Clinical trial of a new oral plaque removal device using the micro-scale mist - Oral plaque removal test by the micro-scale mist
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(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