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dental materials

Dental Materials 18 (2002) 281286 www.elsevier.com/locate/dental

New organosilicon maxillofacial prosthetic materials


J.H. Lai a,*, L.L. Wang a, C.C. Ko b, R.L. DeLong b, J.S. Hodges c
LAI Laboratories, Inc., 12101 16th Avenue South, Burnsville, MN 55337, USA Department of Oral Sciences, School of Dentistry, University of Minnesota, Minneapolis, MN, USA c Biostatistics Core, Oral Health Clinical Research Center, School of Dentistry, University of Minnesota, Minneapolis, MN, USA
b a

Received 27 July 2000; received in revised form 15 January 2001; accepted 20 February 2001

Abstract Objectives: The silicone elastomer A-2186 is a widely used maxillofacial prosthetic material. It is a pourable two-component silicone rubber cured by a platinum catalyst. Used as a prosthetic material, A-2186 has short working time and because of its hydrophobic nature, poor adhesion to non-silicone based adhesives. The purpose of this study is to evaluate the physical properties of new prosthetic materials based on methacryloxypropyl-terminated polydimethylsiloxane (MPDS-MF), and to compare the properties with those of A-2186. Methods: Hardness, tensile strength, ultimate elongation, tear strength and adhesive bonding strength of MPDS-MF and A-2186 with and without additives were determined and compared. The bonding strengths of the extrinsic colorant carrier with the prosthetic materials were also determined. Statistical analyses were done using a two-way analysis of variance (ANOVA). For signicant effects, post-hoc tests were done using the Bonferroni correction. Results: The hardness of MPDS-MF is similar to A-2186. However, tensile strength, tear strength, ultimate elongation, and adhesive bonding strength of MPDS-MF are higher than those of A-2186. Signicance: MPDS-MF is cured by free radical thermal polymerization and crosslinking. The working time of MPDS-MF, unlike A2186, is long. The presence of methacrylate groups in MPDS-MF enhances its adhesion to non-silicone based adhesive. Based on the present study, it appears that MPDS-MF is suitable for use in fabricating of clinical prostheses. q 2002 Academy of Dental Materials. Published by Elsevier Science Ltd. All rights reserved.
Keywords: Maxillofacial prosthetic materials; Physical properties; Pigment; Adhesives

1. Introduction The most widely used materials for maxillofacial prostheses are the silicone elastomers [13]. The three most common silicones used for maxillofacial prostheses are Dow Corning MDX4-4210, Dow Corning Medical Adhesive Type A, and Factor II, Inc.'s A-2186 [4]. The major components in A-2186 and MDX4-4210 are similar. Each is a pourable two-component silicone rubber, and both materials cure by the same mechanism. The elastomer component consists of a dimethylsiloxane polymer (polydimethylsiloxane), reinforcing silica and a platinum catalyst. The curing agent component consists of a dimethylsiloxane polymer, an inhibitor and a siloxane crosslinker. The crosslinking reactions in both elastomers are catalyzed by a platinum complex that involve the addition of silyl hydride groups (ZSiH) in the silicone (polydimethylsiloxane) to the vinyl groups (CH2yCHZ) in the
* Corresponding author. Tel.: 11-602-882-0717; fax: 11-612-882-8736. E-mail address: jlai@aol.com (J.H. Lai).

other silicones. Although the materials have improved tear strength [5,6], both A-2186 and MDX4-4210 have low adhesion to non-silicone-based adhesives due to their hydrophobic nature. Because the curing reactions start immediately after the mixing of the two components, the working time of the materials is short. Medical Adhesive Type A is a hydroxyl-terminated polydimethylsiloxane, pre-mixed with the crosslinker methyl triacetoxy silane. Upon application and exposure to moistures, the silane molecules are hydrolyzed by the water, which then undergo crosslinking reactions with the hydroxyl groups of the polysiloxane. The crosslinking reactions produce acetic acid as the by-product. Because Medical Adhesive Type A requires moisture to cure, the cure time is too long for curing the material inside a mold. Therefore, Medical Adhesive Type A is normally limited to use as a carrier for the extrinsic colorants applied to the surface of the prosthesis [7]. Methacryloxypropyl-terminated polydimethylsiloxane (MPDS) is a silicone elastomer with a unique chemical structure. The crosslinkable polysiloxane provides the

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silicone elastomer characteristics. The dimethacrylate groups located on the chain ends readily undergo freeradical thermal polymerization and crosslinking. Incorporation of methacrylate groups in the silicone reduces the hydrophobicity of the silicone that enhances the adhesive bond strength to non-silicone-based adhesives. Because MPDS cures thermally, its working time for prosthesis fabrication is long. The physical properties of the new organosilicon maxillofacial prosthetic materials based on the methacryloxypropylterminated polydimethylsiloxane (MPDS-MF) are reported in this paper. In a subsequent paper, the clinical performance of maxillofacial prostheses made from MPDS-MF will be reported.

2. Materials and methods 2.1. Materials Four batches of polymer MPDS were used in this study. Batches DP-1 (3) and DP-1 (4) were used in the preliminary investigation. Batches DP-1 (5) and DP-1 (6) were used for optimization of the material formulations and to produce the test samples described in this paper. The batch DP-1 (5) was also used for making clinical prostheses. A Water high performance liquid chromatograph (HPLC) equipped with a refractive index detector was used in the analysis of polymer molecular weights with tetrahydrofuran as the solvent. The HPLC was calibrated using polystyrene standards with molecular weights ranging from 760 to 198,000 Daltons. The molecular weights, Mn, Mw and polydispersity of DP1 (5) and DP-1 (6) determined by the gel permeation chromatography are shown in the Table 1. In general, MPDS based maxillofacial materials MPDSMF were prepared by dispersing the thermal initiator in the polysiloxane MPDS rst, followed by thoroughly mixing the mixture with the llers and the additives. The MPDSMF material was then introduced to the mold and thermally cured. All stainless steel molds were cured in a convection oven. Stone molds were cured either in a convection oven or in a temperature-controlled water bath. Physical and mechanical properties of MPDS-MF are dependent on the degree of crosslinking and the type and the concentration of llers in the elastomer network. The degree of crosslinking depends on the nature and the concentration of the thermal initiator, the llers, and the additives, as well as cure temperature and cure time. For clinical applications, a short cure time would be desirable. However,
Table 1 Molecular weights of MPDS polymers Batch no. DP-1 (5) DP-1 (6) Mw 37,490 34,342 Mn 26,026 26,363 Polydispersity 1.440 1.302

because cure time and cure temperature interact, and both affect the physical properties of the materials, an experimental design response surface methodology, was used to optimize the material formulations and processing conditions. A full central composite design was used with thermal initiator concentration, cure temperature, and cure time as the three variables. Hardness, tensile strength, ultimate elongation, and tear strength were the four responses. Numerical optimization was performed using the DesignExpert software (Stat-Ease, Inc., Minneapolis, MN), and the optimum formulation and process conditions identied. MF-606 represents the optimum formulation designed for prosthetic application. A-2186 (Factor II, Inc., Lakeside, AZ, USA; Lot No. 377505) was supplied as a two-part material system, part A being the silicone elastomer base and part B the catalyst. Mixing of the two parts and application of A-2186 were done according to the Product Information, Technical Prole of A-2186 provided by Factor II, Inc. Part A and part B were mixed in a 10:1 ratio by weight. The mixture was packed into the molds immediately after mixing and then cured. Special care was exercised to minimize air entrapment. Several cure schedules are listed in the product information sheet, including 658C for 4 h and 1008C for 1 h. Two cure schedules were used to ensure a full cure: 678C for 8 h, or 1008C for 2 h. The mechanical properties of the (cured) MPDS-MF materials and A-2186 were determined for both materials with and without additives. Pigmented MPDS-MF and A2186 contained the following additives: 0.5% buff pigment (silicone paste, I-100 BU, diluted with silicone uid-200, 10:1, Factor II, Inc.), 0.8% Kaolin (Kaolin Powder Georgia, G-1001, Factor II, Inc.) and 0.05% ocking ber (Rayon ber, H-108-T Tan, Factor II, Inc.). For pigmented A2186, the additives were added to the part A silicone elastomer base and thoroughly mixed. This mixture was then mixed with the catalyst and cured. The mechanical properties determined include hardness, tensile strength, ultimate elongation, tear resistance, and adhesive bonding strength. 2.2. Hardness measurement Hardness of the material was determined using a Shore A Durometer according to ASTM Designation: D2240-86 [8]. A 3-piece stainless steel mold was constructed for making and curing the standardized cylindrical test specimens. The dimensions of the specimens were 1.5 in (diameter) 0.25 in (thickness). After it had cured, each test specimen was conditioned for 24 h at 238C and 50% RH. Five measurements of hardness were made at different positions on the specimen. Each measurement was made at least 6 mm from the edge and at least 6 mm from adjacent locations. The reported hardness is the mean value of the ve measurements. For each formulation, at least three specimens were measured.

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2.3. Tensile and tear strength measurements The tensile strength and ultimate elongation of the materials were determined using a MTS QTEST 1 Computerized Tester equipped with a High Elongation Extensometer (MTS System Corporation, Eden Prairie, MN, USA). The determinations were done according to ASTM designation: D412-92 [9]. Dumbbell shaped test specimens were made by heat curing the material in a 3-piece stainless steel mold or a 2-piece stone mold. Special care was exercised to prevent the trapping of air bubbles in the specimens. The thickness of the specimen was 2.5 mm, and the neck dimension was 30 20 mm. Test specimens were conditioned at 238C and 50% RH for 24 h prior to testing. The specimen was clamped between two grips that were pulled apart at 20 in/min. The tensile strength was calculated by QTEST 1's software Test Works from the force at break. The ultimate elongation was 100 (L 2 L0)/L0, where L0 is the original distance between bench marks and L is the distance at break between bench marks as measured by the extensometer. The ultimate elongation was also calculated using the software Test Works. Tear strength of the material was evaluated according to ASTM designation: D624-91 [10]. Test specimens were molded by heat curing in either a 2-piece stainless steel mold or stone mold, and were conditioned at 238C and 50% RH for 24 h prior to testing. Test specimens were of the standardized trouser shaped strips having dimensions of 75 25 1 mm with a 50 mm long cut. The grip separation rate was 10 in/min. The maximum force F in tearing the specimens recorded, and the tear strength Ts was calculated by using the formula Ts F/d, where d is the thickness of the test specimen. 2.4. Peel strength measurement The bonding strength of adhesives to the maxillofacial elastomers was characterized by the peel test [11,12]. Four adhesives were testedDow Corning 355 Medical Adhesive (also called Secure Medical Adhesive, Lot No. Was not provided by the vender), Hydrobond (Daro Products, Inc. Butler, WI, USA, Lot No. 012397), Hollister Medical Silicone Adhesive (Hollister, Inc., 2000 Hollister Drive, Libertyville, IL, USA, Lot No. 4134AD) and Dow
Table 2 Mechanical properties of MF-606 Cure method No pigment (MF-606-1) S S mold oven cure Stone mold oven cure Stone mold water bath cure Pigmented (MF-606-2) S S mold oven cure Stone mold oven cure Stone mold water bath cure Hardness 34.0 (0.6) 30.7 (0.9) 28.7 (2.1) 31.1 (0.6) 31.5 (0.6) 27.8 (1.1) Elongation (%) 358 (27) 404 (23) 471 (41.5) 358 (12) 383 (14) 455 (18)

Corning Siliastic Medical Adhesive Silicone Type A (Lot No. HH074982). The adhesives were all obtained from Factor II, Inc., Lakeside, AZ, USA. The specimen dimensions were 75 25 3 mm with a 25 25 mm area bonded by the adhesive. The specimen was placed in the QTEST 1 tester with the unattached prosthetic material tab bent back to a peeling angle of 1808. The specimen was then subject to a peeling force by separation of 12 in/min. until failure occurred. The force-per-unit-width of bond necessary to cause failure was determined, and the failure cause examined. Because the lm was relatively thick (3 mm), there was no signicant stretching of the lm during the peel test. For each peel test specimen, three thin layers of adhesive were applied evenly and successively to the bonding area of each of the two specimens to be bonded. Between each layer of application, 5 min of dry time was allowed. The two adhesive specimens were pressed together for ve minutes after application of the third layer of the adhesive. A 5 lb stainless steel weight was then placed on the top of the two bonding specimens for 2 h. The bonded test specimen was stored in a condition chamber at 23 ^ 18C and 50% RH for 24 h prior to the peel test. Because Medical Adhesive Type A requires moisture to cure fully, the test specimen containing Medical Adhesive Type A was conditioned in the partly opened condition chamber for 72 h or more. All statistical analyses were done using a two-way analysis of variance (ANOVA). For MF-606 (Table 2), the two factors in the ANOVA were pigmentation (present vs absent) and cure method (stainless steel mold cured in a convection oven, stone mold cured in a convection oven, and stone mold cured in water). The two factors comparing properties of MF-606 and A-2186 (Tables 3 and 4) were material (MF-606 vs A-2186) and pigmentation (present vs absent). For signicant effects, post-hoc tests were done using the Bonferroni correction. 3. Results The mechanical properties, hardness, ultimate elongation, tensile strength and tear strength, of MF-606 with and without additives are shown in Table 2. In naming MF-606-1 and MF-606-2, 606 designates the optimum formulation, 1 means not pigmented and 2 means pigmented. The data for

Tensile strength (MPa) 4.61 (0.34) 4.84 (0.16) 4.76 (0.42) 3.91 (0.16) 4.48 (0.12) 4.31 (0.18)

Tear Strength (N/cm) 162.80 (27.13) 181.03 (62.27) 184.15 (41.81) 160.57 (33.36) 187.26 (5.34) 202.82 (20.46)

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Table 3 Mechanical properties of MF-606 and A-2186 (all specimens were fabricated in stone molds and cured in a convection oven) Hardness No pigment MF-606-1 A-2186 Pigmented MF-606-2 A-2186 30.7 (0.9) 31.5 (1.1) 31.5 (0.6) 31.2 (1.0) Elongation (%) 404 (23) 307 (37) 383 (14) 293 (32) Tensile strength (MPa) 4.84 (0.16) 3.49 (0.63) 4.48 (0.12) 3.30 (0.35) Tear strength (N/cm) 181.03 (62.27) 102.70 (15.40) 187.26 (3.54) 86.50 (11.40)

MF-606 test specimens fabricated using stainless steel molds represent the average of seven specimens, while each data for those fabricated using stone molds is the average of four specimens. Effects of pigments on mechanical properties of MF-606 are shown in Table 2. Pigment did not have a signicant effect on elongation or tear strength (P . 0.17); however, it did affect the tensile strength and hardness. Tensile strength was greater in non-pigmented samples than in pigmented samples (P , 0.001). Non-pigmented samples were harder than pigmented when prepared in the stainless steel mold, but not in the stone mold. The pigment-by-cure interaction was signicant, P 0.001; comparing pigmented and nonpigmented, the P-values were P , 0.001, P , 0.3 and P , 0.24 for curing in stainless steel mold with oven, stone mold with oven, and stone mold with water bath, respectively. Mechanical properties of MF-606 are dependent on the nature of the molds and curing methods used in fabricating the test specimens. The three cured methods, stainless steel mold cured in a convection oven (SSO), stone mold cured in a convection oven (SMO), and stone mold cured in a water bath (SMW), did not cause signicant difference in the tear strength (P 0.12). Curing in a stainless steel mold produced samples that were harder than samples cured in stone molds (P 0.002 (SMO) and P , 0.001 (SMW), had lower percent elongation (P 0.002 (SMO) and P , 0.001 (SMW)), and lower tensile strength (P 0.002 (SMO) and P 0.022 (SMW)). The two stone mold cured methods did not differ in tensile strength (P 0.36); the oven-cured samples were harder, P , 0.001, and had lower elongation, P , 0.001, than the water cured samples.
Table 4 Adhesive bond strength of MF-606 and A-2186 Adhesive bond strength (N/cm) Medical Type A No pigment MF-606-1 A-2186 Pigmented MF-606-2 A-2186 17.12 (1.38) 11.97 (0.59) 17.72 (3.59) 11.80 (1.00)

Mechanical properties of MF-606 are compared with those of A-2186 in Table 3. The data shown in Table 3 were obtained from test specimens fabricated using stone molds and cured in a convection oven in air. The two materials did not differ for hardness, P 0.53. Ultimate elongation, tensile strength and tear strength were higher for MF-606 than A-2186, P , 0.001 for all three tests. Pigmentation did not degrade any of the mechanical properties. Table 4 shows adhesive bonding strength of MF-606 and A-2186 for four commonly used adhesives. Medical Type A Adhesive, Secure Medical Adhesive, and Hollister are silicone-based adhesives. Both MF-606 and A-2186 have adequate bonding strength to the silicone-based adhesives; however, MF-606 has signicantly higher bonding strength than A-2186 except for Hollister (P 0.007 for Hollister, P , 0.002 for the other two adhesives). The MF-606 bonding strength to Hydrobond which is a-non-silicone based adhesive in water emulsion is twice as high as A-2186, P , 0.001. As noted, Medical Type A Adhesive is used as the carrier for extrinsic colorants. Because the extrinsic colorant is applied on the surface of the prosthetic materials, the carrier should have high bonding strength to the prosthetic materials. In Table 5, it is seen that the pigmented Medical Type A Adhesive bonds strongly to the pigmented MF-606-2 for a variety of colorants (pigments). 4. Discussion Clinical prostheses are commonly fabricated by using

Secure Medical 3.90 (0.24) 3.33 (0.22) 4.32 (0.33) 3.39 (0.59)

Hydrobond 1.29 (0.31) 0.24 (0.08) 0.96 (0.12) 0.45 (0.25)

Hollister 4.36 (0.35) 3.52 (0.35) 3.88 (0.17) 3.46 (0.82)

J.H. Lai et al. / Dental Materials 18 (2002) 281286 Table 5 Adhesive bond strength of pigmented MF materials to pigmented Medical Type A adhesive MF material a MF-606-2 MF-606-2 MF-606-2 MF-606-2 MF-606-2 MF-606-2 MF-606-2
a b

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Pigment added to the Medical Type A adhesive b Monastral red Cosmetic yellow Raw sienna Suntan Red cosmetic Burnt sienna Red yellow

Peel strength (N/cm) 26.66 (4.31) 25.93 (11.55) 33.11 (1.30) 19.45 (6.46) 22.17 (4.38) 20.62 (6.88) 20.31 (5.39)

No. test specimen 3 3 2 4 2 4 2

Each MF material contained 0.5% buff, 0.8% Kaolin and 0.05% ocking ber. Medical Type A adhesive was rst dissolved in xylene, which contained 0.1% of pigment.

dental stone molds due to relative ease in making stone molds. However, stone molds are easy to break, difcult to clean, and cannot be used repeatedly. It was not practical to use stone molds for optimization of material formulations where many stone molds are needed. Instead, various stainless steel molds were used in fabricating test specimens for the optimization. The mechanical properties of MF materials cured in a convection oven using stainless steel molds were compared to those of the MF materials cured in stone molds (Table 2). Except for tear strength, there is a signicant difference in the mechanical properties for both non-pigmented material MF-606-1 and pigmented material MF-606-2. The nonpigmented materials cured in a stainless steel mold are harder than those cured in a stone mold. However, the hardness of pigmented materials did not depend on the mold or curing method. The samples cured in stone molds have higher ultimate elongation and tensile strength for both non-pigmented and pigmented MF-606. Because these properties are important for clinical prostheses, the dental stone is the better mold material for fabricating clinical prostheses. It is interesting to note that hardness and ultimate elongation of the specimens fabricated in stone molds and cured in a convection oven in air are slightly different from those cured in a water bath. The water bath cured specimens are softer and more stretchable. The reason for the difference is not known. Although the stone mold is not totally air tight, the surface of the stone mold that is in contact with MF elastomer is coated with the tin foil substitute COE-SEP (GC Lab Technologies, Inc., Lockport, IL, USA). The surfaces of the material appear to be smooth and fully cured, and showed no evidence of oxygen inhibition. Because the difference in the hardness and elongation is slight, it is concluded that for clinical applications using MPDS-MF, the dental stone mold can be cured either in a convection oven or in a water bath. Realistic coloration of external facial prostheses is important for patient satisfaction and acceptability. Coloration can be achieved by intrinsic and extrinsic coloration. Intrinsic coloration is the incorporation of suitable pigments into the

polymer network before cure. For this method to be successful, the pigments must be dispersible in the polymer and must not have signicant adverse effects on the physical properties of the base material. The effects of additives on the mechanical properties of MF-606 are shown in Tables 2 and 3. As already noted, the pigments affected the materials cured in the stainless steel molds, but not those cured in the stone molds. The effects of pigmentation on the adhesive bonding strength to the four adhesives, Medical Type A, Secure Medical, Hydrobond and Hollister, are shown in Table 4. The effect of pigmentation on the adhesive bond strength was not signicant. In extrinsic coloring, an adhesive such as Medical Adhesive Type A is diluted with a solvent and then mixed with a pigment. The colored adhesive is applied topically to the external surface of the prosthetic device. For this technique to be successful, the extrinsic colorants must adhere well to the prostheses. The bond strength of extrinsic colorants, i.e. pigmented Medical Type A adhesive, to the intrinsically pigmented maxillofacial material is shown in Table 5 for seven different colorants. The adhesive bond strengths are all seen to be high, thus the extrinsic coloration method described is well suited for MF-606-2. In this work, A-2186 was selected as the control. Physical properties of A-2186 have been determined and published [13]. The mechanical properties and the adhesive bond strength of the new MF-606 materials are compared with those of A-2186 in Tables 3 and 4, respectively. The adhesive bond strength of the new materials MF-606 and A-2186 are compared in Table 4. The hardness of both materials are similar, however, the tensile strength, tear strength and adhesive bonding strength of MF-606 are signicantly higher than those of A-2186. The bonding strength of MF606 to Hydrobond was twice that of A-2186. Because Hydrobond is a non-silicone based adhesive in water emulsion, higher bonding strength of MF-606 to Hydrobond is probably due to the less hydrophobic nature of MPDS. The improved properties of MPDS-MF are related to its chemical structure. The polydimethysiloxane polymer MPDS provides the silicone elastomer characteristics. The dimethacrylate groups located on the chain ends readily undergo

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J.H. Lai et al. / Dental Materials 18 (2002) 281286 [3] Lontz JF. State-of-the-art materials used for maxillofacial prosthetic reconstruction. Dental Clinics of North America 1990;34(2):30725. [4] Andres C. Survey of materials used in extra-oral maxillofacial prosthetics. Proceedings of Materials Research in Maxillofacial Prosthetic Academy of Dental Materials, Chicago, IL, 1992. [5] Haug SP, Andres CJ, Munoz CA, Okamura M. Effects of environmental factors on maxillofacial elastomersPart III: physical properties. J Prosthet Dent 1992;68:64451. [6] Sanchez RA, Moore DJ, Cruz DL, Chappell R. Comparison of the physical properties of two types of polydimethyl siloxane for fabrication of facial prostheses. J Prothet Dent 1992;67:67982. [7] Andres CJ, Haug SP, Brown DT, Bernal G. Effects of environmental factors on maxillofacial elastomersPart II: report of survey. J Prosthet Dent 1992;68:51922. [8] ASTM Designation: D 2240-86, Standard test method for rubber propertydurometer hardness. [9] ASTM Designation: D 412-92, Standard test method for rubber properties in tension. [10] ASTM Designation: D 1938-92, Standard test method for tear propagation resistance of plastic lm and thin sheeting by a single-tear method. [11] ASTM Designation: D 903-93 Standard test method for peel or stripping strength of adhesive bonds. [12] Wright PS. Characterization and Adhesion of Soft Lining Materials to Poly (methyl Methacrylate). J Den Res 1982;61(8):10025. [13] Lai JH, Hodges JS. Effects of processing parameters on physical properties of the silicone maxillofacial prosthetic materials. Dent Mat 1999;15:4505.

free-radical thermal polymerization and crosslinking. Presence of methacrylate groups in the polymer network enhances the tear strength, tensile strength, bonding strength to the adhesives and the dispersibilty with the pigments. The results obtained from the present study suggest that MPDS-MF is suitable for use as a maxillofacial prosthetic material. Preliminary clinical evaluation of prostheses made from MPDS-MF has been completed and will be reported in the future. Acknowledgements This investigation was supported in part by Research Grants DE11076 and P30-DE09737 from National Institute of Dental and Craniofacial Research, Bethesda, MD 20892, USA. References
[1] Lewis DH, Castleberry DJ. An assessment of recent advances in external maxillofacial materials. J Prosthet Dent 1980;43:42632. [2] Craig RG. Maxillofacial prostheses. In: Williams D, editor. Concise encyclopedia of medical and dental materials, Cambridge, MA: The MIT Press, 1990.

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