Safety and Efficacy of the Silk'n Toothbrush (ToothWave) Home Use Device for Reduction of Gingivitis, Dental Plaque and Calculus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Gingival inflammation
研究概览
简要总结
The objective of the study is to evaluate the safety and efficacy of the home-use device Silk'n toothbrush (ToothWave) for the improvement in dental health through the reduction of plaque, gingivitis, and calculus.
详细描述
This is a single blind, prospective study aimed to evaluate the safety and efficacy of the Silk'n toothbrush in reduction of gingivitis, dental plaque and calculus.
The study includes 84 treatment sessions, twice a day, and 4 clinic visits over a period of 6 weeks.
One treatment group (Silk'n toothbrush - ToothWave) and 1 control group (an ADA approved power toothbrush (PTB)) will participate in the study.
For each patient, assessment data will be collected at baseline, 4 weeks, and at 6 weeks. The average data sets will be calculated for each group.
Treatment is defined as a timed 2 minutes of teeth brushing in a regular man-ner, twice a day (morning and evening). Brushing will be undertaken using the Silk'n toothbrush and standard fluoride toothpaste. The control group will use a regular PTB and standard fluoride toothpaste.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will not know if the toothbrush is a treatment or control brush. Outcome assessor will be blinded as well and will not know which product was dispensed to which participant.
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
- 是
入选标准
- •Adult subjects aged 18-70, that are in good health.
- •Subject must have:
- •Baseline gingivitis (MGI) score of at least 1.80, 2.
- •Dental Plaque mean score greater than 0.6 according to the RMNPI Index. 2.
- •Total Calculus deposits greater than 7 according to the Volpe-Manhold Index.
- •Have a minimum of 20 'scorable' teeth (excluding 3rd molars).
- •The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects. Subjects will sign the Informed Consent Form.
- •The subjects should be willing to comply with the study procedure and schedule, including the follow up visits.
排除标准
- •Current or history of oral cavity cancer or oropharyngeal cancer.
- •Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
- •Pregnant or nursing by subject report.
- •Any active condition in the oral cavity at the discretion of the investigator.
- •Any surgery in the oral cavity within 3 months prior to treatment, or before complete healing.
- •Subjects that do not brush regularly.
- •Any condition that might make it unsafe for the subject to participate in this study, at the discretion of the investigator.
结局指标
主要结局
Gingival inflammation
时间窗: 6 weeks
A reduction in the level of gingival inflammation according to the Modified Gingival Index (MGI).
Dental plaque
时间窗: 6 weeks
A reduction in the level of dental plaque according to Rustogi Modification of the Navy Plaque Index (RMNPI).
次要结局
- Calculus(6 weeks)