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Study for maiking process of academia leading expand indications of Microscale Mist Plaque Removal Device

Research Project

Project/Area Number 20K10027
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Review Section Basic Section 57050:Prosthodontics-related
Research InstitutionTohoku University

Principal Investigator

Hihara Hiroki  東北大学, 歯学研究科, 助教 (60781292)

Co-Investigator(Kenkyū-buntansha) 佐々木 啓一  東北大学, 歯学研究科, 教授 (30178644)
鷲尾 純平  東北大学, 歯学研究科, 准教授 (20400260)
岡島 淳之介  東北大学, 流体科学研究所, 准教授 (70610161)
泉田 一賢  東北大学, 歯学研究科, 非常勤講師 (70803617)
互野 亮  東北大学, 大学病院, 助教 (80845876)
Project Period (FY) 2020-04-01 – 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 2022: ¥2,600,000 (Direct Cost: ¥2,000,000、Indirect Cost: ¥600,000)
Fiscal Year 2021: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2020: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Keywords医療機器 / デンタルバイオフィルム / 歯科補綴 / 口腔ケア / 在宅医療 / 薬事承認
Outline of Research at the Start

マイクロスケールミストを用いた新規口腔プラーク除去機器(MSM-UNIT)の創部洗浄等、安全性が必要とされる領域への適応拡大を目指し、生理食塩水等を用いてミスト化した際の挙動、プラーク付着モデルでの吹付安全性、清掃性能の確認、動物試験等非臨床評価を実施する。さらに特定臨床研究を行いヒトへの有効性、安全性を確認することで学術データのみならず薬事承認申請に必要なデータを収集する。

Outline of Final Research Achievements

This study evaluated the effectiveness and safety of the Micro Scale Mist spray UNIT (MSM-UNIT) in vitro. First, we made artificial biofilm model on simulated oral mucosa. Effectiveness was evaluated by biofilm removal rates. Biofilm removal rates was calculated from banalization images. Safety was evaluated surface roughness from SEM image. The biofilm removal rate of the MSM-UNIT was significantly higher than that of conventional device. The surface roughness of conventional device treated area was significantly larger than that of the MSM-UNIT. The MSM-UNIT could be used safely and effectively for biofilm removal on oral mucosa.

Academic Significance and Societal Importance of the Research Achievements

口腔粘膜の比較的柔らかい部分に近い弾性係数である疑似粘膜で安全性が確認されたことから、創部等の洗浄にも利用できる可能性が示唆された。また、疑似粘膜に強固に付着したデンタルバイオフィルムを水のみ除去できることが確認できたことこら、在宅や入院患者等の今までケアが難しかった患者の口腔ケアに使用できる可能性が示唆された。よって現在医療現場で問題となっている要介護高齢者の熱発・誤嚥性肺炎の抑制に寄与でき、また周術期入院患者の在院機関の短縮につなげられる可能性がある。

Report

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

    (4 results)

All 2023 2022 2021

All Journal Article (2 results) (of which Int'l Joint Research: 1 results,  Peer Reviewed: 2 results,  Open Access: 2 results) Presentation (2 results) (of which Invited: 1 results)

  • [Journal Article] Clinical Trial for Evaluating the Effectiveness and Safety of a New Dental Plaque Removal Device: Microscale Mist Unit2022

    • Author(s)
      Hihara Hiroki、Izumita Kuniyuki、Iwatsu Misato、Sato Tomoya、Tagaino Ryo、Shobara Kenta、Shinohara Yuta、Hatakeyama Takanori、Kayaba Chie、Sato Mariko、Tokue Ayako、Sugawara Tomoko、Ashino Kanamai、Ikeda Koji、Aida Jun、Sasaki Keiichi
    • Journal Title

      Antibiotics

      Volume: 11 Issue: 6 Pages: 825-825

    • DOI

      10.3390/antibiotics11060825

    • Related Report
      2022 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Effectiveness and safety of a new dental plaque removal device utilizing micro mist spray for removing oral biofilm in vitro2021

    • Author(s)
      Hihara Hiroki、Tagaino Ryo、Washio Jumpei、Laosuwan Kittipong、Wicaksono Dimas Prasetianto、Izumita Kuniyuki、Koide Rie、Takahashi Nobuhiro、Sasaki Keiichi
    • Journal Title

      BMC Oral Health

      Volume: 21 Issue: 1 Pages: 286-286

    • DOI

      10.1186/s12903-021-01647-4

    • Related Report
      2021 Research-status Report
    • Peer Reviewed / Open Access / Int'l Joint Research
  • [Presentation] アカデミアにおける歯科医療機器開発 ー審査を経験して思うことー2023

    • Author(s)
      日原 大貴
    • Organizer
      The 21th Conference on Biomechanics
    • Related Report
      2022 Annual Research Report
    • Invited
  • [Presentation] Effectiveness and safety of the Micro Scale Mist spray for removing oral biofilm in vitro2022

    • Author(s)
      Hiroki Hihara, Ryo Tagaino, Jumpei Washio, Kuniyuki Izumita, Rie Koide, Nobuhiro Takahashi and Keiichi Sasaki
    • Organizer
      Interface Summer Seminar 2022
    • Related Report
      2022 Annual Research Report

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Published: 2020-04-28   Modified: 2024-01-30  

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