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A multicenter prospective study for elucidating the risk factors and establishing prevention methods of medical-related osteonecrosis of the jaws (MRONJ) .

Research Project

Project/Area Number 19K10431
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Review Section Basic Section 57080:Social dentistry-related
Research InstitutionKansai Medical University

Principal Investigator

KOJIMA Yuka  関西医科大学, 医学部, 教授 (70720655)

Co-Investigator(Kenkyū-buntansha) 岩井 大  関西医科大学, 医学部, 教授 (10232638)
五月女 さき子  長崎大学, 医歯薬学総合研究科(歯学系), 准教授 (20325799)
長谷川 巧実  神戸大学, 医学部附属病院, 助教 (50546497)
梅田 正博  長崎大学, 医歯薬学総合研究科(歯学系), 教授 (60301280)
船原 まどか  九州歯科大学, 歯学部, 講師 (60796811)
Project Period (FY) 2019-04-01 – 2023-03-31
Project Status Completed (Fiscal Year 2022)
Budget Amount *help
¥4,290,000 (Direct Cost: ¥3,300,000、Indirect Cost: ¥990,000)
Fiscal Year 2021: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2020: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2019: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Keywords薬剤関連顎骨壊死 / 発症予防 / 抜歯 / 口腔衛生管理 / 骨吸収抑制薬 / 休薬 / 破骨細胞 / 局所感染 / 多施設共同研究 / 口腔衛生状態 / 骨抑制吸収薬 / 休薬期間 / 骨代謝 / 多施設共同前向き研究
Outline of Research at the Start

今回、(一社)日本口腔ケア学会の全面的な協力を得て、30施設の参加により大規模な多施設共同前向き観察研究を実施し、MRONJの発症予防法について明らかにする。さらに3施設で抜歯を行った患者において、抜歯窩内の感染の有無をPCRで、削除した歯槽骨内の骨代謝マーカーをELISAで、骨代謝関連遺伝子をリアルタイムRT-PCRで解析し、局所感染の有無とMRONJ発症、骨吸収抑制薬休薬期間と局所骨代謝との関連について検討し、MRONJの発症予防法を確立する。

Outline of Final Research Achievements

Surgical intervention to the bone, such as tooth extraction, has been suggested as a risk factor for the development of meducation-related osteonecrosis of the jaw (MRONJ). However, some investigators reported that MRONJ is caused by a local infection in the extracted tooth rather than the extracted tooth itself. The purpose of this study was to clarify whether surgical invasion of the bone or local infection is more important for the risk of developing MRONJ. A multicenter clinical study by the Japanese Society of Oral Care revealed that the subsequent incidence of MRONJ in patients treated with high-dose antiresorptive drugs was significantly higher if the tooth with the source of infection was preserved compared to tooth extraction. Patient registration has been completed and follow-up is currently underway to determine whether the risk of onset can be reduced by maintaining good oral hygiene.

Academic Significance and Societal Importance of the Research Achievements

薬剤関連顎骨壊死(MRONJ)の発症予防法は確立していない。これまで侵襲的歯科治療が主要な発症リスク因子と考えられてきた。しかし感染源になる歯を温存すると同部位よりMRONJが発症することも経験される。本研究では高用量骨吸収抑制薬(ARA)が投与されている患者において、感染源になる歯を温存する場合、抜歯した場合と比べてMRONJ発症率は有意に高くなることを明らかにした。さらにMRONJが発症した際にはARAの休薬は行わずに直ちに手術を行ったほうがよいこと、ARAの数か月程度の休薬は破骨細胞抑制を回復させないことも示した。現在口腔衛生管理により発症率が低下するかどうか、前向き研究を実施中である。

Report

(5 results)
  • 2022 Annual Research Report   Final Research Report ( PDF )
  • 2021 Research-status Report
  • 2020 Research-status Report
  • 2019 Research-status Report
  • Research Products

    (2 results)

All 2022

All Journal Article (2 results) (of which Peer Reviewed: 2 results,  Open Access: 1 results)

  • [Journal Article] Relationship between Drug Holidays of Antiresorptive Agents and Surgical Outcomes in Cancer Patients with Medication-Related Osteonecrosis of the Jaw2022

    • Author(s)
      Otsuru Mitsunobu、Soutome Sakiko、Omori Keisuke、Suyama Koki、Morishita Kota、Hayashida Saki、Murata Maho、Takagi Yukinori、Sasaki Miho、Sumi Misa、Kojima Yuka、Sawada Shunsuke、Sakamoto Yuki、Umeda Masahiro
    • Journal Title

      International Journal of Environmental Research and Public Health

      Volume: 19 Issue: 8 Pages: 4624-4624

    • DOI

      10.3390/ijerph19084624

    • Related Report
      2022 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Factors Exacerbating Clinical Symptoms and CT Findings in Patients with Medication-Related Osteonecrosis of the Jaw Receiving Conservative Therapy: A Multicenter Retrospective Study of 53 Cases.2022

    • Author(s)
      Kojima Y, Soutome S, Otsuru M, Hayashida S, Sakamoto Y, Sawada S, Umeda M
    • Journal Title

      Int J Environ Res Public Health.

      Volume: Jun 26 Issue: 13 Pages: 7854-7854

    • DOI

      10.3390/ijerph19137854

    • Related Report
      2022 Annual Research Report
    • Peer Reviewed

URL: 

Published: 2019-04-18   Modified: 2024-01-30  

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