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Statement of Problem: Maxillofacial prostheses are serviceable for approximately 6 months, after which they need to be refabricated because of the deterioration of color and physical properties., Purpose: This third article in a 3-part series evaluated the color stability of commonly used colorant-elastomer combinations as a result of exposure to weathering., Methods and Material: Fifteen specimens were fabricated for each of the 3 elastomers (Silastic medical adhesive type A, Silastic 4-4210, and Silicone A-2186) and 6 colorants (dry earth pigments, rayon fiber flocking, artist's oil paints, kaolin, liquid cosmetics, and no colorant) for a total of 270 specimens (18 groups of 15 specimens). The 15 specimens of each elastomer-colorant combination were separated into 3 test condition groups (control, time passage, and natural weathering) of 5 specimens per test condition group. Control specimens were evaluated within 1 month of fabrication. The time passage group was sealed in glass containers and kept in the dark for 6 months before testing. The natural weathering groups were placed on the roof of the dental school for 6 months and exposed to sunlight and weathering. Color and optical density data for each elastomer-colorant combination were subjected to a 1-way analysis of variance to examine effects among test conditions (control, time passage, and weathering). When significant differences were observed, the Student-Newman-Keuls multiple range test was performed to identify differences in elastomer-colorant combinations among each test condition at a significance level of .05., Results: Changes in color, as a result of weathering, were noted in many of the colorant-elastomer combinations. Also, color change occurred not only to the colored, but also to uncolored materials over time without exposure to weathering., Conclusion: Clinically, the addition of colorants could have a stabilizing effect on the elastomer color when it is exposed to weathering.

Statement of Problem: The average clinical life span of a maxillofacial prosthesis is approximately 6 months, at which point it needs to be refabricated, mainly because of degradation of the color and physical properties of the prosthesis., Purpose: This first part of a 3-part study evaluated the effect of coloring agents on the physical properties of maxillofacial elastomers., Methods and Material: Five dumbbell-shaped and 5 trouser-shaped specimens were fabricated for each of the combinations of the 3 elastomers (Silastic medical adhesive type A, Silastic 4-4210, and Silicone A-2186) and 6 colorants (dry earth pigments, rayon fiber flocking, artist's oil paints, kaolin, liquid cosmetics, and no-colorants), for a total of 180 specimens. Evaluations of hardness and tear strength were made with the trouser-shaped specimens. Evaluations of the ultimate tensile strength and the percentage elongation were made with the dumbbell-shaped specimens. A within elastomer analysis compared the 6 colorants using a 1-way analysis of variance for each of the 4 physical properties. When significant differences were observed, the Student-Newman-Keuls multiple range test was used to identify differences between groups at a significance level of.05., Results: Physical properties of maxillofacial elastomers were changed by the incorporation of coloring agents. Dry earth pigments, kaolin, and rayon flocking acted as a solid filler without bonding to the Silicone, and artists' oils and liquid cosmetics acted as a liquid phase without bonding to the silicone matrix., Conclusion: No clearly superior colorant-elastomer combination was demonstrated in all the tests in this study.

Statement of Problem: The clinical life of a maxillofacial prosthesis averages about 6 months, before it needs to be refabricated. Degradation of the color and physical properties of the prosthesis are the principle reasons for replacement., Purpose: This second part of a 3-part in vitro investigation evaluated the change in physical properties of popular colorant-elastomer combinations as a result of weather exposure., Material and Methods: Fifteen dumbbell-shaped and 15 trouser-shaped specimens were fabricated for each of the 3 elastomers (Silastic medical adhesive type A, Silastic 4-4210, and Silicone A-2186) and 6 colorant combinations (dry earth pigments, rayon fiber flocking, artist's oil paints, kaolin, liquid cosmetics, and no-colorants) for a total of 540 specimens. The 15 dumbbell-shaped and trouser-shaped specimens of each elastomer colorant combination were separated into 5 of each shape among 3 test condition groups (control, time passage, and natural weathering). Control specimens were evaluated within 1 month of fabrication. The time passage group was sealed in glass containers and kept in the dark for 6 months before testing. The natural-weathering groups were placed on the roof of the dental school for 6 months and exposed to sunlight and weathering. Evaluations of hardness and tear strength were made on trouser-shaped specimens, and evaluations of the ultimate tensile strength and percentage elongation on dumbbell-shaped specimens. Physical property data for each elastomer-colorant combination were subjected to a 1-way analysis of variance to examine effects among the test conditions. When significant differences were observed, the Student-Newman-Keuls multiple range test was performed to identify differences in elastomer-colorant combinations among each test condition at a significance level of .05., Results: Exposure to weathering and time changes of the physical properties of many colorant-elastomer combinations indicated that properties of a clinical prosthesis can change with time., Conclusion: The addition of colorants to the silicones altered the effects of weathering. In addition, the silicones were not as stable as previously assumed.

Purpose: To determine if using CIE L*a*b* color measurements of white facial skin could be correlated to those of silicone shade samples that visually matched the skin. Secondly, to see if a correlation in color measurements could be achieved between the silicone shade samples and duplicated silicone samples made using a shade-guide color formula., Materials and Methods: A color booth was designed according to ASTM specifications, and painted using a Munsell Value 8 gray. A Minolta colorimeter was used to make facial skin measurements on 15 white adults. The skin color was duplicated using custom-shaded silicone samples. A 7-step wedge silicone shade guide was then fabricated, representing the commonly encountered thicknesses when fabricating facial prostheses. The silicone samples were then measured with the Minolta colorimeter. The readings were compared with the previous L*a*b* readings from the corresponding patient's skin measurements, and the relative color difference was then calculated. Silicone samples were fabricated and analyzed for three of the patients to determine if duplication of the visually matched silicone specimen was possible using the silicone color formula, and if the duplicates were visually and colorimetrically equivalent to each other. The color difference Delta E and chromaticity was calculated, and the data were analyzed using a coefficient-of-variation formula expressed by percent. A Pearson Product Moment Correlation Coefficient was performed to determine if a correlation existed between the skin and the silicone samples at the p < or = .05 level., Results: The highest correlation was found in the b* dimension for silicone thicknesses of 1 to 4 mm. For silicone thicknesses of 6 to 10 mm, the highest correlation was found in the L* dimension. All three dimensions had positive correlations (R2 > 0), but only the 1-mm and 4-mm b* readings were very strong. Patient and silicone L*a*b* measurement results showed very little change in the a* axis, while the L* and b* measurements showed more change in their numbers, with changes in depth for all patient silicone samples. Delta E numbers indicated the lowest Delta E at the 1-mm depth and the highest Delta E at the 10-mm depth. All duplicated samples matched their original silicone samples to a degree that visual evaluation could not distinguish any color differences. Using volumetric measurements, a shade guide was developed for all 15 patients., Conclusions: There was good correlation between the patient's colorimeter measurements and the silicone samples, with the b* color dimension the most reproducible, followed by the L* and the a*. Silicone samples at 6, 8, and 10 mm matched the patient the best, and this study showed that silicone samples can be duplicated successfully if a good patient-silicone match is obtained. Rayon flocking fibers and liquid makeup are effective at matching facial prostheses and can be used to develop a simple shade guide for patient application.

Part II of a four-part report presents an international survey that was conducted to determine the most frequently used materials in the fabrication of facial and somatoprostheses. The survey also solicited information about advantages and disadvantages, methods of coloring, and the perceived properties of an "ideal" material. The results of the survey indicated that the majority of prosthodontists and prosthetists are using room temperature-vulcanized silicone products, intrinsically colored with dry earth pigments or artist's pigments. The need for further research in materials for external prostheses was clearly indicated.

Part I of a four-part report presents a comprehensive review of the literature pertaining to physical property testing of materials for facial and somatoprostheses. The report was conducted in preparation for testing four current maxillofacial elastomers: MDX 4-4210, Silastic 4-4515, Medical Adhesive type A, and Epithane-3, and two recently introduced materials: Silicone A-2186 and Silicone A-102.