Efficacy of the Addition of a Power Interdental Device to an Electric Toothbrush on Gingival Health: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Mean change score in bleeding on probing measured at 6 sites per tooth from baseline and between groups at 4 weeks.
研究概览
简要总结
The study is designed to evaluate the clinical changes in gingival health by measuring the reduction of gingival bleeding and inflammation over 4 weeks. Additionally plaque removal will be evaluated after a single use and over 4 weeks.
详细描述
Data will be analyzed and reported as mean. The target population is approximately 70 healthy adult volunteers. There will be two groups with a total of 35 subjects per group. Subjects will be randomized using a simple random sample. A computer-generated randomization schedule will be prepared by the study statistician. Based on the randomization schedule, patients will be randomly assigned in a 1:1 ratio to receive either:
With 35 subjects per group, the study will have 90% power to detect an average reduction in the percent of sites with BOP of 25%.
The primary outcome will be the reduction in the percentage of sites with bleeding on probing (BOP) after 4 weeks.
Reduction in the percentage of sites with BOP after 2 weeks (+/- 2 days). Reduction in the MGI after 2 (+/- 2 days) and 4 weeks. Reduction in RMNPI Pre & post, 2 weeks and 4 weeks (=/- 2 days)
Data will include whole mouth, approximal, marginal, facial, and lingual analysis for all indices. Intraoral examination will be performed and any adverse events will be reported and followed up.
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
- •Be between 20 and 70 years of age
- •Be 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
- •Be in good general health and be a non-smoker
- •Have 50% bleeding on probing sites (moderate gingivitis)
- •Have no probing depths greater than 4 mm
- •Have 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
- •Have probing depth greater than 4 mm
- •Have a systemic disease (ex. Diabetes, autoimmune disease)
- •Have advanced periodontitis
- •Taking medication that can influence gingival health (ex. Dilantin, Procardia (calcium channel blockers), Cyclosporine, anticoagulants)
- •Have orthodontic appliances or removable partial dentures
- •Pregnant at time of study
- •Use of antibiotics within 6 months of study
研究组 & 干预措施
Electric toothbrush and power interdental device
Electric toothbrush and power interdental device
干预措施: Electric toothbrush (Device)
Electric toothbrush
Electric toothbrush
干预措施: Control (Device)
结局指标
主要结局
Mean change score in bleeding on probing measured at 6 sites per tooth from baseline and between groups at 4 weeks.
时间窗: 4 weeks
Bleeding on Probing
Mean change score in gingival inflammation from baseline and between groups measured by Modified Gingival Index at 4 weeks
时间窗: 4 weeks
Modified Gingival Index
次要结局
- Mean change score in dental plaque from baseline and between groups measured by Rustogi Modification of the Navy Plaque Index at 4 weeks.(pre & post, 4 weeks)