CORE--BIOCOMPATIBILITY

描述（由申请人提供）：生物相容性核心的目的 为所有牙科器械提供完整的临床前生物相容性测试， 树脂和复合材料生产的计划项目，以及所有新的 用于准备项目材料的化学品。特别是 具体目标是：1）进行标准体外试验，以评估 细胞毒性和致突变性; 2）进行额外的体外试验， 将在内分泌水平上提供更广泛的生物相容性评估 破坏活性和促炎活性， 用于制备树脂和复合材料的程序项目; 3） 在实验动物中进行体内试验以确定刺激性， 项目关注材料的致敏性和亚慢性毒性 项目;以及4）通过分析 在项目中制备的牙科树脂提取物。所有 生物相容性试验将根据药物非临床研究质量管理规范进行 (GLP)以支持最终产品在人体内的临床研究。标准测试 将按照表面接触器械的建议进行， 在ISO 7405和ANSI/ADA文件41中规定。额外的体外 ICSM-1依赖性免疫毒性试验等试验是在 在过去的资助期间，现在已经成为项目的一部分， 生物相容性核心活动。标准测试也将应用于材料 以评估潜在的误用， 生物不相容性我们预计每年平均测试16个样本。 样本包括新的聚合物材料（树脂或复合材料），所有新的 组分和参比化合物。体内试验将在 项目的后期阶段。生物相容性的意义 核心活动是单个组件和组装的牙科 粘合剂和复合材料系统将具有良好定义的，监管可接受的， 在临床使用之前，确保每个患者的安全性。

DESCRIPTION (provided by applicant): The objective of the Biocompatibility Core is to provide complete pre-clinical biocompatibility testing for all dental resins and composites produced in the program project as well as for all new chemicals used in preparation of program project materials. Specifically the specific aims are: 1) to perform standard in vitro tests for assessment of cytotoxicity and mutagenicity; 2) to perform additional in vitro testing that will provide broader biocompatibility assessment at the level of endocrine disrupting activity and pro-inflammatory activities derived from components used in the preparation of resins and composites in the program project; 3) to perform in vivo tests in experimental animals to establish the irritation, sensitization and subchronic toxicity of materials of interest to the program project; and 4) to determine leachable components through the analysis of extracts from dental resins prepared in the program project. All biocompatibility testing will be conducted under Good Laboratory Practices (GLP) to support clinical studies of final products in humans. Standard tests will be performed as recommended for surface contacting devices and as specified in the ISO 7405 and ANSI/ADA document 41. The additional in vitro tests such as the ICSM-1-dependent inmunotoxicity testing were developed in the program project during past funding periods and now have become part of the Biocompatibilty Core activity. Standard tests will also be applied to materials that have been under-cured so as to evaluate potential misuse leading to bio-incompatibility. We anticipate testing an average of 16 specimens per year. A specimen includes new polmeric material (resin or composite), all new components and reference compounds. In vivo testing will increase during the later stages of the program project. The significance of the Biocompatibility Core activities are that individual components and the assembled dental adhesive and composite systems will have a well defined, regulatory acceptable, biocompatibility prior to clinical use assuring the safety for each patient.