Clinically-calibrated Accelerated Fatigue Test for Predicting the Clinical Performance of Dental Restorative Materials

项目摘要/摘要 现在迫切需要开发更多与临床相关的测试，或医疗设备开发 工具(MDDT)，作为临床研究的替代方案，帮助加快新牙科的翻译 材料。在R61/R33两相应用中，我们提出了加速疲劳形式的MDDT 通过临床数据校准的测试，用于评估树脂复合材料的临床性能。方法 明确预测复合修复体的存活概率作为时间的函数，通过一些 一种简单但具有临床代表性的模型复合材料的易于执行的循环疲劳和生物膜测试 修复。我们的近期目标是让这种MDDT获得fda的资格，用于牙科材料。 虽然我们的长期目标是将此工具的方法和应用扩展到其他 医疗器械。我们对拟议的MDDT进行资格审查的战略包含以下具体目标： 阶段1，目标1确认模型树脂-复合材料修复体的加速疲劳试验的重复性。 使用常规材料的疲劳试验将重复多次。随之而来的生存 概率曲线预计位于彼此的95%区间内。 阶段1，目标2评估用于产生复发的校准生物膜模型的生存能力和重复性 去骨标本中的龋齿。解除粘合的标本将使用临床校准的 生物膜模型。复发的龋齿预计在样本和临床上是一致的。 可以在所需的置信度区间内预测脱粘之后发生脱粘的时间。 阶段2，目标3确定实验室模型是否可以准确地预测广泛范围的 使用前瞻性临床数据的复合修复体。不同类型肺癌的前瞻性临床数据 将收集修复材料，用于实验室模型的校准和验证。校准后的模型 预计能够准确预测不同类别修复体的临床表现。 阶段2，目标4确定实验室模型是否可以准确地预测广泛范围的 使用回顾性临床数据进行复合修复体。将从以下地点收集回顾临床数据 大茅斯牙科数据仓库，以进一步验证该模型的寿命预测。重新校准了 预计模型仍能准确预测修复体的使用寿命。 第二阶段，目标5评估加速疲劳和生物膜试验的可行性和重复性 具有防龋性和再矿化性的树脂复合材料。由材料制成的标本 无论是否具有抗菌性能，都将使用校准的疲劳和生物膜模型进行挑战。 含有抗菌剂的树脂复合材料预计需要更长的时间才能发展为复发的龋齿，以及 结果是可重复的。

Project Summary/Abstract There is now an urgent need to develop more clinically relevant tests, or medical device development tools (MDDT), that are alternatives to clinical studies to help accelerate the translation of new dental materials. In this biphasic R61/R33 application, we propose a MDDT, in the form of an accelerated fatigue test calibrated by clinical data, for assessing the clinical performance of resin composites. The method explicitly predicts the survival probability of composite restorations as a function of time, through some easy-to-perform cyclic fatigue and biofilm tests on a simple yet clinically representative model composite restoration. Our immediate goal is to have this MDDT qualified by the FDA for use by dental materials manufacturers, while our long-term goal is to extend the method and application of this tool to other medical devices. Our strategy for qualifying the proposed MDDT contains the following specific aims: Phase 1, Aim 1 Confirm repeatability of accelerated fatigue test for model resin-composite restorations. The fatigue test using conventional materials will be repeated multiple times. The resulting survival probability curves are expected to lie within the 95% interval of each other. Phase 1, Aim 2 Assess viability and repeatability of calibrated biofilm model for producing recurrent caries in debonded specimens. Debonded specimens will be challenged using a clinically-calibrated biofilm model. Recurrent caries is expected to be produced consistently in the specimens and the clinical time for it to occur following debonding can be predicted within the required confidence intervals. Phase 2, Aim 3 Determine if laboratory model can accurately predict service life of a wide range of composite restorations using prospective clinical data. Prospective clinical data for different classes of restorations will be collected for calibration and validation of the laboratory model. The calibrated model is expected to be able to accurately predict the clinical performance of different classes of restorations. Phase 2, Aim 4 Determine if laboratory model can accurately predict service life of a wide range of composite restorations using retrospective clinical data. Retrospective clinical data will be collected from the BigMouth Dental Data Repository to further validate the model for life predictions. The recalibrated model is expected to be still capable of accurately predicting the service life of the restorations. Phase 2, Aim 5 Assess viability and repeatability of accelerated fatigue and biofilm tests for assessing resin composites with caries prevention and remineralization properties. Specimens made of materials with or without antibacterial properties will be challenged using the calibrated fatigue and biofilm models. Resin composites with antibacterial agents are expected to take longer to develop recurrent caries, and the results are repeatable.