Evidence map›Paper›PMID 39500836›Full record

ArticleTherapeutic innovation & regulatory science2025

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 and 3 more

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Article in Therapeutic innovation & regulatory science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Tomoya HaraOffice of Medical Devices II, Pharmaceuticals and Medical Devices Agency, Tokyo, 100-0013, Japan.
Yuchi SatoOffice of Medical Devices II, Pharmaceuticals and Medical Devices Agency, Tokyo, 100-0013, Japan.
Hiroyuki TanishiroTranslational Research Institute for Medical Innovation, Osaka Dental University, Osaka, 573-1121, Japan.
Yukimichi TamakiDepartment of Dental Materials Science, Division of Oral Functional Science and Rehabilitation, Asahi University School of Dentistry, Gifu, 501-0296, Japan.
Shunsuke BabaDepartment of Oral Implantology, Osaka Dental University, Osaka, 573-1121, Japan.
Eiichi HiroseJapan Association of Dental Implant Suppliers, Tokyo, 108-0014, Japan.
Bunsaku YoshidaJapan Dental Materials Manufacturers Association, Tokyo, 111-0056, Japan.
Kiyoshi WatanabeJapan Dental Materials Manufacturers Association, Tokyo, 111-0056, Japan.
Genki NishikawaPharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, Tokyo, 100-8916, Japan.
Daiju OkudaOffice of Medical Devices II, Pharmaceuticals and Medical Devices Agency, Tokyo, 100-0013, Japan.
Madoka MurakamiPharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, Tokyo, 100-8916, Japan.
Yuki NiwaGraduate School of Pharmaceutical Sciences, Osaka University, Osaka, 567-0871, Japan.
Masuo KondohGraduate School of Pharmaceutical Sciences, Osaka University, Osaka, 567-0871, Japan. masuo@phs.osaka-u.ac.jp.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

CeramicsDental ImplantsHumansJapanDental ImplantsCeramicsDental ImplantEfficacyMaterialSafety

Identifiers

PMID39500836
PMCPMC11706920

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