Fukuba Shunsuke, Okada Munehiro, Nohara Kohei, Iwata Takanori
Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo 113-8549, Japan.
Materials (Basel). 2021 Feb 26;14(5):1096. doi: 10.3390/ma14051096.
Various bone graft products are commercially available worldwide. However, there is no clear consensus regarding the appropriate bone graft products in different clinical situations. This review is intended to summarize bone graft products, especially alloplastic bone substitutes that are available in multiple countries. It also provides dental clinicians with detailed and accurate information concerning these products. Furthermore, it discusses the prospects of alloplastic bone substitutes based on an analysis of the current market status, as well as a comparison of trends among countries. In this review, we focus on alloplastic bone substitutes approved in the United States, Japan, and Korea for use in periodontal and bone regeneration. According to the Food and Drug Administration database, 87 alloplastic bone graft products have been approved in the United States since 1996. According to the Pharmaceuticals and Medical Devices Agency database, 10 alloplastic bone graft products have been approved in Japan since 2004. According to the Ministry of Health and Welfare database, 36 alloplastic bone graft products have been approved in Korea since 1980. The approved products are mainly hydroxyapatite, β-tricalcium phosphate, and biphasic calcium phosphate. The formulations of the products differed among countries. The development of new alloplastic bone products has been remarkable. In the near future, alloplastic bone substitutes with safety and standardized quality may be the first choice instead of autologous bone; they may offer new osteoconductive and osteoinductive products with easier handling form and an adequate resorption rate, which can be used with growth factors and/or cell transplantation. Careful selection of alloplastic bone graft products is necessary to achieve predictable outcomes according to each clinical situation.
全球范围内有多种骨移植产品可供商业使用。然而,对于不同临床情况下合适的骨移植产品尚无明确的共识。本综述旨在总结骨移植产品,特别是在多个国家都有的同种异体骨替代物。它还为牙科临床医生提供有关这些产品的详细准确信息。此外,基于对当前市场状况的分析以及各国趋势的比较,讨论了同种异体骨替代物的前景。在本综述中,我们重点关注在美国、日本和韩国被批准用于牙周和骨再生的同种异体骨替代物。根据美国食品药品监督管理局的数据库,自1996年以来,美国已批准87种同种异体骨移植产品。根据日本药品和医疗器械管理局的数据库,自2004年以来,日本已批准10种同种异体骨移植产品。根据韩国卫生和福利部的数据库,自1980年以来,韩国已批准36种同种异体骨移植产品。获批产品主要是羟基磷灰石、β-磷酸三钙和双相磷酸钙。各国产品的配方有所不同。新型同种异体骨产品的开发取得了显著进展。在不久的将来,具有安全性和标准化质量的同种异体骨替代物可能会成为首选,取代自体骨;它们可能会提供具有更易操作形式和适当吸收率的新型骨传导和骨诱导产品,可与生长因子和/或细胞移植一起使用。根据每种临床情况仔细选择同种异体骨移植产品对于获得可预测的结果是必要的。