Influence of Pigments and Opacifiers on Color Stability of an Artificially Aged Facial Silicone

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Effect of Disinfection and Accelerated Aging on Color Stability of Colorless and Pigmented Facial Silicone

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Color Stability Comparison of Silicone Facial Prostheses Following Disinfection

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Visual evaluation of color stability after accelerated aging of pigmented and nonpigmented silicones to be used in facial prostheses

Objectives: The objective of this study was to evaluate by a visual method of comparison the color stability of nonpigmented and pigmented facial silicones after accelerated aging. Materials and Methods: Two kinds of silicones were used in this study; one specifically formulated for facial prostheses and the other an acetic silicone for industrial use. Twenty-four trial bodies were made for each silicone. These were divided into colorless and intrinsically pigmented groups: ceramic, make-up, and iron oxide. The groups were submitted to accelerated aging for nonmetallic materials. An initial reading and subsequent readings were made at 163, 351, 692, and 1000 hours using a visual method of comparison. The values were annotated in a spreadsheet by two observers, according to scores elaborated for this study. Results: All groups presented color stability in the visual method. According to the results obtained and analyzed in this study, we can conclude that both silicones, Silastic 732 RTV and Silastic MDX 4-4210, behaved similarly, they can therefore be indicated for use in maxillofacial prosthesis. The time factor of aging influenced negatively, independently of the pigmentation, or lack of it, and of silicones and no group had visually noticeable alterations in any of the accelerated aging time, independently of the addition or not of pigments.

Color stability after accelerated aging of two silicones, pigmented or not, for use in facial prostheses

One of the greatest challenges faced by buccomaxillofacial prosthetists is to reproduce the patient's exact skin color and provide adequate esthetics. To reach this objective, professionals must use materials with easy characterization and that maintain color over long periods of time. The objective of this study was, thus, to evaluate the color stability of two types of silicones, Silastic 732 and Silastic MDX4-4210. Twenty-four test specimens were made from each type of silicone and were divided into a colorless group and groups intrinsically pigmented with ceramics, cosmetics or iron oxide. The specimens were submitted to an accelerated system of aging for non-metallic materials. Readings were carried out initially and after periods corresponding to 163, 351, 692 and 1,000 hours of aging, using a reflection spectrophotometer analysis, and color alterations were calculated by the CIE L*a*b* system. The data were submitted to variance analysis and Tukey's test at a 5% level of probability. The results demonstrated that, irrespective of the period of time analyzed, all the materials underwent some type of chromatic alteration (ΔE > 0). The test specimens made with Silastic 732 and MDX4-4210, without pigmentation, presented the lowest color alteration values after 1,000 hours of aging. Of the pigments, ceramic presented the lowest color alteration values and cosmetic powder presented the highest values. Thus, it may be concluded that the materials without the incorporation of pigments presented similar color alteration values, and did not differ statistically. The cosmetic powder used in this study was the pigment that most altered the color of the test specimens. © 2009 Sociedade Brasileira de Pesquisa Odontológica.

Evaluation of the Shore A Hardness of Silicone for Facial Prosthesis as to the Effect of Storage Period and Chemical Disinfection

The failure of facial prostheses is caused by limitations in the properties of existing materials, especially flexibility and durability. Therefore, this study evaluated the Shore A hardness of silicone used for fabrication of facial prostheses, Silastic MDX4-4210, according to the influence of storage period, daily disinfection, and 2 types of pigmentation. Thirty specimens were fabricated and divided in 3 groups: colorless, pigmented with makeup, and pigmented with iron oxide. Analysis of results was assessed on a Shore A hardness meter immediately, 6 months, and 1 year after fabrication of specimens, following the guidelines of the American Society for Testing and Materials. The hardness values were statistically analyzed by the Tukey test. The silicone exhibited an increase in hardness with time. However, the hardness was stable from 6 months to 1 year. It was concluded that the silicone is within the values of Shore A hardness reported in the literature, regardless of the storage period, pigmentation, and chemical disinfection.

Marginal deterioration of the silicone for facial prosthesis with pigments after effect of storage period and chemical disinfection

The failure of facial prostheses is caused by limitations in the properties of existing materials, especially flexibility and durability. Therefore, this study evaluated the marginal deterioration of a silicone used for fabrication of facial prostheses (Silastic MDX4-4210, Dow Corning Corporation, Midland, MI, USA) according to the influence of artificial aging, daily disinfection, and 2 types of pigmentation. Thirty specimens were fabricated and subdivided in 6 groups: without pigmentation, pigmented with make-up powder and iron oxide, and evaluated with and without the action of the disinfectant. Analysis of marginal deterioration was performed on a scanning electron microscope (magnification, ×5000) immediately 6 months and 1 year after fabrication of specimens, following the guidelines of ASTM International. After visual analysis of the photomicrographs, it was noticed that all groups presented marginal deterioration and alterations in surface texture with time. The use of disinfection did not contribute to the marginal deterioration of polymer (silicone), regardless of the pigmentation and artificial aging.

Membrane associated transporter protein gene (SLC45A2) and the genetic basis of normal human pigmentation variation

This work is concerned with the genetic basis of normal human pigmentation variation. Specifically, the role of polymorphisms within the solute carrier family 45 member 2 (SLC45A2 or membrane associated transporter protein; MATP) gene were investigated with respect to variation in hair, skin and eye colour ― both between and within populations. SLC45A2 is an important regulator of melanin production and mutations in the gene underly the most recently identified form of oculocutaneous albinism. There is evidence to suggest that non-synonymous polymorphisms in SLC45A2 are associated with normal pigmentation variation between populations. Therefore, the underlying hypothesis of this thesis is that polymorphisms in SLC45A2 will alter the function or regulation of the protein, thereby altering the important role it plays in melanogenesis and providing a mechanism for normal pigmentation variation. In order to investigate the role that SLC45A2 polymorphisms play in human pigmentation variation, a DNA database was established which collected pigmentation phenotypic information and blood samples of more than 700 individuals. This database was used as the foundation for two association studies outlined in this thesis, the first of which involved genotyping two previously-described non-synonymous polymorphisms, p.Glu272Lys and p.Phe374Leu, in four different population groups. For both polymorphisms, allele frequencies were significantly different between population groups and the 272Lys and 374Leu alleles were strongly associated with black hair, brown eyes and olive skin colour in Caucasians. This was the first report to show that SLC45A2 polymorphisms were associated with normal human intra-population pigmentation variation. The second association study involved genotyping several SLC45A2 promoter polymorphisms to determine if they also played a role in pigmentation variation. Firstly, the transcription start site (TSS), and hence putative proximal promoter region, was identified using 5' RNA ligase mediated rapid amplification of cDNA ends (RLM-RACE). Two alternate TSSs were identified and the putative promoter region was screened for novel polymorphisms using denaturing high performance liquid chromatography (dHPLC). A novel duplication (c.–1176_–1174dupAAT) was identified along with other previously described single nucleotide polymorphisms (c.–1721C>G and c.–1169G>A). Strong linkage disequilibrium ensured that all three polymorphisms were associated with skin colour such that the –1721G, +dup and –1169A alleles were associated with olive skin in Caucasians. No linkage disequilibrium was observed between the promoter and coding region polymorphisms, suggesting independent effects. The association analyses were complemented with functional data, showing that the –1721G, +dup and –1169A alleles significantly decreased SLC45A2 transcriptional activity. Based on in silico bioinformatic analysis that showed these alleles remove a microphthalmia-associated transcription factor (MITF) binding site, and that MITF is a known regulator of SLC45A2 (Baxter and Pavan, 2002; Du and Fisher, 2002), it was postulated that SLC45A2 promoter polymorphisms could contribute to the regulation of pigmentation by altering MITF binding affinity. Further characterisation of the SLC45A2 promoter was carried out using luciferase reporter assays to determine the transcriptional activity of different regions of the promoter. Five constructs were designed of increasing length and their promoter activity evaluated. Constitutive promoter activity was observed within the first ~200 bp and promoter activity increased as the construct size increased. The functional impact of the –1721G, +dup and –1169A alleles, which removed a MITF consensus binding site, were assessed using electrophoretic mobility shift assays (EMSA) and expression analysis of genotyped melanoblast and melanocyte cell lines. EMSA results confirmed that the promoter polymorphisms affected DNA-protein binding. Interestingly, however, the protein/s involved were not MITF, or at least MITF was not the protein directly binding to the DNA. In an effort to more thoroughly characterise the functional consequences of SLC45A2 promoter polymorphisms, the mRNA expression levels of SLC45A2 and MITF were determined in melanocyte/melanoblast cell lines. Based on SLC45A2’s role in processing and trafficking TYRP1 from the trans-Golgi network to stage 2 melanosmes, the mRNA expression of TYRP1 was also investigated. Expression results suggested a coordinated expression of pigmentation genes. This thesis has substantially contributed to the field of pigmentation by showing that SLC45A2 polymorphisms not only show allele frequency differences between population groups, but also contribute to normal pigmentation variation within a Caucasian population. In addition, promoter polymorphisms have been shown to have functional consequences for SLC45A2 transcription and the expression of other pigmentation genes. Combined, the data presented in this work supports the notion that SLC45A2 is an important contributor to normal pigmentation variation and should be the target of further research to elucidate its role in determining pigmentation phenotypes. Understanding SLC45A2’s function may lead to the development of therapeutic interventions for oculocutaneous albinism and other disorders of pigmentation. It may also help in our understanding of skin cancer susceptibility and evolutionary adaptation to different UV environments, and contribute to the forensic application of pigmentation phenotype prediction.

Functional outcome and usage of the prosthesis of lower limb amputees fitted with osseointegrated fixation

This study established that the core principle underlying categorisation of activities have the potential to provide more comprehensive outcomes than the recognition of activities because it takes into consideration activities other than directional locomotion.

Vitamin D intake needed to maintain target serum 25-Hydroxyvitamin D concentrations in participants with low sun exposure and dark skin pigmentation is substantially higher than current recommendations

Cutaneous cholecalciferol synthesis has not been considered in making recommendations for vitamin D intake. Our objective was to model the effects of sun exposure, vitamin D intake, and skin reflectance (pigmentation) on serum 25-hydroxyvitamin D (25[OH]D) in young adults with a wide range of skin reflectance and sun exposure. Four cohorts of participants (n = 72 total) were studied for 7-8 wk in the fall, winter, spring, and summer in Davis, CA [38.5° N, 121.7° W, Elev. 49 ft (15 m)]. Skin reflectance was measured using a spectrophotometer, vitamin D intake using food records, and sun exposure using polysulfone dosimeter badges. A multiple regression model (R^sup 2^ = 0.55; P < 0.0001) was developed and used to predict the serum 25(OH)D concentration for participants with low [median for African ancestry (AA)] and high [median for European ancestry (EA)] skin reflectance and with low [20th percentile, ~20 min/d, ~18% body surface area (BSA) exposed] and high (80th percentile, ~90 min/d, ~35% BSA exposed) sun exposure, assuming an intake of 200 IU/d (5 ug/d). Predicted serum 25(OH)D concentrations for AA individuals with low and high sun exposure in the winter were 24 and 42 nmol/L and in the summer were 40 and 60 nmol/L. Corresponding values for EA individuals were 35 and 60 nmol/L in the winter and in the summer were 58 and 85 nmol/L. To achieve 25(OH)D ≥75 nmol/L, we estimate that EA individuals with high sun exposure need 1300 IU/d vitamin D intake in the winter and AA individuals with low sun exposure need 2100-3100 IU/d year-round.

Evaluation framework to assess benefits and harms of bone-anchored prosthesis

Bone-anchored prostheses are increasingly acknowledged as viable alternative method of attachment of artificial limb compared to socket-suspended prostheses. To date, a few osseointegration fixations are commercially available. Several devices are at different stages of development particularly in Europe and the US. Clearly, the current momentum experienced worldwide is creating a need for a standardized evaluation framework to assess the benefits and safety of each procedure.

Health-related quality of life of individuals with transfemoral amputation fitted with the Transcutaneous Bone Anchoring Prosthesis following the OGAAP

The benefits and safety transcutaneous bone anchored prosthesis relying on a screw fixation are well reported. However, most of the studies on press-fit implants and joint replacement technology have focused on surgical techniques. One European centre using this technique has reported on health-related quality of life (HRQOL) for a group of individuals with transfemoral amputation (TFA). Data from other centres are needed to assess the effectiveness of the technique in different settings. The aim of this study is to report HRQOL data at baseline and up to 2-year follow-up for a group of TFAs treated by Osseointegration Group of Australia who followed the Osseointegration Group of Australia Accelerated Protocol (OGAAP), in Sydney between 08/12/2011 and 09/04/2014.