Clinical trial for evaluating the effectiveness and safety of a new dental plaque removal device: Microscale mist unit

Abstract Objectives: The purpose of this study is to evaluate the effectiveness and safety of a microscale mist unit (MSM-UNIT), a newly developed dental plaque removal device that sprays high-speed fine water droplets, with regard to removal of dental plaque adhering to the oral mucosa (tongue, palate) and tooth surface.Materials and Methods: Fifteen patients who had difficulty self-managing sufficient oral care were included in this study. Effectiveness was evaluated in at least five patients per tongue, palate mucosa, and tooth surface, and the safety evaluation was conducted at all three sites for all patients. Effectiveness was evaluated using the rate of degree of dental plaque removal, and safety was evaluated using a numerical rating scale (NRS) for pain and symptoms of inflammation. An operator who performs treatment and evaluator who evaluates effectiveness and safety were designated. In addition, as a third party, an image judgment committee judged the effectiveness.Results: Although the evaluation for the tongue varied between the evaluator and the image judgment committee, after applying the MSM-UNIT, the rate for all degrees of plaque removal increased in all regions. In addition, low pain NRS and symptoms of inflammation were observed and within acceptable range.Conclusion: The MSM-UNIT can be used effectively and safely for removing oral plaque not only from teeth but also from the oral mucosa.Clinical Relevance: The MSM-UNIT may be used in whole oral care including for the removal of oral membranous substances in nursing and hospitalized patients.Trial registration: This study was registered on the Japan Primary Registries Network (JPRN) of University Hospital Medical Information Network Center (UMIN-CTR). The registration number was JPRN-UMIN000035950 (date of first registration: 01/03/2019).