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

用于预测牙科修复材料临床性能的临床校准加速疲劳测试

• 批准号: 10738667
• 负责人: Alex Siu-Lun Fok
• 金额: $ 30.38万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-18 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10738667
• 关键词: Acceleration; Anti-Bacterial Agents; Biocompatible Materials; Biological; Calibration; Caries prevention; Chemicals; Clinical; Clinical Data; Clinical Research; Composite Dental Resin; Composite Resins; Confidence Intervals; Data; Dental; Dental Materials; Dental caries; Dentin; Dentists; Evaluation; Failure; Fatigue; Goals; Guidelines; In Situ; Laboratories; Life; Manufacturer; Marketing; Medical Device; Methods; Microbial Biofilms; Modeling; Notification; Patients; Performance; Periodicity; Phase; Preparation; Probability; Process; Property; Qualifying; Recurrence; Regulatory Pathway; Services; Specimen; Testing; Therapeutic Equivalency; Time; Translations; United States Food and Drug Administration; Validation; clinical predictors; clinical translation; clinically relevant; combat; composite restoration; cost; data repository; demineralization; improved; interfacial; mechanical properties; prospective; remineralization; restoration; restorative dentistry; restorative material; survival prediction; tool; tool development

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.

项目总结/摘要 现在迫切需要开发更多临床相关的测试，或者说医疗设备开发 工具（MDDT），这是临床研究的替代品，以帮助加快新的牙科翻译 材料.在该双相R61/R33应用中，我们提出了一种加速疲劳形式的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。述的方法 明确预测的生存概率的复合替代作为时间的函数，通过一些 在简单但具有临床代表性的模型复合材料上进行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通过FDA认证，用于牙科材料。 虽然我们的长期目标是将这种工具的方法和应用扩展到其他制造商， 医疗器械我们对拟议MDDT进行资格认证的策略包含以下具体目标： 第1阶段，目标1确认模型树脂复合材料修复体加速疲劳测试的可重复性。 使用常规材料的疲劳试验将重复多次。最终的生存 期望概率曲线位于彼此的95%区间内。 第1阶段，目的2评估校准生物膜模型的可行性和可重复性，以产生复发性 脱粘标本中的龋齿。将使用临床校准的 生物膜模型复发性龋预计将产生一致的标本和临床 可以在所需的置信区间内预测在剥离之后其发生的时间。 第2阶段，目标3确定实验室模型是否可以准确预测各种 使用前瞻性临床数据的复合解释。不同类别的前瞻性临床数据 将收集数据，用于实验室模型的校准和验证。校准的模型 预计能够准确预测不同类别的预防措施的临床表现。 第2阶段，目标4确定实验室模型是否可以准确预测各种 使用回顾性临床数据进行复合分析。回顾性临床数据将收集自 BigMouth Dental数据库，以进一步验证寿命预测模型。重新校准的 预计模型仍然能够准确预测修复体的使用寿命。 第2阶段，目标5评估加速疲劳和生物膜试验的可行性和可重复性，以评估 具有防龋和防龋性能的树脂复合材料。材料制成的样品 将使用校准的疲劳和生物膜模型来挑战具有或不具有抗菌性能的。 含有抗菌剂的树脂复合材料预计需要更长的时间才能形成复发性龋齿， 结果可重复。