Principles for Evaluating the Efficacy and Safety of Ceramic Dental Implants in Japan

Tomoya Hara; Yuchi Sato; Hiroyuki Tanishiro; Yukimichi Tamaki; Shunsuke Baba; Eiichi Hirose; Bunsaku Yoshida; Kiyoshi Watanabe; Genki Nishikawa; Daiju Okuda; Madoka Murakami; Yuki Niwa; Masuo Kondoh

doi:10.1007/s43441-024-00713-7

Principles for Evaluating the Efficacy and Safety of Ceramic Dental Implants in Japan

Ther Innov Regul Sci. 2024 Nov 5. doi: 10.1007/s43441-024-00713-7. Online ahead of print.

Authors

Tomoya Hara^{1

2

3}, Yuchi Sato¹, Hiroyuki Tanishiro⁴, Yukimichi Tamaki⁵, Shunsuke Baba², Eiichi Hirose⁶, Bunsaku Yoshida⁷, Kiyoshi Watanabe⁷, Genki Nishikawa⁸, Daiju Okuda^{1

9}, Madoka Murakami^{8

10}, Yuki Niwa¹¹, Masuo Kondoh¹²

Affiliations

¹ Office of Medical Devices II, Pharmaceuticals and Medical Devices Agency, Tokyo, 100-0013, Japan.
² Department of Oral Implantology, Osaka Dental University, Osaka, 573-1121, Japan.
³ Healthy Policy Bureau, Ministry of Health, Labour and Welfare, Tokyo, 100-8916, Japan.
⁴ Translational Research Institute for Medical Innovation, Osaka Dental University, Osaka, 573-1121, Japan.
⁵ Department of Dental Materials Science, Division of Oral Functional Science and Rehabilitation, Asahi University School of Dentistry, Gifu, 501-0296, Japan.
⁶ Japan Association of Dental Implant Suppliers, Tokyo, 108-0014, Japan.
⁷ Japan Dental Materials Manufacturers Association, Tokyo, 111-0056, Japan.
⁸ Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, Tokyo, 100-8916, Japan.
⁹ Japan Agency for Medical Research and Development, Tokyo, 100-0004, Japan.
¹⁰ Office of Software as a Medical Device, Pharmaceuticals and Medical Devices Agency, Tokyo, 100-0013, Japan.
¹¹ Graduate School of Pharmaceutical Sciences, Osaka University, Osaka, 567-0871, Japan.
¹² Graduate School of Pharmaceutical Sciences, Osaka University, Osaka, 567-0871, Japan. [email protected].

PMID: 39500836
DOI: 10.1007/s43441-024-00713-7

Abstract

Recent progress in materials chemistry has resulted in the development of several ceramic materials that are now being used in dental implants. The advantages of ceramic materials over conventional metallic materials are that they do not induce allergic reactions in individuals with metal allergies, they do not interfere with magnetic resonance imaging, and they provide improved esthetics. In addition, some ceramic materials are tougher than metallic materials and less brittle. However, despite these advantages, few ceramic dental implant materials are currently approved for use in Japan. In FY2022, the Ministry of Health, Labour and Welfare of Japan commissioned a project called the "Project for the Development of a Guideline for the Evaluation of Ceramic Dental Implants," the goal of which was to consider how best to facilitate swift clinical development and approval of emerging ceramic dental implant materials. At a meeting of experts from professional societies, related industry organizations, and government agencies, the issues related to evaluation of the efficacy and safety of ceramic implant were discussed. Here, we summarize the outcomes of that meeting as a set of principles for the premarketing evaluation of ceramic dental implant materials in Japan.

Keywords: Ceramics; Dental Implant; Efficacy; Material; Safety.