Electric Toothbrush Efficacy in Preventing Dental Plaque Development: A RCT Using QLF Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- fluorescence intensity of at least 30% (ΔR30)
研究概览
简要总结
The present study will be the first to compared dental plaque quantitation between an oscillating-rotating electric toothbrush and a manual toothbrush with a new QLF technology.
详细描述
This is a randomized controlled trial of 12-weeks duration designed to assess whether a new commercially available oscillating-rotating electric toothbrush can objectively improve dental plaque parameters obtained via light induced fluorescence (QLF) technology. The study will be conducted in a dental clinic in Italy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy adult (aged 18-50 years)
- •non-smokers
- •without clinical signs of periodontitis with at least 10 natural anterior teeth in total (cuspid to cuspid and lower and upper jaw).
排除标准
- •significant oral soft tissue pathology or any type of gingival overgrowth other than plaque-induced gingivitis,
- •with fixed and removable orthodontic appliances or removable dentures,
- •with any other medical condition that, in the opinion of the principal investigator, would jeopardize the participant's safety or diminish the validity of study results
结局指标
主要结局
fluorescence intensity of at least 30% (ΔR30)
时间窗: 120 DAYS
1\) the percentage of the total tooth surface showing an increase in the fluorescence intensity of at least 30% (ΔR30) - this indicates the total area of mature dental plaque detected,
the fluorescence intensity of at least 120% (ΔR120)
时间窗: 120 DAYS
2\) the percentage of the total tooth surface showing an increase in the fluorescence intensity of at least 120% (ΔR120) - this reveals just areas of greater level of plaque thickness/maturation (i.e. calculus/tartar) within the total area of mature dental plaque detected.
次要结局
- oral hygiene (SOH) scoring, The score can be from 0, 1, .. to 5. A SOH value of 0 indicates no plaque, and 5 is the maximum and stands for maximum plaque teeth coverage an is the worst state.(120 DAYS)
研究者
Riccardo Polosa
Full Professor
Universita degli Studi di Catania