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
- 1
- 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
研究组 & 干预措施
A Digital
oscillating-rotating electric toothbrush group
干预措施: oscillating toothbrush (Behavioral)
B Manual
manual toothbrush group
干预措施: standard manual toothbrush (Behavioral)
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