Evaluating the Effect of a Novel Interproximal Cleaning Device on Oral Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Residual Protein Concentration
研究概览
简要总结
This is a study to evaluate the safety and the efficacy of tooth and interproximal cleaning modalities on oral health.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are in good/excellent health;
- •are 18 - 70 years old;
- •have a minimum of 20 natural teeth (excluding 3rd molars);
- •have sufficient test sites;
- •have ≥ 20 bleeding sites;
- •are willing to participate and available for participation.
排除标准
- •have systemic diseases such as Down's syndrome, or known AIDS/HIV;
- •have insulin dependant Diabetes;
- •are pregnant or nursing by subject report;
- •have a cardiac pacemaker
- •are undergoing or require extensive dental or orthodontic treatment;
- •require antibiotic treatment for dental appointments;
- •have heavy deposits of calculus;
- •have severe gingivitis or periodontitis;
- •have extensive crown or bridge work and/or rampant decay;
- •currently use bleaching trays;
- •have any oral or extraoral piercing on lips or in mouth;
- •have a professional prophylaxis within 4 weeks of study;
- •participation in a prior study ≤ 20 days;
- •employed by a oral healthcare products company or research institution.
研究组 & 干预措施
Manual Toothbrush 1
Manual Toothbrush used for 1 minute twice a day
干预措施: Manual Toothbrush (Device)
Manual Toothbrush 2
Manual Toothbrush used for 2 minutes twice a day
干预措施: Manual Toothbrush (Device)
Manual Toothbrush + Interproximal Cleaning 1
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day
干预措施: Manual Toothbrush (Device)
Manual Toothbrush + Interproximal Cleaning 1
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day
干预措施: Interproximal Cleaning Device (Device)
Manual Toothbrush + Interproximal Cleaning 2
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day
干预措施: Manual Toothbrush (Device)
Manual Toothbrush + Interproximal Cleaning 2
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day
干预措施: Interproximal Cleaning Device (Device)
结局指标
主要结局
Residual Protein Concentration
时间窗: 14 days
Residual protein concentration of interproximal plaque samples
次要结局
- Residual Protein Concentration(28 days)
- Modified Gingival Index(28 days)
- Gingival Bleeding Index(28 days)
- Modified Gingival Index(14 days)
- Gingival Bleeding Index(14 days)