Biocompatibility

生物相容性

• 批准号: 6443106
• 负责人: Edward J Boland
• 金额: $ 16.21万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-06-01 至 2007-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6443106
• 关键词: biomaterial compatibility; biomaterial evaluation; cell line; composite resins; cytokine; dental pulp; dentin; ferrets; genetically modified animals; guinea pigs; hamsters; human tissue; laboratory mouse; odontoblasts

DESCRIPTION: (provided by applicant): The objective of the biocompatibility core is to identify risks associate with the exposure of the biological tissues and cells to new resin based restorative materials and/or their components as they are developed. The biocompatibility core will utilize both in vitro and in vivo tests in order to characterize both the risks and hazards associated with the new resin based restorative materials. In specific aim 1, initial testing for biocompatibility will be accomplished using in vitro culture methods employing mouse odontoblast and dental pulp cell lines, using survival as the end point parameter. Cell survival will be determined using the WST-1 and LDH assay systems. Assessment of both risk (bioactivity) and hazard (bioavailability) potential will be accomplished through indirect exposure of the cell monolayer to test substances. The goal of specific aim 1 is to identify component substances of newly developed resin based restorative materials that may be potential risks. An additional goal is the identification of new response parameters that may improve the correlation between in vitro evaluation and in vivo analysis. Thus, the expression of cytokines by human dental cell lines will be evaluated using commercial DNA hybridization arrays to develop custom dental specific arrays. Promoters for selected cytokine gene products will also be legated to a luciferase reporter gene and stably transfected into human dental cell lines to develop sensitive, and specific assays. In specific aim 2, newly developed resin based restorative materials will be evaluated using in vivo assays, including stage one mutagenicity testing utilizing the Big Blue transgenic mouse system. Stage two tests evaluating mucous membrane irritation using the hamster cheek pouch and dermal sensitivity using the guinea pig will also be carried out. The goal of specific aim 2 is to evaluate the potential for in vivo toxicity of the material when in contact with the oral tissues, as well as to evaluate whether or not the new material is capable of producing an eczematous reaction. In specific aim 3, the newly developed resin based restorative material will be examined using an in vivo usage test designed to evaluate the material exactly as it is intended to be used clinically. The goal of this aim is to evaluate the effects of the material on underlying dentin and pulp. The test will be accomplished using the ferret as the animal model system. This mammal has been shown to be a suitable model system for assessing the effects of dental procedures and materials on pulp and dentin.

描述：（由申请人提供）：生物相容性的目标 核心是识别与生物组织暴露相关的风险 和细胞到新的树脂基修复材料和/或其组件 他们是发达的。生物相容性核心将在体外和体内利用 体内测试，以描述与相关的风险和危害 新型树脂基修复材料。在具体目标 1 中，初步测试 生物相容性将通过体外培养方法来实现 采用小鼠成牙本质细胞和牙髓细胞系，以存活率作为 终点参数。将使用 WST-1 和 LDH 确定细胞存活率 化验系统。风险（生物活性）和危害评估 （生物利用度）潜力将通过间接暴露来实现 细胞单层来测试物质。具体目标 1 的目标是 鉴定新开发的树脂基修复体的成分物质 可能存在潜在风险的材料。另一个目标是识别 新的响应参数可以改善体外之间的相关性 评估和体内分析。因此，人类细胞因子的表达 牙科细胞系将使用商业 DNA 杂交阵列进行评估 开发定制牙科专用阵列。选定细胞因子基因的启动子 产品还将与荧光素酶报告基因相关并稳定地 转染到人类牙细胞系中以开发敏感的、特异性的 化验。具体目标2，新开发的树脂基修复材料 将使用体内测定进行评估，包括第一阶段致突变性 利用 Big Blue 转基因小鼠系统进行测试。第二阶段测试 使用仓鼠颊囊和真皮评估粘膜刺激 还将使用豚鼠进行敏感性测试。具体目标 目标 2 是评估材料在体内的潜在毒性 与口腔组织的接触，以及评估新的是否 材料能够产生湿疹反应。在具体目标 3 中， 新开发的树脂基修复材料将使用 in vivo 使用测试旨在准确评估材料的用途 应用于临床。该目标的目的是评估 下面的牙本质和牙髓上的材料。测试将使用以下方法完成 雪貂作为动物模型系统。这种哺乳动物已被证明是合适的 用于评估牙科手术和材料对患者的影响的模型系统 牙髓和牙本质。