Efficacy of an Automatic Toothbrush With Nylon Bristles in Removing Dental Plaque: a Randomized Cross-over Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in full mouth plaque score
研究概览
简要总结
The objective of this study is to compare the efficacy in terms of bacterial plaque removal, in a single use, of a new Y-shaped automatic electric toothbrush with nylon bristles, compared with the electric toothbrush of similar shape but with silicone bristles, with the manual toothbrush, and with a negative control (no brushing) in a group of volunteer students.
Primary endpoint: difference in "full mouth plaque score" between before and after brushing.
Secondary endpoint: sensation of "clean mouth" assessed on VAS scale from 0 to 10 where 0 indicates no sensation of clean mouth and 10 maximum sensation of clean mouth.
Single-center, randomized, controlled, superiority, cross-over, examiner-blinded study with 5 treatments (Y-shaped electric toothbrush with nylon bristles, similarly shaped electric toothbrush with silicone bristles, manual brushing for 45 seconds, manual brushing for 2 minutes, no brushing), carried out in a single session and spaced one week apart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Absence of fixed orthodontic appliances
- •Presence of at least 20 teeth
- •Full mouth plaque score greater than 40%
- •Having provided signed and dated informed consent.
排除标准
- •Subjects with manual inability to perform normal oral hygiene maneuvers
- •Subjects allergic to silicone or nylon.
研究组 & 干预措施
Manual toothbrush used for 45 seconds
干预措施: Manual toothbrush used for 45 seconds (Other)
No brushing
Automatic toothbrush with nylon bristles
干预措施: Automatic toothbrush with nylon bristle (Other)
Automatic toothbrush with silicone bristles
干预措施: Automatic toothbrush with silicone bristle (Other)
Manual toothbrush used for 2 minutes
干预措施: Manual toothbrush used for 2 minutes (Other)
结局指标
主要结局
Change in full mouth plaque score
时间窗: 5 minutes
Difference in full mouth plaque score between before and after brushing
次要结局
- Perception of "clean mouth"(5 minutes)
研究者
Lorenzo Franchi
Professor
University of Florence