Clinical trial of a new oral plaque removal device using the micro-scale mist

Phase 1

• Conditions: Oral hygiene failure Aspiration pneumonia

• Registration Number: JPRN-UMIN000026097
• Lead Sponsor: Tohoku University Graduate School of Dentistry

Brief Summary

Plaque removal test on the tooth surface and safety assessment test on the palate and gingiva were performed on five healthy dentated chin. Regarding the effectiveness of plaque removal, reduction of plaque on the tooth surface was confirmed, but in some cases it could not be said that it is clinically adequate effect, and it is considered that investigation of injection distance and injection time is necessary from now on It was. For safety assessment, it is considered that safety can be secured under the conditions of use in this clinical trial without changing VAS or inflammatory findings in the palate, gums, gingiva and examination of the evaluation of the effectiveness of plaque removal in the palate from now on is necessary. As a future task, confirmation of effectiveness to molar parts and establishment of evaluation index at that time are necessary. No adverse events were observed in the use of this instrument.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-16
• Study Completion: 2017-03-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

(1) a person who has a significant malocclusions and periodontal disease (2) Persons who have periodontal diseases (periodontitis, gingivitis, etc.) of BOP (+) with periodontal pocket of 5 mm or more in both maxillary middle incisors (3) Persons with dental caries or medical history on the maxillary both-side central incisors (4) a person who has oral mucosal disease (5) those with vomiting reflex (6) Other, who one and principal investigator with systemic disease or research team members has judged it difficult to participate in test

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(1) cleaning rate after mist injection into the upper jaw on both sides central incisor (comparison of before and after treatment) (2) assessment of pain immediately after and one day after the mist injection into the hard palate portion and the gingibal. (3) assessment of inflammation immediately after and one day after the mist injection into the hard palate portion and the gingibal.

Secondary Outcome Measures

Name	Time	Method
(1) adverse events and the failure