KTH Royal Institute of Technology

SD2414 Fiber Composites - Materials and Manufacturing

Project Assignement: Composite Dental Implant

Author: Alessandro Forestieri (fores@kth.se) Leif Davila Reinius (leifdr@kth.se)

Subtask 1: Product Specification

1.1 Product In this project the development of a composite dental implant has been considered: the studied object consists of a root device which supports the restorations and is usually made of titanium. The major benefits of making the dental implant in composite material could be the lower costs, a higher corrosion resistance, a longer product life and a lower mismatch of the mechanical properties between the bone and the implant (the properties of the composites can be modulated by changing the volume fraction of fiber and matrix). Moreover the dental industry is a potential nice market from many perspectives and is in continuously growing with lots of money spent in research: take part in such a market could be really successful also from an economical point of view.

1.2 Commercial implant In order to find the weight, performance and characteristics of the dental implants available today, the used data have been taken from the Nobel Biocare, a company operating in dental implantology and aesthetic dental solutions which owns the 22% of the dental implants market. Since different types of dental implants are used, the Brnemark System is used as benchmark. It is the original and the most versatile implant system in the Nobel Biocare and has an external hex connection. The model chosen (from which the specifications for the design will be kept) is the Brnemark System Mk IV TiUnite RP (fig 1.1).

Figure 1

The tab 1 shows the dimension for the design.

Type 3.3x13mm A 0.7 B 0.3 C 0.5 D 1.0 E 3.35 F 2.85
Table 1

G 12.23

H 12.5

I 3.15

J 2.65

K 1.8

L 3.5

M 2.4

The material characteristics of Nobel Biocare implants and standard commercial implants are reported respectively in figure 2 and 3.

Figure 2

Figure 3

1.3 Cost and production An approximate cost for a commercial single implant is around 200-300 Euro: the developed product should be cheaper, according to the aim of the project. An annual production, taking in account the competition and the different kind of implants existing, is estimated to be around 15000 pieces. 1.4 Further Requirements After that the dimensions and the design of the implant has been established there are other important characteristics to be checked. Among the most important there are the biological compatibility for surrounding vital tissues, the mechanical compatibility to smooth transfer the stress between the placed implant root and receiving hard tissue, the osseointegration, the morphological compatibility (possibility to easily modify the surface), the durability and the corrosion resistance: all these characteristics have to be checked in an experimental and detailed study and are not fully considered through the project, so only further studies could confirm the actual applicability of the developed object. What have been checked are the biocompatibility, together with the resistance to the surrounding vital tissues and the dimensional stability, in the choice of the material (see 2.1 choice of the material), suitable mechanical properties to allow the implant to resist to the main loads and the processing and economical aspects. The temperature of work of the implant will be about 37 since this is the oral temperature.

Subtask 2: Material evaluation

2.1 Choice of material The material reinforcements and the matrix system has been chosen following the materials requirements. These are, for the application chosen, the fatigue resistance, the biocompatibility (which include the absence of migrating additives and the fact that these additives and the material itself has to be accepted by the tissue without allergic, inflammatory or toxic reaction), the resistance to the surrounding vital tissue, the dimensional stability. Matrix reinforcement that fulfill these requirements are, among the others, PMMA and PEEK. In particular Carbon fiber reinforced polyetheretherketone (CF/PEEK) systems have been shown to have high stability, good tolerance by in vivo tissue, good resistance to hydrolysis and applicability for structural permanent implants [3]. Moreover fretting and sliding wear tests showed an improving wear resistance of the CF/PEEK composite with respect to titanium-alloys material: this could be a further advantage of the composite dental implant. So the chosen matrix and reinforcement are respectively PEEK and Carbon Fiber. Particularly it has been decided to use low modulus carbon fiber because they show less difference between the longitudinal modulus and the transversal one: since the fibers will be only disposed in the direction 1 (the most stressed) it is thought to be safer to have a good rigidity also in the direction 2. In table 2 and 3 the mechanical characteristics of the chosen components are listed [4]: Matrix PEEK (Kg/m3) 1260-1320 avg 1290 E (GPa) 3,2
Table 2

(MPa) 93

(%) 50

Reinforcement (Kg/m3) CF (LM) 1700-1830

avg 1765

El (GPa) Et (GPa) (MPa) 230 40 2340-7070

Table 3

(%) 0,8-2,2

2.2 Mechanical analysis The dental implant is thought to be made like a full cylinder containing the matrix and the fibers disposed parallel to the main axis: indeed this will be the most solicited direction. The cylindrical part is then surrounded by the thread composed by only matrix. For the calculations the cylinder is consider to have a radii that is a media of the values K and F in table 1 and an high equal to H. So

As regard the forces acting on the implant the worst situation that it can experience is probably the compression upon mastication. In the molar region the biting force has been registered to reach 800 N [5]. Instead the deflection of the tooth which can result from an horizontal force acting on the tooth has to not exceed the 0.15 mm (the mobility of the tooth is considered to be normal if it doesnt exceed this value [5]). Anyway the dental implant is almost all inside the bone so it will not determinate the deflection of the tooth: rather than this the tooth should have a Young modulus close to that of the bone to improve its compatibility. Currey (1964) and Bonfield and Li (1967), considering the bone as constituted by two phases, the organic phase (collagen) and the mineral phase (hydroxyapatite), used the ROM (Rule of Mixtures) to predict the bone modulus. This procedure is also known as Voigt model and gives the upper bone modulus, which has estimated to be [6]:

So the dental implant should have a modulus as close as possible to Eb and at the same time should resist to a compression force of 800 N.

2.2.1 Compression

Figure 4

In the chosen approximation only the central, cylindrical part, with the fibers in direction 1, is considered (the thread, made of matrix, is not thought to act and bring the load). The force acting in compression, in the direction 1, is decided to be 800N as stated before: this force deforms the cylinder of a value that has to be lower than the deformability of the fiber: (%)= 0,8-2,2 The lower value has been considered to be in a safer condition. Using the ROM (Rule of Mixtures) parallel model, it results that the deformation is the same for matrix and fibers:

So

Then the compression stress is 47,1 MPa. Then the minimum modulus should be:

2.2.2 Bones modulus As stated before the dental implant should have a modulus similar to that of the bone to improve its compatibility: now that it has been shown that the bone modulus (Eb=57,6 GPa) it is higher than the one necessary to resist to the compression load, it is reasonable to assign at the composite implant a modulus equal to Eb. In this way, using the ROM, it is possible to estimate the volume fraction of matrix and fibres in direction 1.

Where Vf and Vm are the volume fraction of fibers and the volume fraction of matrix, respectively .

So, to have the decided modulus with the properties of the selected materials, the volume fraction of fibers and matrix are, respectively:

From the volume fraction it is possible to compute the weight fraction of the fibers using the following formula:

This gives the weight fraction of matrix material Wm:

Using the serial model (which gives a lower bound of the elastic modulus, often not so near to the experimental results) it is possible to determine the Youngs modulus of the implant in the transversal direction: ( ) ( )

It is also possible to predict the upper value of the ultimate strength in direction 1 even if the assumptions to be made are strong and the resulting value is always higher than the real (experimental) one:

From the tab 3 it has been taken the lowest value of the ultimate strength for the fibers, to be in a safer condition and also because the model adopted already brings to an overestimation of the strength. The volume of the implant is:

Using the density in tab 2 and 3 (more specifically the media of the density in the tab) and the volume fractions it is possible to make an estimation of the weight:

In conclusion the property of the dental implant, neglecting the thread, are:

E1 (GPa) 57,6

E2(GPa) 4,1

1(MPa) 632,3

Vf 0,24

Wf 0,302
Table 4

Vm 0,76

Wm 0,698

V (mm3) 212,3

W (g) 0,298

Subtask 3: Processing

3.1 Requirements The processing method should be suitable for the fabrication of good quality continuous carbon fiber in a PEEK matrix (so the use of a thermoplastic technique is required). The PEEK matrix has a Tg of 145 C and a Tm of 345 C [4]. The volume fraction of fiber is 0,24 so it is not required a method to produce high volume fraction composite. Moreover better than a cost effective method, it is required a process able to form pieces with good mechanical properties, high quality and really precise geometry: indeed this are the requirements for a dental implant.

General features Dimension V (mm3) 212,3

Table 5

Vf 0,24

E1 (GPa) 57,6

Requirements Cost-effective Not fundamental Geometry and finishing Highly precise

Table 6

Mechanical properties good

Fiber arrangement Longitudinally orientated

Considering the shape, the size, the design of the object, the fiber arrangement and the other requirements, the way to manufacture a screw could be the use of Thermoplastic Pultrusion to create a rod followed by the Composite Transfer Squeeze Forming (CTSF) [7] to make the thread.

3.2 Pultrusion Pultrusion is the common way to produce continuous composite component and it is also cost-effective: it is an automatic, continuous and high speed process. Thermoplastic pultrusion it is not so common and competitive but it is still possible and it is probably the best way to obtain a rod with longitudinally orientated fibers: indeed Compression Molding is mainly used for random fibers (even if continuous and oriented arrangement are possible) and Liquid Molding produce component with surface fibers parallel to the surface but with perpendicular or random arrangement in the interior. The raw material should be in the form of melt-impregnated prepregs to result in the best component properties and highest pulling speed (when the impregnation process is part of the pultrusion the impregnation results less good). The prepreg is introduced into the die passing through a preheat. Usually two separate dies must be used, the last of them is cooled and with constant cross-section.

Figure 5 from [8]

The length of an individual die is in the order of 100 mm. So the two dies will keep a space of approximately 200 mm. The approximately value for the temperature is 350 in the taper section and 150 in the heated die [8]. From the heated die to the cooled one the matrix solidifies: the time necessary for this process depends on the die lengths, die temperature and the pulling speed. The latter influences the mechanical properties. The time for the pultrusion process can be assumed to be around 2 minutes per piece.

3.3 Composite Transfer Squeeze Forming Once that the rod is formed via pultrusion technique it is possible to confer the final shape to the screw (making the thread) by a single-step net-shape processing using the Composite Transfer Squeeze Forming (CTSF) [7]. This process is cost effective and, also more important for the considered application, the fibers will be hardly damaged and they can be long as much as the fastener. Moreover the screws formed in this way show very good mechanical properties [7]. The method consists in the heating of the pultruted rod above the resins melting point in the rodchamber. The rod is then squeezed into a pre heated moulding cavity and assumes the screw design. The processing parameters are strictly dependent to the resin and the geometry used. Anyway the production time for a CF/PEEK prototype is about 8 minutes with a used processing temperature of 400 C [7].

Figure 6 from [7]: The rod (1) the rod-chamber (2) stamp to squeeze the rod (3) the moulding cavity (4) fastener (5)

3.3 Processing Time Without considering the transport from the pultrusion plant to the CTSF one (it can be negligible if the process is continuous and automated) the total time of the process will be approximately: 2 min + 8 min = 10 minutes per piece.

3.4 Mould: material and fabrication The mold is probably the most critical aspect for the manufacture of the object: to create the composite dental implant it is necessary to have a precise die in the pultrusion process and a high quality mold in the CTSF. The most important requirement for the mold material is the coefficient of thermal expansion (CTE) that has to be as close as possible to the one of the component.

Considering the representative CTEs for different common materials [4] it is reasonable to choose an aluminum ( mold that also allows a mold fabrication through direct machining: a computer controlled grinding facility is used to machine the shape of the mold from a solid metal block following a CAD model. The so created molds are expensive but durable and able to tolerate high temperature: this technique is then suitable for the fabrication of both the die and the mold of the CTSF. 3.4 Final Consideration The process is not time consuming since pultrusion has a continuous and automated nature and also the CTSF could be relatively fast if automated. Moreover we are dealing with thermoplastics which involve shorter demolding times. The major disadvantage could be the cost of the process, mainly due to the high processing temperatures needed, the high viscosity of the matrix and the use of melt-impregnated prepregs.

Subtask 4: Product economy and product feasibility

4.1 Raw material cost The first thing to consider estimating the final product cost is the raw material cost. Considering the weight of the reinforcement and of the matrix per piece and an annual production rate of 15000 pieces (according to 1.3 Cost and production) it is possible to estimate the raw material needed per year of production. Then, using the prices given in [9], an estimation of the raw material cost per year is made.

Material Weight per piece (g) CF(LM) PEEK 0,089 0,208

Weight needed per year (kg) 1,335 3,12

Table 7

Price (SEEK/Kg) 400 700

Price per year (SEEK) 534 2184

Since the manifacturing method requires prepregs it is needed to moltiplay the raw material cost for a factor of 2-3. For this case a factor of 3 has been used. So the prepregs cost per year is:

4.2 Manpower requirements/cost The manpower required is not high since the manufacturing process should be automated. Furthermore, for the few manpower required, the health concerns are not a problem because thermoplastics allow a good work environment. It is possible to estimate the manpower cost around 192 000 Euro per year (8 workers with an average salary of 2000 euro per month).

4.3 Equipment cost The manufacturing process is not time consuming (the estimated time for the whole process is 10 minutes per piece) and is automated (few manpower required). The main part of the cost will probably consists in the equipment cost and in the high processing temperatures needed. Pultrusion equipment cost varies depending on the part envelope size, the pulling capacity and if the process is continuous or not [10]. The figure 7 shows the approximate cost as a function of the pulling capacity.

Figure 7 from [10]

Considering an average pulling capacity it is possible to estimate the equipment cost to be around 200 000 $. The Composite Transfer Squeeze Molding (CTSF) is a relatively new technique and no data concerning the equipment cost are available. However a suitable price for that equipment (at least in the order of magnitude), considering that the pultrusion has an intermediate cost with respect to the high cost of the injection molding, could be around 400 000$. So the total equipment cost will be about 600 00 $ 460 000 Euro. It is also possible to roughly estimate the energy consumption for the process to be around 20 KW/h (the energy consumption for a standard pultrusion

process is indeed 20 KW/h according to [11] and the same value has been taken for the CTSF for the absence of available data). So the energy consumption per year will be:

Using the average cost of electricity (the cost in Sweden has been taken as reference), taken from [12], it results an energy cost per year equal to:

4.3.1 CTSF Aluminum mold cost A cad model is needed to design the mold. It is then possible to use a CNCmachine which can carve out the mold (in a precise way) in approximately 10 hours. The cost for this is around 70 Euro/hour. So the cost to make the mold is:

The price for aluminum is approximately 1,1 Euro/kg. Guessing that the material needed is approximated 1 dm3 of aluminum (2,7kg aluminum) the material price to do the mold will be:

The mold must hold for manufacturing 15 000 screws and a Nikasil treatment against abrasion on the surface of the mold is needed: this costs about 200 Euro. Finally the estimated price to manufacture the mold will be around 800 Euro.

4.4 Product life The product is thought to be used once and to have a long life. Indeed, once it has been implanted, it has to last as much as possible: the CF/PEEK dental implant could involve a longer life with respect to the conventional titanium screws. Indeed, as stated in [13], a CF/PEEK screw shows excellent fatigue resistance, overalls the corrosion problems faced with metal, results stable in vivo conditions and is characterized by an angle stable screw positioning. In general the dental implants have a life span of approximately 15 years even if they could last for life. So, seen the better properties which characterized a composite implant in terms of durability, with respect to a conventional one, the product life is estimated to be around 20-30 years. 4.5 Conclusion As stated at the beginning (see 1.3) the average cost of titanium implant is 200300 Euro. The aim was to design a composite cheaper implant. Moreover this new type of implant will offer as major advantages an improved span life, a better corrosion resistance, fatigue resistance and mechanical properties closer to those of the bone. To see if even the requirement of a lower price has been satisfied, a cost analyses is needed. The tab 8 summarize the rough economics aspects. Raw material cost per year Annual production Estimated time for annual production Energy cost Manpower cost Equipment cost Mold cost Profit for 15 000 sold pieces
Table 8

918 Euro 15 000 pieces 150000 min 2500 h 10 000 Euro 192 000 Euro 460 000 Euro 800 Euro 3000000 Euro

According to the estimations done the product cost will be:

On the market the cost is usually 2-3 times higher than the product cost: since we are dealing with the biomedical industry the price could be easily 3 times the product cost. So the price of the composite dental implant results 132 Euro. Not all the costs, the economical and mechanical (for example the design of the roughness is very important for such application) aspects have been considered but anyway the product seems to be competitive and could represent a great alternative to the standard titanium implant.

Sources: 1. http://www.nobelbiocare.com 2. http://www.dental-tribune.com 3. Joao F.Mano, Rui A.Sousa, Luciano F.Boesel, Nuno M.Neves, Rui L.Reis, (2004), Bioinert, biodegradable and injectable polymeric matrix composites for hard tissue replacement: state of the art and recent developments, Composites Science and Technology 64 789817 4. B.T. strm (1997), Manifacturing of polymer composites 5. Dr. Angelo Caputo and Dr. Robert Wylie, Force Generation and Reaction Within the Periodontium 6. M. Elices (2000), Structural Biological Materials Volume, Design and Structure-Property Relationships 7. Tognini R., Loher U., Peter Th., Raschle R., Mayer J., Wintermantel E., Fatigue Properties of CF/PEEK Cortical Bone Screws Produced by Composite Transfer Squeeze Forming (CTSF) 8. Nicholas P. Cheremisinoff (1998), Advanced Polymer Processing Operations 9. Gutowski, TG, Advanced Composites Manufacturing, Wiley and Son, New York, USA, 1997 10. Anjali Goel (2000), Economics of Composite Material Manufacturing equipment 11.Lieping Ye, Peng Feng, Qingrui Yue, (CICE 2010) Advances in FRP Composites in Civil Engineering, Beijing, China 12.http://www.energy.eu/

13. S. Ramakrishna, J. Mayer, E. Wintermantel, Kam W. Leong (2000), Biomedical applications of polymer-composite materials: a review