A COMPARATIVE ASSESSMENT OF BRACKET BOND FAILURE RATE

OF TWO SELF-ETCHING PRIMERS

– An in vivo study

Dissertation submitted to

THE TAMILNADU DR. M.G.R.MEDICAL UNIVERSITY

In partial fulfillment for the degree of

MASTER OF DENTAL SURGERY

BRANCH V – ORTHODONTICS

MARCH - 2010

1
 CERTIFICATE

This is to certify that this dissertation titled “A COMPARATIVE ASSESSMENT

OF BRACKET BOND FAILURE RATE OF TWO SELF-ETCHING
PRIMERS-AN IN VIVO STUDY” is a bonafide record of work done by
Dr. SAM THOMAS K. under my guidance during his postgraduate study period
between 2007–2010.

This dissertation is submitted to THE TAMIL NADU Dr. M.G.R.

MEDICAL UNIVERSITY, in partial fulfillment for the degree of Master of Dental
Surgery in Branch V – Orthodontia.

It has not been submitted (partially or fully) for the award of any other degree
or diploma.

H. O. D & Guide Principal

Dr. N.R. Krishnas wamy M.D.S. Dr. S. Ramachandran M.D.S.

M.Ortho R.C.S. (Edin) Ragas Dental College & Hospital
Dip N.B. (Ortho) Chennai
Professor& Head
Department of Orthodontics
Ragas Dental College and Hospital
Chennai.

2
 Acknowledgement

It is a pleasure to express my gratitude to all, who have enlightened me and

helped me through the completion of this thesis.

I am indebted to my respected and beloved professor and guide, Dr. N.R.

KRISHNASWAMY, M.D.S., M.Ortho RCS. (Edin), Diplomat of Indian board of
Orthodontics, Professor and Head, Department of Orthodontics, Ragas Dental
College and Hospital, Chennai. He has always been a great source of inspiration and
I am grateful to him for his most valuable guidance and support. It is quite an honor
to study under such an icon and no student can ask for more. I am very thankful to
him for taking time from his busy schedule many a times to share his wisdom and
experience.

My sincere thanks to my Professors Dr. S. VENKATESWARAN,M.D.S. &

Dr. ASHWIN GEORGE, M.D.S, for their constant source of encouragement and
invaluable suggestions which has helped me see through my thesis with ease. I want
to take this opportunity to acknowledge and thank them for their support
throughout my post graduation.

My sincere thanks to Professor Mr. KANAKARAJ Chairman &

Dr. RAMACHANDRAN, Principal, Ragas Dental College for providing me with
an opportunity to utilize the facilities available in this institution in order to
conduct this study.

I greatly acknowledge Dr. JAYAKUMAR (Reader), Dr. ANAND

(Reader), Dr. SHAHUL, Dr. SHAKEEL, Dr. RAJAN and Dr. SHOBANA for
their support, enthusiasm & professional assistance throughout my post graduate
course.

3
 My heartfelt thanks to my wonderful batch mates, Dr.Biju Tom,
Dr.Chintan Valia, Dr.Prabhu, Dr.Rajkumar, Dr.Preethy, Dr.Kartik Mani, and
Dr. Kaberi who were cheerfully available at all times to help me. I wish them a
successful career ahead.

I also extend my gratitude to my juniors Dr. Kavitha, Dr. Subu Thomas, Dr.
Fayaz, Dr. Ritika, Dr. Amey, Dr. Vashi, Dr. Goutham, Dr. Geetha, Dr. Ashwin,
Dr. Ayush, Dr. Sheel, Dr. Sreesan, Dr. Vinod, Dr. Saravanan, Dr. Sabitha and Dr.
Mahalaxmi for all their support and for cooperating with me to conduct this study
on their patients.

I thank Mrs. DEEPA, for helping me with the statistical analysis for the
study.

My thanks to MR. ASHOK, and MR. RAJENDRAN & MR.KAMARAJ for

helping me with the technical work and the photographs for the study.

I would like to thank Sisters Lakshmi & Rathi & Mrs. Marina, Kanaka,
Azeena, Ms. Sreedevi & MR. SATHYAN for their co-operation and help during my
post-graduate course.

Words cannot express my gratitude to MY PARENTS who have showered

their love, blessings, understanding and support and borne many sacrifices to make
me who I am today. I would like to dedicate this work to my parents, who
encouraged me to pursue my career in dentistry.

I also thank My SISTER and BROTHER-IN-LAW and my two adorable

nephews for their constant love, support and encouragement.

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 CONTENTS

Title Page Number

1. Introduction 1

2. Review of Literature 6

3. Materials and Methods 33

4. Results 37

5. Discussion 41

5. Summary and Conclusion 54

6. Bibliography 56

5
 Introduction

6
 INTRODUCTION

Since the advent of the acid etch technique by Buonocore 10 and the

bonding of orthodontic brackets by Newman34 in 1965, bonding research

has strived to improve the delivery of orthodontic treatment. Orthodontic

bonding gave rise to significant improvements in treatment such as

greater patient comfort, elimination of the need for pretreatment tooth

separation, improved oral hygiene and esthetics, and reduced chair time.

Two areas of clinical improvement related to direct bonding are reducing

the number of steps for bonding procedures and minimizing the incidence

of enamel/bracket bond failures during treatment.

Buonocore 10 in 1955 first introduced direct bonding to the dental

profession as a way to increase retention for pit and fissure acrylics. He

used 85% phosphoric acid to etch enamel to improve retention.

Conventional bonding of orthodontic brackets with filled diacrylate

adhesives involves 4 distinct stages. First, the enamel surface is polished

with a slurry of pumice in water with a slow speed hand piece. It is then

conditioned with 37% o-phosphoric acid for 15 to 30 seconds, followed

by washing with water and air drying with oil-free compressed air until

the enamel is frosty white. Finally, an enamel primer (resin sealant) is

painted on the etched enamel, the bracket is placed on the tooth, and the

adhesive is cured.

7
 Recent advances in dental bonding chemistry allow the

combination of the etchant and primer into one product called a self-etch

primer (SEP) composed of methacrylated phosphoric acid esters. In the

1990s, self-etch primer was introduced to orthodontics as a way to save

chair time during bonding. Questions about resultant bond strengths have

been raised and studied both in vitro and in vivo.

These self etching agents are 6th generation bonding agents that

were developed to eliminate the conditioning, rinsing and drying steps,

that may prove to be critical and difficult to standardize in operative

conditions because of the instability of demineralized matrix. This single

step in bonding results not only in improvement in both time and

effectiveness to the clinician but also indirectly to the patient.

If the bond failure rates of SEPs are comparable with conventional

2-step etching and priming, then the reduced chair time should make the

self-etching primers more cost-effective. Several studies reported similar

bond failure rates between conventionally bonded brackets and those

bonded with SEPs.

SEPs were recently reported to save 10.2 seconds per tooth, for a

total of 204 seconds (3.4 minutes) when bonding 20 teeth. The benefits of

fewer bonding steps and less chair time should be weighed against the

increased cost of SEPs.

8
 In vitro studies have shown that bond strength produced by Self

Etching Primer is generally clinically acceptable but somewhat lower

when compared to the 3-step procedure. Adequate clinical bond strengths

in orthodontics range from 5.9 to 7.9 MPa as reported by Reynolds and

van Fraunhofer50. For example, Bishara 7 et al concluded that the use of

Self Etching Primer to bond orthodontic brackets to the enamel surface

resulted in lower (P = .004), but clinically acceptable, shear bond strength

(7.1 ± 4.4 MPa).

To obtain clinically acceptable bond strengths, it has traditionally

been necessary to prepare the enamel surface by first removing the

acquired organic pellicle through the use of pumice applied with a rubber

cup or brush. This pretreatment removes organic material including the

acquired pellicle.

Ireland et al24, evaluated Transbond Plus Self etching primer vs

conventional etch but disregarded the pumice prophylaxis step for all

groups. They found significantly more bond failures in the Self etching

primer group. Self etching primer has been shown to produce a weaker

bond than conventional etch methods in vitro, so pumice pretreat ment

might be necessary to ensure a cleaner enamel surface for maximum

efficacy of Self etching primer clinically.

9
 A commonly studied SEP is Transbond Plus (3M Unitek,

Monrovia, Calif), which has been shown to provide clinically acceptable

bond strengths when used with Transbond XT adhesive. This system uses

2 liquids that must be mixed before use. Transbond Plus SEP contains

methacrylated phosphoric acid esters with no volatile organic solvent and

a pH of 1.0. The calcium in the enamel is dissolved and removed from

hydroxylapatite by the phosphate group of the methacrylated phosphoric

acid ester. Instead of rinsing the calcium away, it forms a complex with

the phosphate group that is incorporated into the network when the

primer polymerizes. Three processes serve to stop the etching process on

enamel. First, the acid groups attached to the etching monomer are

neutralized by forming a complex with calcium from the hydroxlapatite.

Second, the air burst drives the solvent from the primer, increasing the

viscosity and slowing the transport of acid groups to the enamel surface.

Finally, as the primer is light cured and the monomers are polymerized,

the transport of acid groups to the enamel surface is stopped.

A SEP introduced in the market recently is the Reliance SEP

(Reliance Orthodontic Products, Itasca, IL) which is a one step self

etching primer, intended to be used for the preparation of a tooth surface

prior to bonding an orthodontic appliance(s) with a light cure adhesive.

The Reliance SEP is contained in a cartridge, which has to be

inserted into a hand held dispenser. Upon manual compression into a light

10
impervious mixing well, enough solution is dispensed to prepare the

enamel surface of up to 20 teeth.

No previous in-vitro studies, to our knowledge, have compared the

efficacy of the Reliance SEP with the conventionally used self etching

primers.

The purpose of this study is to comparatively assess the clinical

bracket bond failure rate of the Transbond Plus SEP with the Reliance

SEP during the leveling and aligning stage of treatment in twenty

patients.

11
Review of Literature

12
 REVIEW OF LITERATURE

SELF ETCHING PRIMER

Newman G.V. (1965)34 introduced the direct bonding technique by

combining acid etching with epoxy resin for bonding orthodontic

brackets.

Artun.J, Bergland.S. (1984)4 compared the bond strength of

conventional resin after conditioning the enamel surface with 37%

phosphoric acid and crystal growth conditioning with polyacrylic acid

and found that polyacrylic acid has less bond strength.

Van Meerbeek, S. Inokoshi, M. Braem, P. Lambrechts and G.

Vanherle (1992)63 in their study showed that the application of recent

adhesive systems induced structural changes in the dentin surface

morphology, creating a retentive interface, called the inter-diffusion zone,

between the deep, untouched dentin layers and the composite filling

material. This resin-dentin inter diffusion zone offers bonding sites for

copolymerization with the resin composite and, concurrently, might have

protective potential for the pulp tissues.

Watanabe, N. Nakabayashi and D. H. Pashley (1994)66 used

increasingly higher concentrations of Phenyl-P in 30% HEMA as dentin

conditioners to improve the bonding of adhesive resins to smear layers

13
and the maximum bond strength (10.4 MPa) was obtained at a

concentration of 20% Phenyl-P. They concluded that the single-step

conditioner/primer offers several advantages over previous bonding

systems by permitting a single solution to serve as both a conditioner and

a primer.

N. Nakabayashi and Y. Saimi (1996)33 used an aqueous solution of 20%

2-methacryloyloxyethyl phenyl phosphoric acid (phenyl-P) and 30% 2-

hydroxyethyl methacrylate, referred to as 2OP-30H, a "self-etching

primer". The 20P-30H solution was applied to "intact" dentin (i.e., non-

demineralized) for either 30 or 60 s. Control samples received no

application (O s) of the self-etching primer. Mean tensile bond strengths

(10 MPa) were similar in both the 30-second- and 60-second-primed

groups. SEM and TEM observations revealed that the 20P-30H self-

etching primer created diffusion channels into "intact" calcium-rich dentin

which permitted monomer to infiltrate dentin substrates, suggesting that

the hybrid layer was not defective, and that bonding was stable.

Perdigão J, Lopes L, Lambrechts P, Leitão J, Van Meerbeek B,

Vanherle G (1997)47, evaluated the enamel shear bond strengths and

compared the SEM interfacial morphology. The bonding surfaces were

treated with Clearfil Liner Bond 2 and the mean shear bond strengths

were in the range of 18.1 MPa to 25.9 MPa, and they use of alternative

14
etchants resulted in the deepest etching patterns. Regardless of the

alternative etchant used, the use of the self-etching primer did not affect

the mean enamel shear bond strength.

Nikaido T, Nakajima M, Higashi T, Kanemura N, Pereira PN,

Tagami J.(1997)35 evaluated the efficacy of single-step bonding system

on adhesion of resin-modified GICs and resin composite to enamel and

dentin by shear bond test and SEM observation. Good bond strengths to

enamel were obtained (> 11 MPa), whereas significantly low bond

strengths to dentin were obtained using a single coat of the primer.

However, double-coating improved the bond strengths to dentin (> 8

MPa). These findings suggested that good adhesion to enamel and dentin

could be achieved using a single-step bonding system.

Hannig M, Reinhardt KJ, Bott B.(1999)21 ,investigated the composite-

to-enamel bond strength and analyzed the marginal adaptation of resin

composite restorations in class 2 cavities using three self-etching priming

agents in comparison to conventional phosphoric acid etching and

bonding application. Clearfil Liner Bond 2/Clearfil AP-X (Group I), Etch

& Prime 3.0/Degufill mineral (Group II), Resulcin AquaPrime +

MonoBond/Ecusit (Group III). In Group IV Ecusit-Mono/Ecusit was used

after enamel etching with phosphoric acid (37%). ANOVA revealed

significant (P < 0.05) differences in shear bond strength between groups,

15
except comparison of Group I and II, and Group I and IV. The results

indicated that use of self-etching primers may be an alternative to

conventional phosphoric acid pre-treatment in composite-to-enamel

bonding restorative techniques.

Rosa BT, Perdigão J.(2000)51 , determined the enamel and dentin bond

strengths of a non-rinsing "all-in-one" adhesive and of a non-rinsing

conditioner combined with a 1-bottle adhesive. They concluded that the

Compomer and resin composite exhibited statistically similar bond

strengths. Bond strengths to dentin were significantly lower than those to

enamel.

M. Miyazaki M. Sato H. Onose (2000)31 , determined the effect of

thermal cycling on the enamel bond strengths of two-step adhesive

systems, either self-etching primers or "one-bottle" total-etch systems.

They concluded that enamel shear bond strengths after thermal cycling of

self-etching primer systems appeared to be less stable than were those of

total-etch adhesive systems.

P. Sencer, Y. Wang, P. Walker M and R. Swafford J (2001) 48,

determined the molecular structure of acid-etched carbide- and diamond-

bur-created smear layers and smear layer/demineralized/mineralized

dentin interfaces were analyzed at 1- m intervals by micro-Raman

spectroscopy. They concluded that the disorganized collagen within the

16
smear layer was not removed but was denatured by the acid treatment; the

mineral was trapped in this gelatinous matrix and shielded from complete

reaction.

Ulrike B. Fritz, Peter Diedrich, Werner J. Finger (2001) 62, evaluated

the bonding capacity of three self-etching primers (Clearfil™ SE Bond

[SE], Clearfil™ Linder Bond 2V [CLB], Novabond ® [NOVA]) to

enamel. Two adhesive systems with a separate phosphoric acid etching

procedure (Gluma® Comfort Bond GLU], Kurasper F (KURARAY)

served as controls. 60 human incisors were used. Significant differences

were found between the groups (p < 0.001). The mean value for groups,

GLU, KU, CLB and SE was 24 MPa. The shear bond strength recorded

for the Novabond ® system was significantly lower (17 MPa).They

concluded that enamel bonding especially with the self-etching primers

CLB and SE is effective as conventional phosphoric acid etching.

Pashley DH, Tay FR (2001)44, investigated the aggressiveness of three

self-etching adhesives on unground enamel and the results showed

etching patterns of aprismatic enamel, as revealed by SEM and TEM,

varied according to the aggressiveness of the self-etching adhesives.

Clearfil Mega Bond exhibited the mildest etching patterns, while Prompt

L-Pop produced an etching effect that approached that of the total-etch

control group. When the self-etching adhesives were replaced with the

17
control adhesive after etching, bond strengths of NRC/Prime&Bond NT

and Prompt L-Pop were not significantly different from that of the control

group, but were significantly higher than that of Clearfil Mega Bond. The

significance is that both etching efficacy and strength of the resins are

important contributing factors in bonding of self-etching adhesives to

unground enamel.

Bishara et al (2001)6, conducted a study to determine the effects of the

use of a self-etch primer on the shear bond strength of orthodontic

brackets and on the bracket/adhesive failure mode. The results showed

that the use of a self-etch primer resulted in a significantly lower, but

clinically acceptable, shear bond force as compared with the control

group. The adhesive remnant index scores indicated that there was

significantly more residual adhesive remaining on the teeth treated with

the new self-etch primer than those treated with the conventional

adhesive system.

Matthias Hannig , Henning Bock , Burkard Bott , Wiebke Hoth-

Hannig (2002)29,analysed the mode of action of self-etching adhesive

systems when applied for resin-to-enamel bonding. TEM was used to

investigate the enamel–resin interface after application of non-rinsing

self-etching adhesive systems based on phosphoric acid estered

methacrylates (Clearfil Liner Bond 2, Clearfil SE Bond, Etch & Prime 3.0

18
and Resulcin AquaPrime) compared with conventional phosphoric acid

etching and bonding (Heliobond). Non-decalcified ultrathin sections from

the interface between enamel and self-etching adhesive systems revealed

a 1.5–3.2-µm deep enamel surface layer characterized by a less-dense

arrangement of enamel crystallites separated from each other by

nanometer-sized spaces, indicating that self-etching priming agents

dissolve the peripheral and central part of the enamel crystallites, while

simultaneously promoting inter- and intra-crystallite monomer

infiltration. A similar pattern, but greater depth (6.9 µm) of enamel

surface hybridization was found in the phosphoric acid-etched and

bonded specimens. The nano retentive interlocking between enamel

crystallites and resin could explain the potential of self-etching adhesive

systems in resin-to-enamel bonding despite the less distinct enamel

etching pattern observed in scanning electron microscopy investigations.

Rieko Yamada, Tohru Hayakawa, Kazutaka Kasai (2002) 49

determined the shear bond strengths of orthodontic brackets bonded with

one of four protocols: (1) a composite resin adhesive used with 40%

phosphoric acid, (2) the same composite resin used with Megabond self-

etching primer, (3) a resin-modified glass ionomer cement adhesive used

with 10% polyacrylic acid enamel conditioner, and (4) the same resin-

modified glass ionomer cement used with Megabond self-etching primer.

19
They concluded that Megabond self-etching primer treatment produced

less enamel dissolution than did etching with phosphoric acid and

polyacrylic acids. The study's findings provide evidence that Megabond

self-etching primer is a candidate for bonding orthodontic brackets using

the resin-modified glass ionomer cement, with the advantage of

minimizing the amount of enamel loss.

Ryan W. Arnold, Edward C. Combe, John H. Warford Jr (2002) 52

measured the shear bond strength of stainless steel brackets bonded to

enamel in vitro with the Transbond Plus Self Etching Primer. Forty-eight

extracted human teeth were obtained and randomly divided into 4 groups

of 12: (1) control group with a conventional etchant and separate primer,

(2) experimental group with the self-etching primer, left for 15 seconds

before bonding, (3) same as group 2, but with the primer left for 2

minutes before bonding, (4) same as group 2, but with the primer left for

10 minutes before bonding. They concluded that there was no significant

difference in the bond strength between the 4 groups as determined by

analysis of variance (ANOVA) (P < .05). Under the conditions of

these experiments, a 10-minute delay in bonding after application of the

self-etching primer might not be deleterious to adhesion.

Perdigão J, Geraldeli S.(2003)46, tested that the preparation of the

enamel surface would not affect the enamel microtensile bond strengths

20
of self-etching adhesive materials and concluded that commercial self-

etching adhesives performed better on prepared enamel than on

unprepared enamel. The field-emission scanning electron microscope

revealed a deep interprismatic etching pattern for the total-etch adhesive,

whereas the self-etching systems resulted in an etching pattern ranging

from absent to moderate.

Aljubouri and Gilmour (2003)2, carried out a study to compare the

mean bonding time, mean shear bond strength and mean survival time of

stainless steel brackets with a micro-etched base bonded with a light-cure

composite using a self-etching primer (SEP) or a conventional two-stage

etch and prime system. The SEP significantly reduced bracket bonding

time. The mean shear bond strength of the brackets bonded with the SEP

was significantly less than the conventional two-stage etch and prime

system. There was no difference in survival time of brackets bonded by

each bonding system.

Oonsombat C, Bishara SE, Ajlouni R (2003)38, assessed the effect of

blood contamination on the shear bond strength of orthodontic brackets

with a new self-etch primer. The results of the analysis of variance (F =

13.31) indicated that the shear bond strengths of the 4 groups were

significantly different (P =.001).They concluded that blood contamination

at any stage of the bonding procedure results in a significant and drastic

21
drop in the shear bond strength of orthodontic brackets.

Oliveira SS, Pugach MK, Hilton JF, Watanabe LG, Marshall SJ,

Marshall GW Jr. (2003)37 determined the effect of dentin smear layers

created by various abrasives on the adhesion of a self-etching primer (SE)

and total-etch (SB) bonding systems. Results showed SBS was lower

when SB was used than when SE was used. SBS decreased with

increasing coarseness of the abrasive in the SE group. They concluded

that even though SBS was affected by different surface preparation

methods, SE yielded higher SBS than SB.

Vittorio Cacciafesta, Maria Francesca Sfondrini, Marco De Angelis,

Andrea Scribante, Catherine Klersy (2003)11 assessed the effect of

water and saliva contamination on the shear bond strength and bond

failure site of 3 different orthodontic primers (Transbond XT, Transbond

Moisture Insensitive Primer, and Transbond Plus Self Etching Primer;

3M Unitek, Monrovia, Calif) used with a light-cured composite resin

(Transbond XT). They concluded that the self-etching primer was the

least influenced by water and saliva contamination, except when

moistening occurred after the recommended 3-second air burst. No

significant differences in debond locations were found among the groups

bonded with the self-etching primer under the various enamel conditions.

22
Anthony J. Ireland, Helen Knight, Martyn Sherriff, (2003) 24

investigated the in vivo bond failure of Transbond adhesive precoated

brackets after using either the Transbond Plus Self- Etching Primer

system or a conventional acid etching, rinsing, drying, and priming

regimen. They concluded that enamel pretreatment with the Transbond

Plus Self-Etching Primer system before orthodontic bonding is likely to

result in a higher bond failure rate than conventional enamel acid etching

and priming.

Mayuko Kawasaki, Tohru Hayakawa, Tsutomu Takizawa, Somsak

Sirirungrojying, Kayo Saitoh, Kazutaka Kasai (2003) 25 determined the

effects of the new MMA-based resin cement with a self-etching primer

Multibond on the shear bond strength of orthodontic brackets as

compared with the shear bond strength of orthodontic brackets bonded

with Superbond C&B. They concluded that the MMA-based resin cement

with self-etching primer Multibond has a potential for clinical use in

bonding metal or plastic orthodontic brackets to teeth, with the advantage

of minimizing the amount of enamel loss and reducing the number of

clinical steps during bonding.

Erhardt MC, Cavalcante LM, Pimenta LA (2004)19, evaluated the

influence of phosphoric acid pretreatment on shear bond strength of two

self-etching bonding systems to enamel and dentin. They concluded that

23
enamel etching with 37% phosphoric acid provided statistically

significant higher shear bond strength values, regardless of the adhesive

system. However, in dentin, for Clearfil Liner Bond 2V, phosphoric acid

pretreatment negatively affected bond strength values.

Bishara SE, Oonsombat C, Ajlouni R, Laffoon F.(2004) 7 assessed and

compared the effects of mix and no-mix self-etch primers/bonding

systems on the shear bond strengths of orthodontic brackets. The mean

shear bond strength of the 2-component acid etch primer was 5.9 +/- 2.7

MPa, and the mean for the 1-component system was 6.6 +/- 3.2 MPa.

They concluded that the clinician should consider the bond strength and

the ease of application of the various components of the bracket bonding

systems.

Somsak Sirirungrojying, Kayo Saito, Tohru Hayakawa, Kazutaka

Kasai (2004)55 evaluated the effectiveness of using a self-etching primer

with Superbond C&B resin cement to bond orthodontic brackets to

human enamel and investigated the influence of saliva contamination on

shear bond strength of orthodontic brackets bonded with Superbond C&B

cement to self-etch primed and acid-etched human enamel surfaces. They

concluded that Megabond is a better candidate than phosphoric acid

etchant for preparing the enamel surface and the use of Megabond saves

water-rinsing time and leads to less enamel surface loss when debonding.

24
In addition, saliva contamination does not affect the bond strength, and

repeat treatment with the self-etching primer is not necessary after saliva

contamination.

Y. D. Aljubouri, D. T. Millett, W. H. Gilmour (2004)3 compared the

mean clinical chair-side time required for bracket bonding and the mean

bond failure rate at 6 and 12 months of stainless steel brackets with a

micro-etched base bonded with a light-cured composite using a self-

etching primer (SEP) or a two-stage etch and prime system. They

concluded that the mean bracket bonding time with the SEP per patient

was significantly shorter than that of the two-stage bonding system (P <

0.001). The difference between the overall bond failure rate and the mean

bond failure rate per patient for the two bonding systems was not

statistically or clinically significant at 6 and 12 months.

Todd Kimura, William J. Dunn, Louis J. Taloumis (2004)26

investigated the relationship between the shear bond strength of

orthodontic brackets to enamel, with or without fluoride varnish, by using

either conventional or self-etching primer systems. Forty-eight extracted

teeth were divided into 4 groups of 12 teeth each: group 1, fluoride

varnish, conventional adhesive; group 2, fluoride varnish, self-etching

primer system; group 3, no fluoride varnish, conventional adhesive; and

group 4, no fluoride varnish, self-etching primer system. They concluded

that the application of fluoride varnish does not affect the bond strength

25
of orthodontic brackets to enamel with conventional or self-etching

primer systems.

Brian Trites, Timothy F. Foley, David Banting (2004)58 evaluated the

shear-peel bond strength of 2 SEP with their respective adhesives

compared with a control composite bonding system. Shear-peel bond

strengths and adhesive failure locations were compared at 3 storage

intervals: 24 hours, 30 days, and 3 months. They concluded that the

lowest mean shear-peel bond strength values were noted at the 30-day

storage. Bond failure analysis (adhesive remnant index) demonstrated

mainly cohesive bond failures.

M Dolores Campoy; Ascensio´n Vicente; Luis Alberto Bravo (2005)15

evaluated the effect of saliva contamination at different stages of the

bonding brackets procedure using the self-etching primer Adper Prompt

L-Pop and the resin orthodontic adhesive system Transbond XT. Their

results suggested that contamination after photo-curing

of SEPs has a lesser influence on the reduction of the shear bond strength

than contamination before priming.

Nikolaos Pandis and Theodore Eliades (2005) 40 assessed the clinical

failure rate of 2 SEPs (Transbond Plus Self Etching Primer and One Step

Self-Etching Primer) over 14 months of treatment. The overall total

failure rates were 0.94%, for Transbond Plus

26
and 8.10% for One-Step. Although significantly more failures were found

for the mandibular arch, no difference was identified in failure rate

between anterior and posterior teeth.

Nikolaos Pandis; Lars Christensen; Theodore Eliades (2005)41

assessed the long-term in vivo failure rate of tubes bonded to first and

second molars with a self-etching primer. They concluded that self-

etching primer may be effectively applied to bonding first-molar tubes,

whereas further research is necessary to verify their effectiveness in

second molars, especially in the mandible.

Cehreli ZC, Kecik D, Kocadereli I.(2005)17, compared the shear bond

strength of 4 self-etching primer and adhesive formulations, a nonrinse

conditioner and acetone adhesive system, and a conventional system. The

results showed that shear bond strengths of the 5 experimental groups

were all significantly lower (P < .05) than that of the control group

(Prompt L-Pop, 1.72 +/- 0.13 MPa; Clearfil SE Bond, 1.75 +/- 0.19 MPa;

FL Bond, 1.71 +/- 0.22 MPa; One-Up Bond F, 1.77 +/- 0.14 MPa;

control, 10.5 +/- 0.86 MPa) but not different from one another (P > .05).

They concluded that tested self-etching primer and adhesive systems

produced bond strength values much lower than the control and that

clinically, these products might not be suitable for orthodontic bracket

27
bonding in terms of the shear bond strength achieved after thermal

cycling and water storage.

Julio P. Cal-Neto; Jose´ Augusto M. Miguel (2006)12 analyzed the

effect of a self-etching primer (Transbond Plus SEP), in the regularity and

depth of adhesive infiltration in the enamel of human permanent teeth and

to compare it with phosphoric acid using scanning electron microscopy.

They concluded that the SEP was more conservative and produced a

smaller amount of demineralization and less penetration of adhesive in

the enamel surfaces when compared with the conventional phosphoric

acid system.

Sunil Hirani and Martyn Sherriff (2006)23 compared the shear bond

and rebond strengths and failure sites of Adhesive Precoated Brackets

(APC 1 and APC 2) with a non-coated bracket system [Victory Series

(V)] using Transbond XT light-cured adhesive and Transbond Plus SEP

or 37 per cent phosphoric acid as the conditioner. They found the shear

rebond strengths of all bracket types were statistically significantly lower

( P < 0.05) than their initial SBS and the locus of bond failure altered

from the adhesive – enamel interface to the bracket – adhesive interface.

N. Manning; S. M. Chadwick; D. Plunkett; T. V. Macfarlane (2006) 28

assessed the clinical bond failure rates of orthodontic brackets bonded

using a self-etching primer (SEP), compared with brackets bonded using

28
a conventional acid-etched technique with control adhesive (Transbond).

They concluded that there was no statistically significant difference

between the clinical bond failure rates for brackets bonded using a self-

etching primer or a conventional acid-etch and resin technique.

P. G. Murfitt , A. N. Quick , M. V. Swain and G. P. Herbison (2006)32

conducted a clinical trial to evaluate the performance of brackets bonded

to teeth etched and primed with Transbond ™ Plus Self-Etching Primer

(SEP) when compared with a conventional separate two-step etch and

primer system. They concluded that Transbond ™ Plus SEP has a

significantly higher bond failure rate than the conventional separate 37

per cent phosphoric acid and primer method, and that the bond failure

mode was predominately at the enamel – adhesive interface for the

Transbond ™ Plus SEP.

Nikolaos Pandis; Argyro Polychronopoulou; Theodore Eliades

(2006)42 assessed the failure rate of self-ligating and edgewise brackets

bonded with a self-etching primer and conventional phosphoric acid in

patients followed for 12 months of active treatment. They found no

difference in failure incidence between self-ligating and edgewise

brackets bonded with conventional acid etching or SEP in the mandibular

or maxillary arches, whereas a statistically significant difference was

shown for right-sided appliances.

29
Julio Pedra e Cal-Neto; Felipe Carvalho; Rhita Cristina C. Almeida;

Jose´ Augusto M. Miguel (2006)13 evaluated the influence of a new self-

etching primer (Adper Prompt L-pop) on shear bond strength of

orthodontic brackets. They found no difference in bond strength whether

a conventional etching and primer or Adper Prompt Lpop is used. The

amount of adhesive on enamel after debonding was significantly less

when using Adper Prompt than when using phosphoric acid.

Bishara SE, Ajlouni R, Laffoon JF, Warren JJ.(2006)8 assessed and

compared the effects of using one-step and two-step self-etch

primer/adhesive systems on the shear bond strength of orthodontic

brackets. The mean shear bond strength of the two-step acid-etch

primer/adhesive was 5.9 +/- 2.7 Mpa and the mean for the one-step

system was 3.1 +/- 1.7 MPa. The results showed that the shear bond

strengths (t = 3.79) of the two adhesive systems were significantly

different (P = .001).They concluded that one-step adhesive systems could

potentially be advantageous for orthodontic purposes if their bond

strength can be improved.

Al-Nahedh H, Ateyah NZ.(2006)1 evaluated the effect of acidic

conditioning with phosphoric acid and Prompt L-Pop (PLP) on the shear

bond strength of two compomers Dyract AP (DAP) and Composan Glass

(CG) to dentin. They concluded that acid etching significantly increased

30
the shear bond strength of CG to dentin but did not affect DAP. The

application of PLP resulted in a shear bond strength not statistically

different from PBNT (Prime & Bond NT) or CPNE (Compobond NE).

Anthony Pasquale, Martin Weinstein, Alan J. Borislow, and

Leonard E. Braitman (2007)45 comparatively assess the bond failure

rates of orthodontic brackets bonded with 2 self-etching primer (SEP)

bonding systems; Transbond Plus SEP (3M Unitek) and Ideal 1 SEP

(GAC International) over an 18-month period. They concluded that the

Ideal 1 SEP bonding system had 3 times as many bracket failures as the

Transbond Plus SEP bonding system; and that clinicians should consider

the many associated costs of bracket failures (chair time, material costs)

when choosing bonding systems.

Tamer Turk; Selma Elekdag-Turk; Devrim Isci; Fethiye Cakmak;

Nurhat Ozkalayci (2007)60 evaluated the effect of saliva contamination

at different stages of the bonding procedure on the SBS of an SEP

(Transbond Plus) at different debond times of 5, 15, and 30 minutes and

24 hours. They concluded that the Transbond Plus SEP produces

clinically acceptable bracket bonding after 5, 15, and 30 minutes from

time of placement on the teeth, even with light and heavy saliva

contamination.

31
Ascensio´n Vicente; Luis Alberto Bravo (2007)64 tested the hypothesis

that there were no significant differences in the shear bond strength or the

adhesive remaining on the tooth after debonding between precoated and

uncoated brackets using a self-etching primer, Transbond Plus SEP. They

found that there was no significant difference in the bond strength of the

two systems tested, but there was a significant difference in the

percentage of area of adhesive remaining on the tooth.

Turk T, Elekdag-Turk S, Isci D.(2007)61 evaluated the effect of a self-

etching primer on shear bond strengths (SBS) at the different debond

times of 5, 15, 30, and 60 minutes and 24 hours. Highest SBS was

obtained with a debond time of 24 hours for the CM group (16.82 MPa)

and the SEP group (19.11 MPa) They concluded that adequate SBS was

obtained with self-etching primer during the first 60 minutes (5, 15, 30

and 60 minutes) when compared with the conventional method and that it

is reliable to load the bracket 5 minutes after bonding using self-etching

primer (Transbond Plus) with the light-cure adhesive (Transbond XT).

Selma Elekdag-Turk; Tamer Turkb; Devrim Iscic; Nurhat

Ozkalaycic (2008)53 determined the effects of thermocycling on shear

bond strengths (SBSs) of a self etching primer (SEP) after 0, 2000, and

5000 thermal cycles. In the control group (conventional method) teeth

were etched with 37% phosphoric acid. In the experimental group, an

32
SEP (Transbond Plus) was applied. In the control group, SBSs did not

show any significant differences among 0, 2000, and 5000 thermal

cycles. However, in group SEP, SBSs decreased with 2000 and 5000

thermal cycles, and these decreases were significantly different from no

thermocyling (P _ .001). They concluded that the SEP (Transbond Plus)

provides clinically acceptable bond strength values compared with the

conventional method after thermocycling.

Selma Elekdag-Turk , Devrim Isci , Tamer Turk and Fethiye

Cakmak (2008)54 compared the clinical performance of a self-etching

primer, Transbond Plus SEP with a conventional two-step etch and

primer [conventional method (CM)]. The chair time required for bonding

was also evaluated. The failure rates were 0.6 per cent for both bonding

procedures. The failure and survival rates did not show significant

differences between the bonding procedures, upper and lower dental

arches, or gender. However, premolar brackets displayed a higher bond

failure rate and a lower survival rate than incisor and canine brackets.

This finding indicates that SEP can be effectively used for bonding of

orthodontic brackets. Furthermore, the mean bracket bonding time with

SEP per tooth was significantly shorter than with the CM.

Daniel J. Lill, Steven J. Lindauer, Eser Tüfekçi, and Bhavna Shroff

(2008)27 assessed the importance of a pumice prophylaxis before bonding

33
in reducing bond failures. A split-mouth design was used; in each patient,

1 quadrant was randomly assigned to the pumice prophylaxis

experimental group and the contralateral quadrant to the nonpumice

group. A total of 508 teeth were bonded with SEP (Transbond Plus; 3M

Unitek) and monitored for 3 months for bond failures. Thirty-five failures

(6.9%) were recorded, with 6 (2.4%) in the pumice group and 29 (11.4%)

in the nonpumice group. A significantly lower and clinically acceptable

bond failure rate was demonstrated with Transbond Plus SEP after

pumice prophylaxis. This study produced strong evidence suggesting the

need for pumice prophylaxis when using SEP for orthodontic bonding.

Nihar Tanna, Elizabeth Kao, Marcia Gladwin, Peter W. Ngan

(2009)57 compared the resistance to enamel demineralization between

self-etching primer (SEP) and conventional sealant in vitro. A total of 120

molar sections were randomly assigned to 3 groups: SEP (Transbond

Plus, 3M Unitek), sealant (Light Bond fluoride-releasing sealant,

Reliance Orthodontic Products), or control (no enamel treatment). The

tooth samples were exposed to rotary brushing for 2 minutes. A 2 × 2-

mm window of sound enamel was created by using nail varnish. After 48

or 72 hours of acidic challenge with Ten Cate solution (pH 4.46), the

samples were sectioned down to a thickness of 200 μm and stained with

rhodomine B dye to evaluate les ions, lesion depths, area of lesions, and

total fluorescence by using confocal microscopy. The results showed the

34
incidence of lesion was 50% in the sealant group and 100% in both the

SEP and the control group. The lesion in the sealant group was present

only when the sealant integrity was broken. These results suggest that

neither sealant completely protects the teeth against enamel

decalcification. The application of sealant provided protection in 50% of

the samples, whereas the SEP provided no resistance to enamel

demineralization.

Matthew A. Ghiz, Peter Ngan, Elizabeth Kao, Chris Martin, Erdogan

Gunel (2009)20 compared the effects of a conventional etch and sealant

(CES) and the Transbond SEP (3M Unitek) on enamel decalcification in

vivo. Twenty-five patients who required comprehensive orthodontic

treatment were included in this study, and a split-arch technique was

used. Scanning electron microscopy images and x-ray spectrum analysis

were performed to examine the etched pattern of the 2 bonding systems.

The results showed significantly higher decalcification scores in the SEP

group (27.5%) compared with the CES group (13.9%). No significant

differences were found in the decalcification scores for teeth in the

maxillary and mandibular arches. Significant d ifferences were found

between level of hygiene and decalcification (P <0.0001). This study

concluded that using a SEP might save chair time and improve cost-

35
effectiveness, but it provides less resistance to enamel decalcification

than a CES, especially in patients with poor oral hygiene.

Rogelio J. Scougall-Vilchis, Shizue Ohashi, and Kohji Yamamoto

(2009)65 compared the effects of 6 self-etching primers (SEPs) on the

shear bond strength (SBS) of orthodontic brackets bonded with the same

orthodontic composite resin. One hundred forty extracted premolars were

randomly divided into 7 groups (20 per group). In group I (control), the

enamel was etched with 37% phosphoric acid. In the other groups, it was

conditioned with SEPs according to each manufacturer’s instructions:

group II, Transbond Plus SEP (3M Unitek); group III, AdheSE (Ivoclar

Vivadent AG); group IV, Primers A and B (Shofu, Kyoto, Japan); group

V, Clearfil Mega Bond FA (Kuraray Medical); group VI, Peak SE and

Peak LC Bond (Ultradent Products); and group VII, Bond Force

(Tokuyama, Osaka, Japan). All brackets were bonded with Transbond XT

(3M Unitek), and the teeth were then stored, tested, and statistically

analyzed. The adhesive remnant index (ARI) was also recorded. The

results showed that Group I had a significantly higher SBS value than the

other groups except group II. There were no significant differences

among groups II, V, VI, and VII. The values for groups I, II, and VI were

significantly higher than for group

36
III and the value for group IV was significantly lower than the values for

groups I, II, V, VI, and VII. Significant differences were found in the ARI

scores. This study concluded that the SBS values of all groups might be

clinically acceptable, and orthodontic brackets can be successfully

bonded with Transbond XT after enamel conditioning with any of these

SEPs. However, since the SEPs used in groups III and IV significantly

affected the bond strength negatively, further studies are warranted to

evaluate their effectiveness.

Ekaterini Paschos, Natascha Kurochkina, Karin C. Huth, Clara S.

Hansson, and Ingrid Rudzki-Janson (2009)43 compared the failure

rates of orthodontic brackets by using 2 self-etching primers (SEPs)

(Transbond Plus [3M Unitek] and Clearfil Protect Bond [Kuraray

Medical]) with a split-mouth design. A total of 480 brackets were bonded

in 24 patients with the SEPs. The observation period was 12 months. One

week after bonding and at every third recall, the plaque index and a visual

rating of the enamel adjacent to the bracket were assessed at the lateral

incisors and the first premolars. Over the investigation time, 26 failures

were recorded. Five occurred with the brackets bonded with Transbond

Plus, and the rest with Clearfil Protect Bond (P = 0.002). This study

concluded that the failure rate with Clearfil Protect Bond was

significantly higher when compared with the Transbond Plus SEP.

37
Julio Pedra e Cal-Neto, Catia Abdo Quintao, Marco Antonio de

Oliveira Almeida, and Jose´ Augusto Mendes Miguel (2009)14

evaluated over a 12-month period the performance of a self-etching

system (SEP) (Transbond Plus SEP, 3M Unitek) compared with a

conventional multi-step system (TBXT) (Transbond XT, 3M Unitek).

Twenty-eight randomly selected patients were included in this study.

They were randomly assigned to either the TBXT or the SEP group. A

total of 548 brackets were bonded according to the manufacturer’s

instructions with Transbond XT adhesive paste. Bracket survival

distributions for bonding procedure, tooth location, dental arch, and

patient sex were compared with the log-rank test. The failure rates of the

TBXT and SEP groups were 4.78% and 6.88%, respectively. No

significant differences in the survival rates were observed between the

bonding procedures (P = 0.311). When tooth location, dental arch, and

sex were analyzed, only tooth location was significant. Posterior brackets

were more likely to fail than anterior brackets (P = 0.013). The study

concluded that both systems had low bond failure rates and are adequate

for orthodontic bonding needs.

L. Evans, K.R. McGrory, J. English (2009)18 compared the bond

strength of three different Self Etching Primers - Transbond Plus Self-

etching Primer, Reliance Self-etching Primer, and GAC Ideal 1 Self-

38
etching Primer; and at how each responded when contaminated with

either saliva or water. They found that in five of the six groups that

compared the primers, Reliance SEP had the highest bond strengths.

However, for two of the groups, the measurements were not significantly

different than those of the conventional phosphoric acid etching system.

In all six groups, GAC Ideal 1 had the lowest bond strengths. They

concluded that both Transbond Plus Self-etching Primer and Reliance

Self-etching Primer had bond strengths similar to those of the control

group treated with phosphoric acid.

39
Materials and Methods

40
 MATERIALS AND METHODS

The materials and methodology used in this study are described below.

MATERIALS

1.Self Etching Primers:

a. Transbond Plus (3M Unitek, Monrovia, Calif) SEP

b. Reliance SEP (Reliance Orthodontic Products, Itasca, Ill)

2. Brackets:

Direct bond stainless steel pre-adjusted edgewise, Roth 0.022 slot

brackets with metallic foil-mesh backing (Mini-Ovation; Dentsply, GAC)

were used on all patients.

3. Adhesive:

TM
Transbond XT (Composite resin), a light-cured composite paste was

used. (3M Unitek, Monrovia, Calif).

4. Light Cure Kit:

TM
3M Ortholux XT curing light, visible light range – 400 to 500 nm,

light output power – 450 mw/cm2.

41
5. Other materials and armamentarium used were:

 Mouth mirror, Probe, Bracket Holder, Tweezer, Bracket Positioner.

 Light impervious mixing well.

 Plastic instruments and brushes.

 Compressed air/water facility with a 3-way syringe.

 Micro motor hand-piece with polishing cups and a slurry of

pumice.

 Suction unit.

METHODOLOGY

Twenty patients who came for orthodontic treatment to the Dept. of

Orthodontics, Ragas Dental College & Hospital, Chennai; were randomly

divided into two groups: Group A and Group B.

The randomization was done using a software available on the

internet (Quick Calcs, Graph Pad Software,

www.graphpad.com/quickcalcs). This software is seeded with the time of

day, so it generates a different result each time it is used. Each patient is

first assigned to a group non randomly. Then the assignment of each

subject is swapped with the group assignment of a randomly chosen

subject.

42
 All teeth were pumiced and rinsed, and extra care was taken to

remove any calculus. A split – mouth design was used. For each patient

the SEPs were used in alternating quadrants so that they were distributed

equally on the left and right sides. The SEPs were applied according to

the manufacturers' instructions.

Group A consisted of ten patients bonded with Transbond Plus

SEP (3M Unitek) on the maxillary right and the mandibular left

quadrants; and the Reliance SEP on the maxillary left and mandibular

right quadrants. Group B consisted of the remaining ten patients bonded

with the Reliance SEP on the maxillary right and mandibular left

quadrants and the Transbond Plus SEP on the maxillary left and

mandibular right quadrants. This totaled to 320 teeth being bonded; out of

which 160 teeth were bonded with the Transbond Plus SEP and the other

160 teeth with the Reliance SEP.

The inclusion criteria for all twenty patients were as follows:

 Complete permanent dentition.

 Treatment required maxillary and mandibular fixed appliances.

 No crowns, bridges, veneers or restorations anterior to the first

permanent molars.

43
  Patients requiring extraction for orthodontic treatment; provided

the extraction patterns are symmetrical to balance the number of

teeth in each bonding regimen.

 Similar projected mechanotherapies.

The initial archwire placed was 0.14 Nickel-Titanium wire, followed

by various combinations of round and rectangular

Nickel-Titanium and Stainless Steel wires as treatment progressed.

Recording of failed brackets involved only first time failures, and the

study was conducted till the leveling and aligning stage of treatment was

completed.

All patients that participated were informed in detail about the

study and were made to sign an informed consent form.

44
ARMAMENTARIUM USED IN THE STUDY

ORTHOLUX XT LIGHT CURING UNIT

45
TRANSBOND PLUS S.E.P.

RELIANCE S.E.P.

46
 Results

47
 RESULTS

This study was performed on twenty patients undergoing fixed

orthodontic therapy, over a span of the leveling and aligning stage of

treatment. Twenty patients were divided randomly into two groups,

Group A and Group B, of ten patients each. All patients had a pumice

prophylaxis done before the brackets were bonded. A total of 320

brackets were bonded using the Transbond Plus Self Etching Primer and

the Reliance Self Etching Primer, as follows:

Group A - Upper right and Lower left quadrants – Transbond Plus

Upper left and Lower right quadrants- Reliance SEP

Group B – Upper left and Lower right quadrants – Transbond Plus

Upper right and Lower left quadrants – Reliance SEP

This totaled to 160 brackets bonded with the Transbond Plus SEP and

another 160 brackets bonded with the Reliance SEP.

STATISTICAL TEST:

Chi – square test was used to determine significant differences in the

bracket bond failure rate, between the two groups, with a 5% level of

significance, using the SPSS v. 11.5.

48
 Table 1

No. OF
PRODUCT BRACKET FAILURE
P - VALUE
BOND PERCENTAGE
FAILURES

TRANSBOND PLUS 5 3.12%

0.008

RELIANCE SEP 2 1.25%

Bar Diagram showing bracket bond failures in Group A and Group B

4.5
4
3.5
3
2.5
Transbond Plus
2
Reliance S.E.P.
1.5
1
0.5
0
Group A Group B

49
Bar Diagram showing bracket bond failures in the anterior and posterior
segments of the arch:

3.5

2.5

2
Transbond Plus
1.5
Reliance S.E.P.
1

0.5

0
Anteriors Posteriors

Out of the seven bracket bond failures recorded, three bond failures

occurred in the anterior segment and four bond failures occurred in the

posterior segment.

Chi-square tests showed no statistically significant differences in bond

failure rate between brackets bonded in the anterior and posterior

segments of the arch.

50
 CONSORT DIAGRAM FOR THE STUDY

Total number of brackets

bonded (n = 320)

No. of brackets bonded in No. of brackets bonded in

Group A ( n = 160) Group B ( n = 160)

Bracket bond failures Bracket bond failures

in Transbond Plus SEP in Transbond Plus
(n = 4) SEP (n = 1)

Bracket bond failures in Bracket bond failures in

Reliance SEP ( n = 1) Reliance SEP (n = 1)

Total number of bracket bond failures = 7

Total number of bracket bond failures with Transbond Plus SEP = 5

Total number of bracket bond failures with Reliance SEP = 2

51
 Discussion

52
 DISCUSSION

The advent of bonding has brought about a radical change in the

concept of bonding orthodontic attachment. Efficient orthodontic

treatment with fixed appliances requires adequate bonding of brackets to

the enamel surfaces of the teeth.

Over the last 50 years, the bonding of various adhesives to enamel

and dentin has developed a niche in nearly all areas of dentistry, includ-

ing orthodontics. Adhesion is currently described as a combination of

mechanical, adsorption, diffusion, and electrostatic phenomena.

Mechanical theories propose that adhesion occurs primarily through

microscopic interlocks between the enamel and the adhesive40. The

clinical significance of using these microscopic interlocks for bonding

followed the introduction of the enamel acid-etch technique by

Buonocore11 in 1955. By demonstrating a 100-fold increase in retention

of small polymethylmethacrylate buttons to teeth that had been etched

with 85% phosphoric acid for 30 seconds, Buonocore opened the door to

modern adhesive dentistry techniques. Its use in orthodontics was

pioneered by Newman34 and latter refined by Miura et al30.

Bonding in orthodontics evolved into a system with a three step

process of preparing the tooth’s enamel surfaces with 37% phosphoric

acid etchant, followed by a priming agent, and then adhesive resin. One of

53
the potential disadvantages of etching with phosphoric acid is that the

acid causes demineralization of the most superficial enamel layer11. In an

attempt to control the depth of enamel etching and excessive enamel loss

many researchers have studied adhesion to enamel with different

modalities like maleic acid, polyacrylic acid, air abrasion as an alternative

to phosphoric acid. The use of maleic acid, poly acrylic acid has been

found to result in a reduction in bond strength60.

Phosphoric acid has remained the primary etchant since its

introduction by Bunocore. Studies indicated that a phosphoric acid

concentration of between 30% to 40% results in most retentive etching

pattern17, for most current clinical phosphoric acid application 37% acid

concentration is used.

Etching causes dissolution of interprismatic material in the enamel

producing an irregular enamel surface facilitating the retention of an

orthodontic attachment via its bonding agent. Since the depth of enamel

dissolution during the etching process is important, the potential use of

alternative enamel conditioners has been studied to improve the bonding

procedure by minimizing enamel loss and reducing chair time while still

maintaining sufficient bond strengths between brackets and enamel.

Although these conditioners were initially developed for use on dentin,

researchers determined that adhesive systems combining conditioning

54
and priming can be successfully used to bond orthodontic brackets to

enamel.

Recent advances in dental bonding chemistry allow the

combination of the etchant and primer into one product called a Self

Etching Primer composed of a methacrylated phosphoric acid esters. In

the 1990’s SEP was introduced as a means of reducing chair time during

bonding. Questions about resultant bond strength have been studied both

in vitro and in-vivo. Adequate clinical bond strengths in orthodontics

range from 5.9 to 7.9 MPa as reported by Reynolds and Von

Fraunhofer50, Aljubouri et al2 found that mean SBS of brackets bonded

with Self etching primer was lower than those bonded with a

conventional etch.

Revolutionary advances in adhesive chemistry are changing the

process of orthodontic bonding. Prompt L-Pop, a Self-Etching Primer,

was the first sixth-generation adhesive to be released to the dental

market67. The same chemistry is employed in the Transbond Plus Self-

Etching Primer, an identical product marketed specifically for

orthodontics, introduced by 3M Unitek (Monrovia, Calif) in the late

2000. Although fifth-generation adhesives allowed clinicians to bond in a

moist environment, they still required etching with phosphoric acid to

achieve the bond strength necessary for orthodontic applications. Bond

55
failures can occur if the etchant is left on too long, which yields weak

enamel rods, or if it is not rinsed properly, which reduces the bond

strength. The sixth-generation primers provide comparable bond strengths

without the time-consuming process of applying and rinsing the etchant. 67

It has been reported that most bond failures occur within the first 3

– 6 months following bracket placement ( Hegarty and Macfarlane 22 ;

Aljubouri et al3 ; O’Brien et al.36 ). Aljubouri3 and O’Brien36 observed

bracket failure rates of 50 and 82 per cent, respectively, during the first 6

months. Hegarty and Macfarlane22 noted failure rates of 54 per cent

during the first 3 months.

36
O’Brien discussed three possible reasons for this increased

failure rate during the first 6 months of treatment:

(1) any deficiencies in the bond strength of any individual

bracket/adhesive combination would become evident within this initial

period of treatment,

(2) the initial period of treatment is also a time of acclimatization and

experimentation for patients concerning the type of food that can be

tolerated by fixed orthodontic appliances, and

(3) the initial phase of treatment may involve a period of overbite

depression and, as a consequence, heavy occlusal forces may be applied

to many of the bonded attachments.

56
 The purpose of this study was to compare the bracket bond failure

rate with two commercially available Self Etching Primers during the

leveling and aligning stage of treatment.

Bond failure rates obtained by in-vitro studies might not mirror the

real world of clinical practice. Most studies are conducted in vitro and use

shear/peel or tensile forces to evaluate bond strength. Sunna and Rock 56

found that in-vitro bond strengths had no correlation with clinical bond

failure rates.

One explanation might be that brackets bonded to teeth

undergoing orthodontic treatment are subjected to many different forces

(eg, torque, shear, tensile) and might be subjected to more than 1 type

simultaneously. Conversely, in-vitro studies test only pure shear or pure

tensile forces independently; this might not accurately represent the

intraoral environment. Ultimately, the in-vivo bond failure rate will

determine the usefulness of a particular bonding system, and caution

should be used when inferences are made from in-vitro bonding studies.

To date, published reports on the in-vivo efficacy of SEPs for orthodontic

bonding are limited. 45

Keeping this aspect in mind, it was the aim of this in – vivo study

to compare the bracket bond failure rate and thereby the clinic al

efficiency of the Transbond Plus SEP and the Reliance SEP.

57
 Failure rates were compared between anterior and posterior teeth.

The overwhelming conclusion from other studies is that posterior teeth

suffer more bracket failure than incisors and canines. 36, 56

A number of

possible explanations for this are given – difficult clinical access and

isolation from moisture in the posterior regions, higher occlusal forces on

posterior teeth and more aprismatic enamel on premolars. The results of

this study were in contrast to these other studies in that there was a failure

rate of 0.9% for anterior and 1.25% for posterior teeth; however, this was

not statistically significant.

A study done by Manning et al28 comparing the bond failure rate

of brackets bonded with SEP and conventional acid etching also found no

significance in the bracket bond failure rates in the anterior and posterior

segments.

All patients who participated in the study underwent oral

prophylaxis and all teeth to be bonded were pumice polished to remove

any plaque and debris. Daniel J. Lill, Steven J. Lindauer et al27

conducted a study evaluating the importance of pumice prophylaxis for

bonding with self etching primer, and concluded that there was a

significant increase in the bond failure rate of brackets bonded with SEP

if pumice prophylaxis was omitted.

The light curing kit used in this study is the Ortholux™ XT Curing

Light (3M Unitek, Monrovia, CA). This is a conventional light curing

58
unit, which uses a halogen lamp to generate a white light which is then

filtered so that only blue light in the 400 to 500 nanometer range is

emitted from the tip. Each bracket bonded in this study was cured for a

total time of 25 seconds each, curing the labial, occlusal, gingival, mesial

and distal aspect of the bracket for 5 seconds each.

The two Self Etching Primers used in this study were:

Transbond Plus SEP

Reliance SEP

The twenty patients, who participated in this study, were

randomly allocated to two groups, Group A and Group B, using the

GraphPad Software, available online. (www.graphpad.com/quickcalcs). This

random number generator is seeded with the time of the day, so it works

differently each time it is used. Each patient is first assigned to a group

non randomly. Then the assignment of each subject is swapped with the

group assignment of a randomly chosen subject.

Group A consisted of ten patients bonded with Transbond Plus

SEP (3M Unitek) on the maxillary right and the mandibular left

quadrants; and the Reliance SEP on the maxillary left and mandibular

right quadrants.

59
 Group B consisted of the remaining ten patients bonded with the

Reliance SEP on the maxillary right and mandibular left quadrants and

the Transbond Plus SEP on the maxillary left and mandibular right

quadrants.

This totaled to 320 teeth being bonded; out of which 160 teeth

were bonded with the Transbond Plus SEP and the other 160 teeth with

the Reliance SEP.

The Transbond Plus SEP combines etchant and primer in a three-

well, single-patient use foil pack with an advanced delivery system. The

first compartment (black reservoir) contains methacrylated phosphoric

acid esters, initiators, and stabilizers. The middle compartment (white

reservoir) contains water, fluoride complex, and stabilizers. The third

compartment (purple reservoir) contains the removable applicator tip.

For activation, the thumb and index finger are used to squeeze the

black reservoir and empty the contents of the first compartment into the

middle compartment (white reservoir). To keep the liquid from flowing

back into the black reservoir, the package is carefully kept folded at the

interface of the black and white reservoir. Using controlled pressure, the

liquid is squeezed into the third compartment (purple reservoir). The

applicator tip is then churned and swirled inside the purple reservoir for 5

seconds, to completely mix the chemicals and thoroughly coat the

60
applicator tip. The applicator tip is then removed. It must be moist and

have a light yellow color.

The saturated tip of the applicator is then rubbed on the tooth

surface, in small circular motions, for 3 to 5 seconds per tooth. The

phosphate group of the methacrylated phosphoric acid ester dissolves the

calcium from the enamel and removes it from the hydroxylapatite. Rather

than being rinsed away, the calcium forms a complex with the phosphate

group and is incorporated into the network when the primer polymerizes.

Because the sixth-generation primers remain in their unit-dose packages,

there is less evaporation and thus a more stable viscosity and wetting

capability. The applicator tip is dipped again into the reservoir to saturate

it, before rubbing it onto the next tooth. When all the teeth in the

particular quadrant are primed, an oil and moisture-free air source is used

to deliver a gentle burst of air onto each tooth, to dry the primer into a

thin film. The gentle burst of air is directed away from the gingiva, so as

to avoid any gingival irritation that may occur with the primer fluid

seeping into the gingival sulcus.

Bonding of the brackets using TransbondTM XT adhesive followed

the priming procedure. After proper bracket positioning, and removal of

excessive adhesive using a scaler, the brackets were light cured using the

OrtholuxTM XT curing light.

61
 Asgari et al5 recently evaluated Transbond Plus Self etching

primer versus a traditional acid etch sequence in vivo and found that

those brackets bonded with Self etching primer had a significantly lower

incidence of debond. They incorporated a pumice prophylaxis for all

groups. Similarly, a recent in vivo study by Ireland et al24 tested

Transbond Plus Self etching primer versus conventional etch but

disregarded the pumice prophylaxis step for all groups. They found a

significantly greater number of bond failures occurring within the Self

etching primer group.

Self etching primer has been shown to produce a weaker bond

than a conventional etch methods in vitro, so pumice pretreatment might

be necessary to ensure a cleaner enamel surface for maximum efficacy of

Self etching primer clinically. According to the manufacturer’s

recommendations a pumice prophylaxis step should be incorporated

before beginning the bonding process with Self etching primer. This

pretreatment procedure removes organic material including the acquired

pellicle27.

Historically, it was assumed that the primary mechanism of

retention during bonding was the mechanical interlocking between the

enamel and the adhesive. As a result, it was thought that a deeper etching

pattern would provide a greater surface area for bonding and, thus,

62
greater bonding strengths 39. However, in a test of 3 SEPs on unground

enamel, no correlation was seen between etching aggressiveness and

tensile strength, as reported by Pashley and Tay44.

Other studies showed that SEPs that produce shallow, less-defined

etch patterns on ground enamel achieve similar SBS as those with a

deeper etching pattern. 47 SEPs have different pHs, penetration abilities,

and SBS values. This range of pH-penetration ability and how it

influences the SBS of orthodontic brackets has not been tested.

Anthony Pasquale 45 comparatively assess the bond failure rates of

orthodontic brackets bonded with 2 self-etching primer (SEP) bonding

systems; Transbond Plus SEP (3M Unitek) and Ideal 1 SEP (GAC

International) over an 18-month period. They concluded that the Ideal 1

SEP bonding system had 3 times as many bracket failures as the

Transbond Plus SEP bonding system; and that clinicians should consider

the many associated costs of bracket failures (chair time, material costs)

when choosing bonding systems.

The Reliance SEP (Reliance Orthodontic Products; Itasca, Il) is a

recently introduced Self Etching Primer in the market and is contained in

a hand-held dispenser. This two-way dispenser releases two liquids in a

3:1 ratio, into a light impervious mixing well. The first liquid contains

nitric acid, and the second liquid contains Bis (2-(methacryloyloxy)ethyl)

63
phosphate and Polyethlene glycol dimethacrylate. Once the liquids are

dispensed into the mixing well, they are mixed well using an applicator

brush and the remaining liquid is covered in the mixing well to protect it

from light. The manufacturers claim that the mixed solution of the self

etching primer can be usable for upto six hours if covered in the mixing

well. This minimizes wastage of the material.

Once thoroughly mixed, the applicator brush is rubbed onto the

enamel surface for 10 seconds in a circular motion. Once all the teeth in

the particular quadrant are primed, a gentle burst of air is delivered to

each tooth, away from the gingival, so as to dry the primer into a thin

film. This step is followed with bracket bonding and light curing

procedures, similar to the steps followed after application of the

Transbond Plus SEP. The Reliance SEP is intended for use only with

light cure adhesives.

Since the product is new to the orthodontic market, literature on the

Reliance SEP is minimal. A recent paper presented at the International

Association of Dental Research by L. Evans, K.R. Mc Grory, J.

English18, compared the shear bond strengths of three SEP's – Transbond

Plus SEP, Reliance SEP and Ideal-1 Self Etching Primer; to a

conventional bonding system, and also looked at how each responded

when contaminated with either saliva or water. The in-vitro study used

240 bovine incisor teeth and divided them into 4 groups of 60 each. In

64
five of the six groups that compared the primers, Reliance SEP had the

highest bond strengths. However, for two of the groups, the

measurements were not significantly different than those of the

conventional phosphoric acid etching system. In all six groups, GAC

Ideal 1 had the lowest bond strengths. They concluded that both

Transbond Plus Self-etching Primer and Reliance Self-etching Primer had

bond strengths similar to those of the control group treated with

phosphoric acid.

The results of this study showed a clinically significant, fewer

bracket bond failure rates with the Reliance Self Etching Primer when

compared with the Transbond Plus Self Etching Primer. Out of the total

320 brackets bonded, 7 brackets showed bond failure. The Transbond

Plus SEP had 5 bracket bond failures, while the Reliance SEP had 2

bracket bond failures.

65
Summary & Conclusion

66
 SUMMARY AND CONCLUSION

In this study we evaluated the clinical bracket bond failure rate of

two Self Etching Primers, the Transbond Plus S.E.P. and the newly

introduced Reliance S.E.P.

The results of the statistical tests showed that the Reliance S.E.P.

had fewer bracket bond failures clinically when compared to the

Transbond Plus S.E.P.

Based on the statistical results derived from this study, the following

conclusions were drawn:

1. The Reliance S.E.P. is a suitable alternative to the commonly used

Transbond Plus S.E.P. as it showed clinically fewer bracket bond failures

in this study.

2. Since the Reliance SEP is contained in cartridges and the unused

solution can be stored for upto six hours in light impervious mixing wells,

there is minimal wastage of the material.

3. There was no statistically significant differences found between

bracket bond failures between the anterior and posterior segments of the

arch.

The Self- etching primer that has been introduced to overcome the

laborious process of etching and priming will definitely reduce the chair
67
side time and the ill effects of acid etching. By reducing the number of

steps during bonding, the clinicians are able to save time as well as

reduce the potential for error and contamination during the bonding

procedure.

Since the Reliance SEP is a newly introduced Self Etching Primer,

and due to the lack of literature-based efficiency, further in-vivo studies

should be conducted to evaluate the same.

68
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