Abstract
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.
Highlights
Dental bone graft materials have been commonly used with growth factors and/or barrier membranes in situations such as periodontal regeneration therapies and guided bone regeneration procedures before implant placements [1,2]
Thorough research was conducted by the authors using the terms “alloplastic”, “synthetic”, “bone graft”, and “substitute” in multiple databases to identify alloplastic bone substitute products approved by United States Food and Drug Administration (FDA), Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and Korean Ministry of Health and Welfare (MOHW) for periodontal and oral implant applications, using an approach described in previous reports [29,30,31,32]
87 alloplastic bone graft products were approved by the FDA from 1996 to December 2020: 15 hydroxyapatite (HA), 21 β-tricalcium phosphate (β-TCP), 18 biphasic calcium phosphate (BCP), 5 calcium sulfate (CS), 5 calcium phosphate (CP: detailed composition was not confirmed), 11 bioglass (BG), and 4 others
Summary
Dental bone graft materials have been commonly used with growth factors and/or barrier membranes in situations such as periodontal regeneration therapies and guided bone regeneration procedures before implant placements [1,2]. In recent years, these materials have been applied to bone defects caused by peri-implantitis [3,4]. Autologous bone is considered the gold standard because it is the only bone graft that has the following three properties: osteogenesis, osteoinduction, and osteoconduction [8,9,10]. Osteoconduction is a mechanical structure property comprising biocompatibility for the migration of osteogenic cells [11,12]
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