Department of Restorative Dentistry, University of Washington, Seattle, WA 98195-7456, United States.
Dent Mater. 2012 Jan;28(1):23-40. doi: 10.1016/j.dental.2011.08.595.
Methods used to measure and predict clinical biological responses to dental materials remain controversial, confusing, and to some extent, unsuccessful. The current paper reviews significant issues surrounding how we assess the biological safety of materials, with a historical summary and critical look at the biocompatibility literature. The review frames these issues from a U.S. perspective to some degree, but emphasizes their global nature and universal importance.
The PubMed database and information from the U.S. Food and Drug Administration, International Standards Organization, and American National Standards Institute were searched for prominent literature addressing the definition of biocompatibility, types of biological tests employed, regulatory and standardization issues, and how biological tests are used together to establish the biological safety of materials. The search encompassed articles published in English from approximately 1965-2011. The review does not comprehensively review the literature, but highlights significant issues that confront the field.
Years ago, tests for biological safety sought to establish material inertness as the measure of safety, a criterion that is now deemed naive; the definition of biocompatibility has broadened along with the roles for materials in patient oral health care. Controversies persist about how in vitro or animal tests should be used to evaluate the biological safety of materials for clinical use. Controlled clinical trials remain the single best measure of the clinical response to materials, but even these tests have significant limitations and are less useful to identify mechanisms that shape material performance. Practice-based research networks and practitioner databases are emerging as important supplements to controlled clinical trials, but their final utility remains to be determined.
Today we ask materials to play increasingly sophisticated structural and therapeutic roles in patient treatment. To accommodate these roles, strategies to assess, predict, and monitor material safety need to evolve. This evolution will be driven not only by researchers and manufacturers, but also by patients and practitioners, who want to use novel materials in new ways to treat oral disease.
用于测量和预测牙科材料临床生物反应的方法仍然存在争议、令人困惑，并且在某种程度上是不成功的。本论文回顾了围绕我们如何评估材料生物安全性的重要问题，对生物相容性文献进行了历史总结和批判性分析。该综述从某种程度上以美国为视角，但强调了这些问题的全球性和普遍重要性。
在美国食品和药物管理局、国际标准化组织和美国国家标准协会的 PubMed 数据库和信息中搜索了有关生物相容性定义、所使用的生物学测试类型、监管和标准化问题以及如何将生物学测试一起用于建立材料生物安全性的突出文献。搜索涵盖了约 1965-2011 年期间用英语发表的文章。本综述并未全面回顾文献，而是重点介绍了该领域面临的重大问题。
多年前，生物安全性测试试图将材料惰性作为安全性的衡量标准，而现在这一标准被认为是幼稚的；随着材料在患者口腔保健中的作用扩大，生物相容性的定义也随之扩大。关于如何使用体外或动物测试来评估临床使用材料的生物安全性，仍然存在争议。对照临床试验仍然是评估材料临床反应的最佳方法，但即使这些测试也有很大的局限性，并且对于识别影响材料性能的机制用处不大。基于实践的研究网络和从业者数据库正在成为对照临床试验的重要补充，但它们的最终用途仍有待确定。
如今，我们要求材料在患者治疗中发挥越来越复杂的结构和治疗作用。为了适应这些角色，评估、预测和监测材料安全性的策略需要不断发展。这种演变不仅将由研究人员和制造商推动，还将由希望以新方式使用新型材料来治疗口腔疾病的患者和从业者推动。
