IADR Abstract Archives
Biocompatibility of AllAccem Gingival Sealant, a New Prescription Dental Device
Objectives: AllAccem Gingival Sealant is in development as an aid in the treatment of gingivitis by inhibiting bacterial adhesion to tooth surfaces. The Sealant contains a proprietary polymer (012-38) that presents a surface barrier preventing oral bacteria forming dental plaque from adhering to and colonizing on tooth surfaces at the gingival margin and gingival sulcus. The objectives of the study were to evaluate the safety and biocompatibility of the Sealant.
Methods: 012-38 was tested in the bacterial reverse mutation assay against strain TA-100 in the presence and absence of S9. 012-38 was tested in guinea pigs for skin sensitization with repeated applications using the Buehler method. The induction phase utilized 10% w/v 012-38 and the challenge phase 5% w/v 012-38. 012-38 was tested in albino rabbits to assess the potential for dermal irritation. A 10% w/v solution of 012-38 was applied. Dermal reactions were scored at 1, 24, 48 and 72 hours following patch removal. To determine the potential for systemic toxicity, 012-38 was tested after single oral administration to rats. The rats were observed for 14 days and examined for gross pathology.
Results: 012-38 at 10 to 1000 μg/plate, with and without S9, did not cause a significant increase or dose-dependent increase of the number of revertants, indicating that 012-38 is negative for mutagenicity in the bacterial reverse mutation assay. In the skin sensitization assay, erythema was absent in both the induced group and the naive control group. 012-38 is not a dermal sensitizer in guinea pigs. In the skin irritation assay, the Primary Irritation Index was calculated as 0.44, therefore 10% w/v 012-38 is in the negligibly irritating response category. After oral administration to rats the LD50 is 2000 mg/kg.
Conclusions: In conclusion, biocompatibility and safety results indicate that AllAccem Gingival Sealant is safe to use as a prescription dental device.
Methods: 012-38 was tested in the bacterial reverse mutation assay against strain TA-100 in the presence and absence of S9. 012-38 was tested in guinea pigs for skin sensitization with repeated applications using the Buehler method. The induction phase utilized 10% w/v 012-38 and the challenge phase 5% w/v 012-38. 012-38 was tested in albino rabbits to assess the potential for dermal irritation. A 10% w/v solution of 012-38 was applied. Dermal reactions were scored at 1, 24, 48 and 72 hours following patch removal. To determine the potential for systemic toxicity, 012-38 was tested after single oral administration to rats. The rats were observed for 14 days and examined for gross pathology.
Results: 012-38 at 10 to 1000 μg/plate, with and without S9, did not cause a significant increase or dose-dependent increase of the number of revertants, indicating that 012-38 is negative for mutagenicity in the bacterial reverse mutation assay. In the skin sensitization assay, erythema was absent in both the induced group and the naive control group. 012-38 is not a dermal sensitizer in guinea pigs. In the skin irritation assay, the Primary Irritation Index was calculated as 0.44, therefore 10% w/v 012-38 is in the negligibly irritating response category. After oral administration to rats the LD50 is 2000 mg/kg.
Conclusions: In conclusion, biocompatibility and safety results indicate that AllAccem Gingival Sealant is safe to use as a prescription dental device.