A Randomized, Parallel-design Study to Evaluate the Effects of Home Use of the Sonicare Powered Toothbrush and a Manual Toothbrush on Subjects With Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 346
- 试验地点
- 1
- 主要终点
- Change in symptoms of inflammation of the periodontium, as measured by Bleeding on Probing.
研究概览
简要总结
The effect of use of powered toothbrushing in patients exhibiting periodontal inflammation has been observed repeatedly in clinical studies conducted over a 20+ year period. Whether these subjects also had periodontitis, or not, was not a collected data metric as it was outside the scope of the Investigation. This study, therefore, will specifically include and document that a subject exhibits periodontitis upon study entry, and measure the ensuing response following professional treatment of scaling and root planing, followed by home use of the assigned study products (powered or manual toothbrushing).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 18-75 years
- •Exhibiting Stage I or II periodontitis
- •Minimum of 20 'scorable' teeth (excluding 3rd molars)
- •Regular manual toothbrush user
- •Have a minimum average plaque score of > 1.8 per Modified Plaque Index scoring with 3-6 hours plaque accumulation
- •Agree to desist use of interproximal cleaning aids and other prohibited devices or medicaments during the study period
- •Be a non-smoker (> 10 years), or never smoker
排除标准
- •Have a cardiac pacemaker or implanted cardiac defibrillator
- •Have uncontrolled Insulin-Dependent Diabetes Have current use of antibiotic medications or use within 4 weeks of enrollment
- •Have current use of prescription-dose anti-inflammatory medications or anticoagulants Have excessive gingival recession, per Investigator/Examiner discretion
- •Have heavy deposits of calculus, either supragingival and/or subgingival, per Investigator/Examiner discretion
- •Have had a professional prophylaxis within 4 weeks of the study
- •Prior chemotherapy, immunotherapy or radiation therapy within last 10 years
研究组 & 干预措施
ADA (American Dental Association) approved Manual Toothbrush
干预措施: ADA approved Manual Toothbrush (Device)
Marketed Power Toothbrush
干预措施: Marketed Power Toothbrush (Device)
结局指标
主要结局
Change in symptoms of inflammation of the periodontium, as measured by Bleeding on Probing.
时间窗: 6 months
次要结局
- Change in clinical attachment level(6 months)
- Change in supragingival plaque, as measured by Modified Plaque Index(6 months)
- Change in periodontitis, as measured by probing pocket depth(6 months)