CORE--BIOCOMPATIBILITY

描述(由申请人提供)：生物相容性核心的目标 是为所有牙科患者提供完整的临床前生物兼容性测试 在计划项目中生产的树脂和复合材料以及所有新的 用于编制方案项目材料的化学品。具体地说 具体目标是：1)执行标准的体外测试，以评估 细胞毒性和致突变性；2)进行额外的体外测试 将在内分泌水平提供更广泛的生物兼容性评估 从成分中提取的干扰活性和促炎活性 用于项目项目中的树脂和复合材料的制备；3) 在实验动物身上进行体内测试以确定刺激性， 对该计划感兴趣的材料的敏化和亚慢性毒性 项目；4)通过分析确定可浸出成分 计划项目中准备的牙科树脂萃取物。全 生物兼容性测试将在良好的实验室操作规范下进行 (GLP)，以支持人体最终产品的临床研究。标准测试 将按照针对表面接触设备和AS的建议执行 在ISO 7405和ANSI/ADA文件41中指定。附加的体外试验 依赖ICSM-1的免疫毒性测试等测试是在 过去资助期间的计划项目，现在已成为 生物相容性核心活动。标准测试也将应用于材料 已经固化不足，以评估潜在的误用导致 生物不相容。我们预计平均每年检测16个样本。 样品包括新的聚合物材料(树脂或复合材料)，全部是新的 组分和参比化合物。在体内测试将增加在 该计划项目的后期阶段。生物相容性的意义 核心活动是单个部件和组装的牙科 胶粘剂和复合材料系统将具有定义明确、法规可接受、 临床使用前的生物兼容性，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.