사람구강점막모델 이용 안전성 평가를 위한 치과재료의 용출액 분석

Abstract

Various methods of the extraction test is currently available for the biological safety evaluation of dental materials. Hence, setting of the appropriate extraction conditions such as extraction media appropriate to the materials, extraction temperature, and extraction time would be required. In this study, analysis of the dental materials that is used while in contact with oral mucosa was carried out in term of their selections, sample preparations, extraction, in order to provide the foundation for the biological safety evaluation of medical devices that is alternative to the animal studies. Dental materials of restorative composite resin, chemical cured denture base resin, and polyvinyl siloxane impression materials were selected and the SPU-ZDEC (Zinc diethyldithiocarbamate) was used as the positive control. They were all extracted according to the ISO 10993-12. Visual inspection, pH meter, Ultimate 3000 UHPLC, UltraflexⅢ TOF/TOF, and UPLC were used as the method of extracted solution analysis. As the results, there was no foreign materials nor impurities in all of test samples during visual inspection of the appearance. The pH was near the neutral value of 7, except for the restorative composite resin and the blank test solution. Finally, the detailed analysis of extracted solution showed evidence of main components of materials such as bisphenol A glycerolate dimethacrylate, diurethane dimethacrylate, triethylene glycol dimethacrylate, and zinc diethyldithiocarbamate. The result of this study will provide useful information on safety evaluation of tested materials including the sample preparation method for the alternative test method to animal study such as mucosa irritation test.