Cariology, Restorative Sciences, and Endodontics, School of Dentistry, University of Michigan, Ann Arbor, MI 48109-1078, United States.
Dent Mater. 2012 Jan;28(1):52-71. doi: 10.1016/j.dental.2011.08.594.
Review correlations of in vivo clinical performance with in vitro laboratory tests of restorative dental materials involving polymer-based matrices. Identify those factors interfering with the process.
An evidence-based dentistry approach was used to identify clinical trials, critical reviews, and meta-analyses involving correlations. Factors impacting meaningful correlations were reviewed. The limited bona fide correlations were reviewed.
In vitro tests include physical, chemical, mechanical, and biological properties. Clinical research measurements routinely include 10-15 categories of clinical observations of performance such as color match, caries resistance, marginal integrity, surface texture, and others, but do not correspond well with laboratory properties. Clinical trials of restorative dental materials represent a small fraction of the total research in this arena (typically <10% of dental materials research over many years). Trials are generally short-term (2-5 years) and are designed primarily to test product "safety and efficacy." A large number of risk factors (operator, design, material, intraoral location, patient) affect clinical outcomes and are not simulated well in laboratories. Little long-term information exists for clinical performance other than on composite wear. Very few meaningful correlations of laboratory tests and clinical results are demonstrated.
CONCLUSIONS/RECOMMENDATIONS: New studies should be focused on recovering restorations from service and characterizing them with the same tests as normally conducted in the laboratory. Many more long-term clinical trials that involve 10-20 years of observations are needed. Those trials should include planned restoration recovery to assess changes in laboratory properties of interest.
回顾涉及聚合物基质的修复牙科材料的体内临床性能与体外实验室测试的相关性。确定干扰该过程的因素。
采用循证牙科方法，确定涉及相关性的临床试验、关键评价和荟萃分析。审查了影响有意义相关性的因素。还审查了有限的真实相关性。
体外测试包括物理、化学、机械和生物学特性。临床研究测量通常包括 10-15 种性能观察类别，如颜色匹配、抗龋性、边缘完整性、表面纹理等，但与实验室性能不太对应。修复牙科材料的临床试验仅占该领域总研究的一小部分（多年来通常不到牙科材料研究的 10%）。试验通常是短期的（2-5 年），主要旨在测试产品的“安全性和有效性”。大量风险因素（操作人员、设计、材料、口腔内位置、患者）影响临床结果，在实验室中无法很好地模拟。除了复合材料磨损外，关于临床性能的长期信息很少。实验室测试和临床结果的相关性很少有意义。
结论/建议：新的研究应集中在从服务中恢复修复体，并使用与实验室正常进行的相同测试对其进行特征描述。需要进行更多涉及 10-20 年观察的长期临床试验。这些试验应包括计划恢复以评估感兴趣的实验室性能变化。
