NCT02836223已完成不适用
Evaluation of the Addition of an Interdental Cleaning Device to Manual Brushing on Gingival Health
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Reduction of gingival bleeding
研究概览
简要总结
This study evaluates the addition of an interdental cleaning device paired with a manual toothbrush compared to using a manual toothbrush only. Plaque removal, reduction of gingival bleeding and reduction of gingival inflammation.
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 (Investigator)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 25 and 70 years of age
- •Able to provide written informed consent prior to participation
- •Agree to not participate in any other oral/dental products clinical study for the study duration
- •Good general health and be a non-smoker
- •A minimum of 50% bleeding on probing sites
- •A minimum pre-brushing plaque score of 0.6
- •A minimum of 1.75 gingivitis score Have no probing depths greater than 5 mm
- •A minimum of 20 teeth (not including 3rd molars)
- •No partial dentures, orthodontic brackets, wires or other appliances
- •Agree to refrain from the use of any non-study dental device or oral care product for the study duration
- •Agree to return for the scheduled visits and follow study procedures
- •Agree to delay dental prophylaxis until study completion
- •Have a minimum pre-brushing plaque score of 0.6
- •Have a minimum of 1.75 gingivitis score
排除标准
- •Probing depth greater than 5 mm
- •Systemic disease (ex. Diabetes, autoimmune disease)
- •Advanced periodontitis
- •Taking medication that can influence gingival health such as seizure meds, calcium channel blockers, Cyclosporine, anticoagulants
- •Orthodontic appliances or removable partial dentures
- •Pregnant at time of study
- •Use of antibiotics within 6 months of study
结局指标
主要结局
Reduction of gingival bleeding
时间窗: 4 weeks
次要结局
- Reduction of gingival inflammation(4 weeks)
- Reduction in dental plaque(4 weeks)
研究者
研究点 (2)
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