Department of Conservative Dentistry, University of Regensburg, Franz-Josef-Strauss-Allee 11, 93053 Regensburg, Germany; Department of Preventive, Restorative and Pediatric Dentistry, University of Bern, Freiburgstrasse 7, CH-3010 Bern, Switzerland.
Department of Conservative Dentistry, University of Regensburg, Franz-Josef-Strauss-Allee 11, 93053 Regensburg, Germany.
Dent Mater. 2017 Apr;33(4):382-393. doi: 10.1016/j.dental.2017.01.011. Epub 2017 Feb 21.
Biocompatibility of dental materials has gained increasing interest during recent decades. Meanwhile, legal regulations and standard test procedures are available to evaluate biocompatibility. Herein, these developments will be exemplarily outlined and some considerations for the development of novel materials will be provided.
Different aspects including test selection, release of substances, barriers, tissue healing, antibacterial substances, nanoparticles and environmental aspects will be covered. The provided information is mainly based on a review of the relevant literature in international peer reviewed journals, on regulatory documents and on ISO standards.
Today, a structured and systematic approach for demonstrating biocompatibility from both a scientific and regulatory point of view is based on a clinical risk assessment in an early stage of material development. This includes the analysis of eluted substances and relevant barriers like dentin or epithelium. ISO standards 14971, 10993, and 7405 specify the modes for clinical risk assessment, test selection and test performance. In contact with breached tissues, materials must not impair the healing process. Antibacterial effects should be based on timely controllable substances or on repellant surfaces. Nanoparticles are produced by intraoral grinding irrespective of the content of nanoparticles in the material, but apparently at low concentrations. Concerns regarding environmental aspects of mercury from amalgam can be met by amalgam separating devices. The status for other materials (e.g. bisphenol-A in resin composites) needs to be evaluated. Finally, the public interest for biocompatibility issues calls for a suitable strategy of risk communication.
A wise use of the new tools, especially the clinical risk assessment should aim at preventing the patients, professionals and the environment from harm but should not block the development of novel materials. However, biocompatibility must always be weighed against the beneficial effects of materials in curing/preventing oral diseases.
近几十年来，牙科材料的生物相容性越来越受到关注。与此同时，已有可用的法律规定和标准测试程序来评估生物相容性。本文将举例说明这些进展，并为新型材料的开发提供一些考虑因素。
涵盖了不同的方面，包括测试选择、物质释放、屏障、组织愈合、抗菌物质、纳米颗粒和环境方面。所提供的信息主要基于对国际同行评议期刊、法规文件和 ISO 标准中相关文献的综述。
如今，从科学和监管角度证明生物相容性的结构化和系统方法是基于材料开发早期的临床风险评估。这包括对洗脱物质和相关屏障（如牙本质或上皮）的分析。ISO 标准 14971、10993 和 7405 规定了临床风险评估、测试选择和测试性能的模式。与受损组织接触时，材料不得损害愈合过程。抗菌效果应基于及时可控的物质或排斥表面。纳米颗粒是由口腔内研磨产生的，与材料中的纳米颗粒含量无关，但显然浓度很低。可以通过汞合金分离装置来解决汞合金的环境方面问题。其他材料（如树脂复合材料中的双酚 A）的情况需要进行评估。最后，公众对生物相容性问题的关注需要制定适当的风险沟通策略。
明智地使用新工具，特别是临床风险评估，应旨在防止患者、专业人员和环境受到伤害，但不应阻止新型材料的开发。然而，生物相容性必须始终与材料在治疗/预防口腔疾病方面的有益效果相权衡。
