorescence infiltration images of enamel margins after application of red dyed Heliobond
to specimens with 5mm wide Cention N (a: left) and Tetric N-Ceram (b:right) restorations. R&D Ivoclar
Vivadent 2016.
The fluorescence infiltration images for the enamel margins adjacent to Cention N showed no
infiltrated red fluorescence in specimens with 5mm wide restorations. The specimen above
with Tetric N-Ceram showed minimal infiltration indicated by the red/orange strip.
2mm wide Cention N restorations
Fig 58a-b: Fluorescence infiltration images of enamel margins after application of red dyed Heliobond
to specimens with 2mm Cention N (a: left) and Tetric N-Ceram (b:right) restorations. R&D Ivoclar
Vivadent 2016.
The images for Cention N in 2mm wide format showed some very minimal infiltration compared
to none in the 5mm restorations and the infiltration adjacent to the Tetric N-Ceram is somewhat
greater.
Conclusion: Under the experimental conditions described, both ion releasing materials
Cention N and Fuji IX led to noticeably reduced demineralization (measured in terms of
microhardness, surface and infiltration fluorescence) of enamel adjacent to the materials in
comparison to a non-ion releasing material. The larger the amount of material (5mm vs. 2mm)
the greater this effect was.

In vitro enamel/dentin demineralization inhibition at restoration margins. Final Report
to Ivoclar – March 2016
Kevin Donly, Department of developmental dentistry, University of Texas, San Antonio, Texas, USA
Objective: To determine the demineralization inhibition potential of Cention N, a material

capable of releasing fluoride, calcium and hydroxide ions and to compare this with a non-
fluoride-releasing resin and a resin-modified glass ionomer cement.
Methods: Thirty extracted permanent molars had Class V preparations placed on the buccal
surface with the occlusal margin in enamel and the gingival margin in dentin/cementum. All
tooth surfaces had an acid-resistant varnish placed to within one millimeter of the preparation
margins. Randomly, ten teeth received the ion releasing Cention N material, ten a non-
fluoridated composite (plus adhesive) (Z 100/3M Espe) as a negative control and ten a resin-
modified glass ionomer cement (Vitremer/3M Espe) as a positive control. Each group of ten
teeth was placed in an artificial saliva solution that was refreshed every two days. Twice per
day all groups were separately thermocycled in 55 and 5°C distilled water baths for 36 cycles
per day with 30s dwell times in each bath. Likewise twice per day, groups were separately
immersed into an artificial caries solution for one hour each immersion. After two weeks, teeth
were sectioned buccolingually through the teeth and restorations to obtain 100µm sections
and then photographed using polarized light microscopy. Using a computerized imaging
system the areas of the lesions adjacent to the enamel and dentin/cementum restoration
margins were measured 100µm from the restoration margins.
Results: The mean areas of demineralization (µm2) for the groups, 100 µm from the restoration
(enamel) occlusal margin and the (dentin) gingival margin are shown in the graph below.
Fig 59: Mean areas of demineralization 100µm from the (enamel) occlusal margin and the (dentin)
gingival margin (µm2) in different restorative materials. Donly, University of Texas, USA, March 2016.
Enamel margin: Vitremer exhibited significantly less demineralization at the enamel junction
than both Cention N and Z100 and Cention N exhibited significantly less demineralization than
the composite Z100.
Dentin margin: Similarly Vitremer exhibited significantly less adjacent demineralization than
both Cention N and Z100 and again Cention N exhibited significantly less demineralization
than Z100. The images below illustrate the dentinal margins for Cention N and Z100.
Cention N Z100
Fig. 60a-b: Polarized light microscopy images of the dentinal junction of a Cention N (left) and a Z100
restoration (right). D=Dentin, R=Restoration, C=Caries, RTI=Restoration Tooth Interface, WL=Wall
Lesion. Donly, University of Texas, USA, March 2016.
The image of the composite (right) shows a wall lesion (WL) forming. No wall lesions were
found in any of the Cention N specimens.
Conclusions: The ion releasing materials Vitremer and Cention N exhibited significantly less
demineralization at both enamel and dentin junctions compared to the non-ion releasing
composite product Z100. Vitremer exhibited the least demineralization in this study. Wall
lesions occurred in 40% of the Z100 samples, however no wall lesions were seen in either the
Vitremer or Cention N groups and any demineralization was uniformly shallow right up to the
restoration margin.
4.9 Summary
From the various in vitro tests carried out it was found that Cention N released F- and Ca+ ions
over an extended time period, underwent no significant dimensional change and maintained
its flexural strength long term. No tooth fracture was seen and wear was acceptable. When
used in slightly different mixing ratios the differences with regard to flexural strength and
shrinkage were negligible i.e. the product proved forgiving and user friendly. The product cures
equally well in self-cure or dual cure mode, is radiopaque, blends well with the surrounding
tooth structure and is more translucent than standard glass ionomer cements. Cention N also
noticeably reduced demineralization in adjacent enamel.
Cention N, the alkasite restorative is an esthetic, strong, dual-cure, user-friendly, ion-releasing
basic filling material

5. Clinical Investigations with Cention N
Clinical evaluation of Cention N basic filling material in Class I and II cavities without
the use of an adhesive resin: A prospective controlled clinical trial of up to 3 years.
August 2016.
6-month results
Özcan M1, Öztürk-Bozkurt F2, Toz T2, Kuşdemir M2, Özsoy A2, Yüzbaşioğlu E2.
1Universityof Zurich, Dental Materials Unit, Center for Dental and Oral Medicine Clinic for Fixed and
Removable Prosthodontics and Dental Materials Science, Zurich, Switzerland. 2Medipol University, Dental
School, Center for Restorative and Regenerative Medical Research, Biomaterials and Translational Dental
Research Laboratory, Istanbul, Turkey.
Objective: To evaluate the clinical performance of Cention N in Class I and II cavities in

permanent teeth.
Methods: Between July and October 2015, 50 patients (29 women and 21 men) aged 18 to
70 years old, with good to moderate oral hygiene, referred to the Department of Restorative
Dentistry at the Medipol University were recruited to the study. In total, 88 Class I and II fillings
were placed in vital premolars or molars, of which 51 were in the maxilla and 37 in the
mandible. Each patient received a maximum of two fillings. Two operators performed all the
restorations (45 and 43 each). The reasons for fillings, were largely primary caries (n=72)
followed by existing filling replacement (n=16). Of the 88 fillings, 21 were 3-sided MOD, 55
were 2-sided MO/DO/BO and 12 were 1-sided occlusal fillings. The cavities ranged between
1 and 6.75 mm in depth and 0.75 and 6.5 mm in buccolingual dimension.
Isolation was carried out using cotton rolls and suction, and local anesthesia was used when
necessary. A metal matrix band and wooden wedge were placed for separation and a calcium
hydroxide cavity liner was used (Dycal/Dentsply) in deep cavities (n=50). All restorations were
applied in bulk without an adhesive resin and the setting time of the material was limited to 4
minutes. After setting, premature contacts were controlled using carbon paper and
interproximal contacts were checked with dental floss. Adjustments were made where
necessary and restorations were finished under water-cooling with finishing burs and polishing
instruments (Opti Disc/Kerr and Optrapol/Ivoclar Vivadent). Periapical radiographs were made
at baseline and after the completion of each filling.
The evaluation protocol was carried out according to FDI criteria (Scores 1-5) by two
independent, calibrated observers. Baseline recordings were carried out at 2 weeks and the
first follow up at 6-months. Annual follow-ups are planned up to 3 years.
Results: At baseline, two patients with four fillings could not be followed up due to moving/non-
response. The baseline results, are therefore based on 84 fillings in 48 patients. Post-operative
sensitivity was noted in nine cases, however this problem had disappeared after one month in
all cases without any specific intervention.
At the 6-month recall, 64 (64/84 = 76%) restorations could be followed up. There were no
debondings, fractures, cases of secondary caries or endodontic complications. Patients
themselves rated the fillings as highly satisfactory with 63 patients (98%) giving their fillings
the highest score of 1 – meaning they were entirely satisfied with esthetics and function.

The graph below presents various FDI criteria that were evaluated and the percentage of
restorations that scored 1 or 2 i.e. clinically excellent or good.
Fig. 61: Percentage of restorations scoring 1 or 2 according to FDI criteria, for various characteristics at
baseline (n=84) and after 6 months (n=64). Özcan et al, University of Zurich, Switzerland & Medipol
University, Turkey, August 2016.
All the characteristics were rated overwhelmingly with high (1 or 2) scores at both baseline and
after 6 months in situ. For marginal gap, material fracture / retention, secondary caries and
tooth integrity (marginal) 100% of the restorations scored 1 or 2 for the entire study period, and
for marginal gap, material fracture / retention and tooth integrity (marginal) all the scores were
1. A greater distribution of scores was seen regarding esthetic features such as colour match
with the tooth and surface staining. In total, 96% received score 1 or 2 for colour match, falling
to 89% after 6 months. Seven restorations (11%) were also scored 3 after 6 months, meaning
that these restorations exhibited certain acceptable deviations from the ideal. Regarding
surface staining, 98% received scores 1 or 2 at baseline, dropping to 94% after 6 months.
Altogether, 99% scored 1 or 2 for surface lustre, dropping minimally to 97% after 6 months,
however most of these scores were 2s meaning clinically good but not excellent i.e. slightly
dull. The pictures below show a representative case where 2 neighbouring teeth received
Cention N fillings.
Fig. 62a-c: Representative clinical case in which 2 teeth received Cention N fillings: Left to right: a)
Baseline situation, b) After cavity preparation, c) Restorations with Cention N. Özcan et al, University of
Zurich, Switzerland & Medipol University, Turkey, August 2016.
Conclusion: Over the six-month follow-up period, Cention N fillings performed well. Patient
satisfaction was high and there were no debondings, fractures, endodontic complications or
incidences of secondary caries.

Clinical evaluation of an amalgam replacement dental filling material: 6-month recall
John Burgess, Nathaniel Lawson, University of Alabama - School of dentistry, Birmingham, AL, USA.
August 2016
Objective: To assess the clinical performance of an innovative, esthetic, fluoride-releasing
filling material Cention N (with and without adhesive) compared to amalgam restorations
(Valiant) in a prospective, randomized, controlled clinical study.
Methods: 41 patients received sets of 3 Class I or Class II fillings, one Cention N filling (without
adhesive), one Cention N filling (with adhesive) and one amalgam (Valiant) filling. One of the
41 patients received 2 sets of restorations. Six operators carried out the restorations. 29%
were Class I fillings and 71% Class II. 40% were in premolars and 60% in molars. The
restorations were evaluated according to modified FDI criteria (Scores 1-5). The cold response
(hypersensitivity) was measured by applying a cotton pellet soaked in Endo Ice to the restored
tooth for 3 seconds and asking the subject to record the level of discomfort from 1-10 (10 being
worst pain imaginable), by marking an X along a 10mm line. The baseline data was collected
approximately two weeks after treatment with follow ups conducted after 6 months.
Results: 41 patients and 126 fillings were evaluated at baseline, while 38 patients and 115
restorations were evaluated at the 6-month recall (93% patient / 91% filling retention rate). Two
restorative failures occurred in different patients. One Cention N restoration (without adhesive)
was replaced due to debonding. This patient suffered from bruxism and the geometry of the
cavity was unsuitable (minimal retentive slot). Another Cention N restoration (with adhesive)
was replaced due to hypersensitivity.
Fig. 63: Percentage of Cention N (with and without adhesive) and Valiant restorations scoring 1 or 2 for
various FDI evaluation criteria, after 6 months in situ. Burgess et al, University of Alabama, USA, August
2016.
At baseline a significantly higher cold response was recorded by patients for Valiant (76% no
sensitivity) than for Cention N (88% no sensitivity (with adhesive) and 86% no sensitivity
(without adhesive)). The difference between Cention N with and without adhesive was not
significant. Figure 1 shows the percentage of restorations scoring 1 or 2 for various categories
after six months in situ. Cention N scored 1 or 2 i.e. clinically excellent or good for over 90%
of the restorations in most categories. In general, the Cention N results were similar to those
with amalgam (Valiant).

Regarding marginal adaptation, it should be noted that although the percentage was minimally
higher for Cention N without adhesive, the group with adhesive scored more 1s than 2s than
the group without. The percentage of scores 1 and 2 for surface lustre were far lower in the
Cention N fillings compared to Valiant, however regarding colour match, 85% of the Cention
N fillings were rated 1 or 2 overall i.e. good match or minor deviations. Amalgam was not
evaluated in this category.
Conclusions: Overall, Cention N scored 1 or 2 i.e. clinically excellent or good for over 90% of
the restorations in most categories. The results were largely similar to the amalgam (Valiant)
restorations. Cention N with and without adhesive performed similarly but the restorations with
adhesive tended to slightly higher scores. As was expected, surface lustre with Cention N was
significantly lower than Valiant due to the gloss that can be achieved with amalgam, however
this is less of an esthetic drawback when comparing a tooth coloured material with a grey
amalgam.
Further studies
The following clinical investigations with Cention N are also currently running or are planned:
Investigator University / Location Study Title / Description
Arianto University of Indonesia, Clinical performance of new filling material as

Jakarta, Indonesia posterior tooth restorative
Baratieri Federal University of Santa Randomized controlled clinical trial of Class I
Catarina, Florianópolis, Brazil restorations (SC with and without adhesive, DC
with and without adhesive
Durward University of Puthisastra, Cention N vs Fuji IX (GIC) restorations in class I
Phnom Penh, Cambodia and II cavities in the permanent teeth of 10-15
year old children.
Kasim University of Malaya, Kuala Clinical performance of Cention N in occlusal and
Lumpur, Malaysia posterior interproximal restorations: A longitudinal
study
Loguércio State University of Ponta Cention N in primary teeth. First restorations
Grossa, Brazil placed.
Table 12: Overview of in vivo studies pending or running with Cention N basic filling material

6. Biocompatibility
Ivoclar Vivadent products often incorporate tried and tested ingredients that have proven
clinically successful in other products. This helps minimise any risks related to biocompatibility
from the outset.
Cention N, was developed using existing resin/composite technology. The monomers and the
majority of the fillers have been used previously in various polymer based restoratives – such
as Tetric N-Ceram and Tetric N-Ceram Bulk Fill.
The biocompatibility and toxicological features of Ivoclar Vivadent materials are tested at an
independent facility. Cention N liquid and powder were tested separately as was the final
material in its polymerized state.
6.1 Cytotoxicity
Cention N Liquid was tested at various concentrations using the XTT test, utilising the mouse
cell line L929. In this test L929 cells are brought into contact with the extracts to be tested and
later tested for vitality with the help of tetrazolium dye (XTT). Using concentrations up to the
point that the liquid precipitated – elicited no cytotoxic effects [1].
Cention N Powder was tested in the same way as Cention N Liquid and also elicited no
cytotoxic effects [2].
Polymerized Cention N in various concentrations from 3% to 100% was also tested. No

cytotoxic effects were observed at any concentration [3].
6.2 Mutagenicity
Cention N liquid underwent an in vitro, mammalian cell gene mutation test utilising mouse
lymphoma L5178Ycells. It was observed whether mutations in the thymidine kinase locus
(TK+/-) of mouse lymphoma cells were induced by exposure to the liquid in the absence or
presence of metabolic activation. No mutations were seen, thus Cention N Liquid is considered
non-mutagenic according to this test. [4].
Cention N powder was tested in the same way as Cention N Liquid. No mutations were seen,
thus Cention N Powder is considered non-mutagenic according to this test. [5].
Polymerized Cention N was tested using a standard Ames test set-up i.e. a bacterial reverse
mutation test with strains of Salmonella typhimurium and Escherichia coli. Extracts of
polymerized Cention N were found to be non-mutagenic in this test i.e. no gene mutations by
base pair changes or frameshifts in the genome of the bacterial strains were observed [6].
6.3 Irritation and sensitization

Like most resin-based, light-curing dental materials, Cention N contains dimethacrylates.
These materials (notably in their uncured state), may have an irritating effect and may cause
sensitisation. This can lead to allergic reactions, such as contact dermatitis. Allergic reactions
are very rare in patients but occur more frequently among dental staff, who handle uncured
material on a daily basis. Such reactions can be minimized/avoided by clean working
conditions and avoiding skin contact with uncured material. It should be noted that
commercially available medical gloves do not provide effective protection against the
sensitizing effects of methacrylates [7], [8].

Cention N liquid, powder or uncured mixed material should not come into contact with skin or
mucous membranes and the product must not be used in patients who are known to be allergic
to any of its constituents.
On the basis of cytotoxicity data and copious clinical experience with similar existing products,
it can be concluded that according to the current standard of knowledge, Cention N does not
cause mucosal or gingival irritation when used according to the instructions for use.
6.4 Conclusion
On the basis of the data available and worldwide use of similar materials, it can be concluded
that the benefits provided by Cention N, exceed any potential risk, providing that the
instructions for use are followed carefully.
Biocompatibility References:
[1] Heppenheimer A. Cytotoxicity assay in vitro (XTT-Test) Harlan Report No. 1656601. 2014.
[2] Heppenheimer A. Cytotoxicity assay in vitro (XTT-Test). Harlan Report No. 1656602. 2014.
[3] Heppenheimer A. Cytotoxicity assay in vitro (XTT-Test) Harlan Report No. 1657001. 2014.
[4] Wollny H. Cell Mutation Assay at the Thymidine Kinase Locus (TK +/-) in Mouse Lymphoma L5178Y
Cells. Harlan Report No. 1667303. 2015.
[5] Wollny H. Cell Mutation Assay at the Thymidine Kinase Locus (TK +/-) in Mouse Lymphoma L5178Y
Cells. Harlan Report No. 1667600. 2015.
[6] Sokolowski A. Salmonella typhimurium and Escherichia coli reverse mutation assay. Harlan Report
No. 1657002. 2014.
[7] Geurtsen W. Biocompatibility of resin-modified filling materials. Crit Rev Oral biol Med 2000;11:333-
335.
[8] Munksgaard EC, Hansen EK, Engen T, Holm U. Self reported occupational dermatological reactions
among Danish dentists. European Journal of Oral Sciences 1996;104:396-402.

7. References
1. Sakaguchi R L, Powers J M. Craig’s Restorative Dental Materials, 2012. 13th Edition. Elsevier
2. Sidhu S K. Clinical evaluations of resin-modified glass-ionomer restorations. Dent Mater. 2010; 26
(1): 7-12
3. Nicholson J W, Swift E J. Ask the Experts: Is there a place in dentistry for compomers. Journal of
Esthetic and Restorative Dentistry 2008; 20 (1) 3-4, Article published online.
4. Anusavice K J. Phillips’ science of dental materials, 2003. Eleventh Edition. Elsevier Science
5. ADA Council on scientific affairs. Dental amalgam: Update on safety concerns. JADA 1988; 129: 494-
503
6. Scientific opinion on the safety of dental amalgam and alternative dental restoration materials for
patients and users. May 2008. Scientific Committee on emerging and newly identified health risks
(SCENIHR) European Commission. Health & Consumer protection directorate general.
7. Options for reducing mercury use in products and applications, and the fate of mercury already
circulating in society. Final Report September 2008. European Commission Directorate General
Environment. COWI
8. Study on the potential for reducing mercury pollution from dental amalgam and batteries. Draft Final
Report. March 2012. European commission. Directorate General – Environment.
9. Opinion on the environmental risks and indirect health effects of mercury in dental amalgam. Scientific
opinion May 2008. Scientific Committee on Health and Environmental Risks. (SCHER). European
Commission. Health & Consumer Protection Directorate General.
10. SCENIHR (Scientific Committee on emerging and newly identified health risks). Scientific opinion on
the safety of dental amalgam and alternative dental restoration materials for patients and users
(Update). 29 April 2015. European Commission. Health & Consumer protection directorate general.
11. Study on the potential for reducing mercury pollution from dental amalgam and batteries. Final Report.
July 2012. European commission. Directorate General – Environment.
12. White Paper: FDA Update/Review of potential adverse health risks associated with exposure to
mercury in dental amalgam. National Center for Toxicological Research. U.S. Food and Drug
Administration. Presented August 2006. Finalized July 2009 including Addendum see (14)
13. Addendum to the White Paper. Addendum to the Dental Amalgam White Paper: Response to 2006
Joint Advisory Panel Comments and Recommendations. Center for Devices and Radiological Health.
U.S. Food and Drug Administration. July 2009.
14. ADA Council on Scientific Affairs. Literature review: Dental amalgam fillings and health effects.
Amalgam Safety Update. September 2010
15. ADA Council on Scientific Affairs: Statement on Dental Amalgam. August 2009
16. Kent B E, Lewis B G, Wilson A D. The properties of a glass ionomer cement. Br. Dent J 1973; 135 (7):
322-6
17. Lohbauer U. Dental glass ionomer cements as permanent filling materials? Properties, limitations and
future trends. Materials 2010;3: 76-96
18. Cardoso M V, Yoshida Y, van Meerbeek B. Adhesion to tooth enamel and dentin – a view on the latest
technology and future perspectives. Chapter 3 in: Roulet J-F, Kappert H F. Statements: Diagnostics
and therapy in dental medicine today and in the future. 2009. Quintessence
19. Moszner N, Fischer U K, Angermann J, Rheinberger V. A partially aromatic urethane dimethacrylate
as a new substitute for Bis-GMA in restorative composites. Dental Materials 2008; 24: 694-699
20. Featherstone J D B. Prevention and reversal of dental caries: role of low level fluoride. Community
Dent Oral Epidemiology 1999; 27: 31-40
21. Zero DT, Raubertas RF, Fu J, Pederson AM, Hayes AL, Featherstone JCB. Fluoride concentrations in
plaque, whole saliva, and ductal saliva after application of home-use topical fluorides. J. Dent Res
1992; 71 (11): 1768-1775
22. Fischer C, Lussi A, Hotz P. Kariostatische Wirkungsmechanismen der Fluoride. Eine Übersicht.
Schweiz Monatsschr Zahnmed. 1995; 105 (3): 311-317

23. Borges FT, Campos WR, Munari LS, Moreira AN, Paiva SM, Magalhães CS. Cariostatic effect of
fluoride-containing restorative materials associated with fluoride gels on root dentin. J Appl Oral Sci.
2010 Sep-Oct;18(5):453-60
24. Balzar Ekenbäck S, Lars Linder E, Sund EM, Lönnies H. Effect of fluoride on glucose incorporation
and metabolism in biofilm cells of Streptococcus mutans. Eur J Oral Sci. 2001; 109: 182-186
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69: 676-681
26. Schenck L, Burtscher P, Vogel K, Weinhold H-C. Major breakthrough in the field of direct posterior
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27. Burtscher P, Rheinberger V. Germanium based photoinitiator as an alternative to
camphorquinone/amine. IADR abstract 2008; 1611
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visible light photoinitiators for dental materials. Dent Mater. 2008. Jul 24 (7) 901-7
29. Moszner N. State of the art: Photopolymerization in dentistry. Ivocerin – a milestone in composite
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30. Burtscher P. Visible light curing of composite resin. In : Ivoclar Vivadent Report No. 18 2007,
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Contents: Joanna-C. Todd

Issued: October 2016

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3. Technical Data ............................................................................................................... 19

4. Materials Science Investigations / In Vitro ................................................................... 20

5. Clinical Investigations with Cention N ......................................................................... 51

Scientific Documentation: Cention N Page 2 of 58

1.1 Basic filling materials

1.1.1 Amalgam restoratives

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Proven clinical longevity Mercury content: biocompatibility /environmental burden

1.1.2 Glass Ionomer Cement restoratives

2 R-COOH + Ca(OH)2  R-COO- Ca2+ -OOC-R + 2 H2O

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Fluoride ion release Poor mechanical properties / Limited indication range

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Fig. 2: Cention N basic filling material in Powder/Liquid format

2.2 Resin/Monomer technology

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Polyethylene glycol 400

Table 3: Structural formulae of monomers used in Cention N

Scientific Documentation: Cention N Page 8 of 58

Barium aluminium silicate glass Ytterbium trifluoride

Fig. 4: Barium aluminium silicate glass Fig. 5: Ytterbium trifluoride

Isofiller Calcium barium aluminium fluorosilicate glass

Calcium fluorosilicate glass

Fig. 8: Calcium fluorosilicate glass

Scientific Documentation: Cention N Page 9 of 58

Barium aluminium silicate glass Strength

Ytterbium trifluoride Radiopacity

Isofiller Shrinkage stress relief

Calcium fluoro silicate glass Ion release F-, OH-, Ca2+

2.3.1 Ion release

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Scientific Documentation: Cention N Page 11 of 58

Fig. 10: Shrinkage stress reliever used in Cention N

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2.4 Polymerization Technology

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Fig. 12: Self-cure mechanism of Cention N: Radical formation

Fig. 13: Mechanism of the redox catalysis with Cu-ions

2.4.2 Light-cure (dual-cure) mechanism

Like most standard initiators used in dental materials,

Scientific Documentation: Cention N Page 14 of 58

Fig.15: Light-cure mechanism of Cention N with Ivocerin

Ivocerin bis(2, 4, 6-trimethylbenzoyl) phenylphosphine oxide

Scientific Documentation: Cention N Page 15 of 58

Fig. 17: Chemical formula of acyl

2.4.3 Light insensitivity

2.5 Cention N: Clinical appearance

Scientific Documentation: Cention N Page 16 of 58

The material’s translucency however, creates no drawback regarding coverage of discoloured

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Amalgam GIC Cention N

Preparation Capsule Hand Mix / Capsule Hand Mix

Amalgam GIC Cention N

Scientific Documentation: Cention N Page 18 of 58

Cention N Dual-curing restorative material

Function Substance/Component Weight (%)

Calcium fluorosilicate glass 25 - 35

Ba-Al silicate glass 20 - 30

Filler Ca-Ba-Al fluorosilicate glass 10 - 20 ---

Monomer Dimethacrylate --- 95 - 97

Additive Additive --- 1-2