Clinical Trial for Evaluating the Effectiveness and Safety of a New Dental Plaque Removal Device: Microscale Mist Unit

Hiroki Hihara, Kuniyuki Izumita, Misato Iwatsu, Tomoya Sato, Ryo Tagaino, Kenta Shobara, Yuta Shinohara, Takanori Hatakeyama, Chie Kayaba, Mariko Sato, Ayako Tokue, Tomoko Sugawara, Kanamai Ashino, Koji Ikeda, Jun Aida, Keiichi Sasaki

Research output: Contribution to journalArticlepeer-review


This study evaluates the effectiveness and safety of a microscale mist unit (MSM-UNIT) that sprays high-speed fine water droplets to remove dental plaque adhering to the oral mucosa (tongue and palate) and tooth surface. Fifteen patients who had difficulty self-managing sufficient oral care were included in this study. Effectiveness was evaluated for at least five patients’ tongues, palate mucosas, and tooth surfaces, and safety evaluation was conducted at all three sites for all patients. Effectiveness was evaluated using the rate of degree of dental plaque removal. Safety was evaluated using a numerical rating scale (NRS) for pain and symptoms of inflammation. An operator who performed treatment and an evaluator who evaluated effectiveness and safety were designated. In addition, an image judgment committee judged effectiveness. Although evaluation of the tongue varied between the evaluators and the image judgment committee, the rates of degree for all plaque removal increased in all regions. In addition, low pain NRS results and minimal symptoms of inflammation were observed and within an acceptable range. The MSM-UNIT can be used effectively and safely for removing oral plaque not only from teeth, but also from the oral mucosa.

Original languageEnglish
Article number825
Issue number6
Publication statusPublished - 2022 Jun


  • clinical trial
  • dental biofilm
  • medical device
  • oral care
  • oral mucosa

ASJC Scopus subject areas

  • Microbiology
  • Biochemistry
  • Pharmacology, Toxicology and Pharmaceutics(all)
  • Microbiology (medical)
  • Infectious Diseases
  • Pharmacology (medical)


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