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

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

doi:https://doi.org/10.1007/s43441-024-00713-7

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

Hara, Tomoya; Sato, Yuchi; Tanishiro, Hiroyuki et al.

Therapeutic Innovation and Regulatory Science, 2024, 59(1), 3-8

アクセス数:1,152件（2025-09-29 11:30 集計）

固定URL: https://hdl.handle.net/11094/98810

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タイトル	Principles for Evaluating the Efficacy and Safety of Ceramic Dental Implants in Japan
著者	著者名 Hara, Tomoya
	著者名 Sato, Yuchi
	著者名 Tanishiro, Hiroyuki
	NRID 1000080197566 1000080197566 著者名 Tamaki, Yukimichi
	NRID 1000040275227 1000040275227 著者名 Baba, Shunsuke
	著者名 Hirose, Eiichi
	著者名 Yoshida, Bunsaku
	著者名 Watanabe, Kiyoshi
	著者名 Nishikawa, Genki
	著者名 Okuda, Daiju
	著者名 Murakami, Madoka
	NRID 1000020756077 1000020756077 researchmap permalink yuki_niwa yuki_niwa 著者名 Niwa, Yuki
	NRID 1000050309697 1000050309697 researchmap permalink read0083480 read0083480 Scopus Author ID 26643156500 26643156500 著者名 Kondoh, Masuo
キーワード等	Ceramics
	Dental Implant
	Efficacy
	Material
	Safety
内容	The version of record of this article, first published in Therapeutic Innovation and Regulatory Science, is available online at Publisher’s website: https://doi.org/10.1007/s43441-024-00713-7.
抄録	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.
出版者	Springer Science and Business Media Deutschland GmbH
収録物名	Therapeutic Innovation and Regulatory Science
巻(号)	59(1)
ページ	3-8
刊行年月	2024-11-05
言語	英語
ハンドルURL	https://hdl.handle.net/11094/98810
PISSN	21684790
eISSN	21684804
関連情報 (isIdenticalTo)	DOI (出版社版) https://doi.org/10.1007/s43441-024-00713-7
アクセス権	open access
権利情報	This article is licensed under a Creative Commons Attribution 4.0 International License.
出版タイプ	Version of Record
カテゴリ	学術雑誌論文 Journal Article

資源タイプ	学術雑誌論文
ローカル資源タイプ	学術雑誌論文
DCTERMS.bibliographicCitation	Therapeutic Innovation and Regulatory Science. 2024, 59(1), p. 3-8
DC.title	Principles for Evaluating the Efficacy and Safety of Ceramic Dental Implants in Japan
DC.creator	Hara, Tomoya
	Sato, Yuchi
	Tanishiro, Hiroyuki
	Tamaki, Yukimichi
	Baba, Shunsuke
	Hirose, Eiichi
	Yoshida, Bunsaku
	Watanabe, Kiyoshi
	Nishikawa, Genki
	Okuda, Daiju
	Murakami, Madoka
	Niwa, Yuki
	Kondoh, Masuo
DC.publisher	Springer Science and Business Media Deutschland GmbH
DC.language' scheme='DCTERMS.RFC1766	英語
DCTERMS.issued' scheme='DCTERMS.W3CDTF	2024-11-05
DC.identifier	https://doi.org/10.1007/s43441-024-00713-7
DC.subject	Ceramics
	Dental Implant
	Efficacy
	Material
	Safety
DC.description	The version of record of this article, first published in Therapeutic Innovation and Regulatory Science, is available online at Publisher’s website: https://doi.org/10.1007/s43441-024-00713-7.
DCTERMS.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.
DC.rights	This article is licensed under a Creative Commons Attribution 4.0 International License.
DC.format	98810
citation_title	Principles for Evaluating the Efficacy and Safety of Ceramic Dental Implants in Japan
citation_author	Hara, Tomoya
	Sato, Yuchi
	Tanishiro, Hiroyuki
	Tamaki, Yukimichi
	Baba, Shunsuke
	Hirose, Eiichi
	Yoshida, Bunsaku
	Watanabe, Kiyoshi
	Nishikawa, Genki
	Okuda, Daiju
	Murakami, Madoka
	Niwa, Yuki
	Kondoh, Masuo
citation_publisher	Springer Science and Business Media Deutschland GmbH
citation_language	英語
citation_date	2024-11-05
citation_journal_title	Therapeutic Innovation and Regulatory Science
citation_volume	59
citation_issue	1
citation_firstpage	3
citation_lastpage	8
citation_doi	https://doi.org/10.1007/s43441-024-00713-7
citation_public_url	https://hdl.handle.net/11094/98810

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

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