치과재료의 피부 감작성 평가를 위한 용출 시험 및 용출물 분석

Abstract

Skin sensitization is important test of biological evaluation in dental materials, where it is one of the frequently carried out test along with cytotoxicity and irritation test. The preparations of test materials and both positive and negative control materials are very important factor during the process of the test, while the extraction process of these materials are also need to be considered as most of the dental materials are extracted for the use as the test materials in skin sensitization test. This research focused on preparation of positive and negative materials, and also the actual dental materials made from metal or ceramics. Prepared materials were then extracted in appropriate solvent, extract temperature and durations. Finally, extracted liquids were analyzed for appearance, pH and chemical components in the extracted chemical. It is expected that provision of such extract method for dental materials along with preparation method of positive and negative control materials and analyses of them, would be helpful to both manufacturer and reviewer. They will provide improvements for medical device safety control, which would then linked to improvements of competencies in evaluators as well as providing safety for public health as the of primary consumer, medical 1) would enhance safety system professionals, as well as final consumer of public.