NCT03049761已完成不适用
Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different Pressure Settings
All Sum Research Center Ltd.0 个研究点目标入组 105 人开始时间: 2017年1月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 主要终点
- Clinical Attachment Levels
研究概览
简要总结
Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different Pressure Settings
详细描述
This study is designed to add to the safety data by measuring, Oral Soft tissue, Clinical Attachment Levels and Probing Pocket Depths on different pressure settings at different time points over a 6 week period. Data will be collected at Baseline, 2 week, 4 week and 6 week time frames.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Written consent prior to participation
- •Good general health and non smoker
- •Have scorable Ramfjord's teeth
排除标准
- •Probing depth >4mm on Ramfjord's teeth
- •Moderate to severe gingivitis
- •Advanced periodontitis
- •Medications that impact soft tissue.
研究组 & 干预措施
Water Flosser
Active Comparator
Power interdental Cleaning Device
干预措施: Water Flosser (Device)
String floss
Active Comparator
Manual interdental cleaning device
干预措施: String Floss (Device)
Manual Toothbrush
Active Comparator
ADA standard manual toothbrush
干预措施: Manual Toothbrush (Device)
结局指标
主要结局
Clinical Attachment Levels
时间窗: 6 weeks
Measurement from the junction Epithelium to the cemento enamel junction
次要结局
- Probing pocket depth(6 weeks)
研究者
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