EVALUATION OF TISSUE REACTION WITH USAGE OF PIGMENTED NANO-FILLED SILICONE ELASTOMER (A-2000)

Maxillofacial prostheses, such as silicone elastomers, are crucial for reconstructing congenital or acquired defects to help patients lead normal lives. However, long-term tissue reactions to these materials remain debated despite their effectiveness.Objectives: This study aimed to assess the tissue reaction on intrinsically pigmented nano-filled platinum based silicone elastomer A-2000.Methodology: 54 intrinsically pigmented biomedical silicone elastomers (A-2000) samples were evaluated for cell reaction, where the Human Gingival Fibroblasts were subjected to cell viability in which cell lines were isolated from human gingival keratinized tissue and then seeded in wells, to achieve the evidence of cell viability in response to the cured silicone elastomer (A-2000) when silicone is intrinsically pigmented through MTT assay indirectly assess the silicone samples to see their effect on cell viability. Results A one-way ANOVA revealed significant differences among all study groups at all-time intervals (p = 0.001). At 24 hours, the RG group differed significantly from both the control and TG groups (p < 0.001), and the control group differed from the TG group (p = 0.003). At 48 hours, significant differences were found between the control group and both the RG (p = 0.020) and TG groups (p = 0.004). At 72 hours, a significant difference was observed only between the control and RG groups (p = 0.001).Conclusion: Decreased cell viability was consistently observed throughout the incubation intervals, with statistically significant differences detected within an acceptable range.