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

Number of Access:1,121（2025-08-14 02:42 Counts）

Identifier to cite or link to this item: https://hdl.handle.net/11094/98810

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Title	Principles for Evaluating the Efficacy and Safety of Ceramic Dental Implants in Japan
Creator	CreatorName Hara, Tomoya
	CreatorName Sato, Yuchi
	CreatorName Tanishiro, Hiroyuki
	NRID 1000080197566 1000080197566 CreatorName Tamaki, Yukimichi
	NRID 1000040275227 1000040275227 CreatorName Baba, Shunsuke
	CreatorName Hirose, Eiichi
	CreatorName Yoshida, Bunsaku
	CreatorName Watanabe, Kiyoshi
	CreatorName Nishikawa, Genki
	CreatorName Okuda, Daiju
	CreatorName Murakami, Madoka
	NRID 1000020756077 1000020756077 researchmap permalink yuki_niwa yuki_niwa CreatorName Niwa, Yuki
	NRID 1000050309697 1000050309697 researchmap permalink read0083480 read0083480 Scopus Author ID 26643156500 26643156500 CreatorName Kondoh, Masuo
Subject	Ceramics
	Dental Implant
	Efficacy
	Material
	Safety
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.
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.
Publisher	Springer Science and Business Media Deutschland GmbH
Source Title	Therapeutic Innovation and Regulatory Science
Volume (Issue)	59(1)
Page	3-8
Date of Issued	2024-11-05
Language	English
Handle URL	https://hdl.handle.net/11094/98810
PISSN	21684790
eISSN	21684804
Relation.isIdenticalTo	DOI (Publisher Version) https://doi.org/10.1007/s43441-024-00713-7
Access Rights	open access
CopyRight	This article is licensed under a Creative Commons Attribution 4.0 International License.
oaire:version	Version of Record
Category	学術雑誌論文 Journal Article

Resource Type	journal article
Local Type	Journal Article
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	English
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	English
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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