Safety and Efficacy of the ToothWave (Model H7001) Powered Toothbrush Home Use Device for Extrinsic Stain Reduction (Texas)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Extrinsic Stains
研究概览
简要总结
This study is a single blind, prospective study aimed to evaluate the safety and efficacy of the Silk'n ToothWave Powered Toothbrush for stains reduction and improvement of teeth shade.
详细描述
The study includes a total of 84 treatment sessions, twice a day, and 4 clinic visits over a period of 6 weeks.
One treatment group (Silk'n powered toothbrush - ToothWave) and 1 control group (an ADA approved powered toothbrush (PTB)) will participate in the study.
For each patient, efficacy assessment data will be collected at baseline, 4 weeks, and at 6 weeks. The average stain data will be calculated for each group.
Treatment is defined as a timed, 2 minute brushing of the teeth according to the manufacturer's instructions, twice daily (morning and evening). Brushing will be undertaken using the Silk'n toothbrush and standard fluoride toothpaste. The control group will use an ADA accepted 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
- Single (Outcomes Assessor)
盲法说明
The Outcomes Assessors will not be exposed to the type of brush the subject is using or to the group they are assigned to (treatment or control).
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.
- •Subjects should have notable extrinsic dental stains on the 6 maxillary labial front teeth, or on the 6 mandibular front teeth (lingual or labial), with a total extrinsic tooth stain score ≥14 according to the LSI.
- •Subject must have at least 2 natural anterior teeth, each having a mean Lobene composite score of ≥ 1.5 as assessed by the Investigator.
- •Subject front teeth shade should be 9 or darker (meaning shade score should be between 9 and 29), as assessed by the Vita bleachedguide 3D-Master or the Vita EasyShade device.
- •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, and will refrain from using any other teeth whitening technologies during this period.
- •The subject did not perform any procedure for teeth whitening (either at home or in clinic) at least 3 years prior to participating in the study.
排除标准
- •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 treated area 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 the study, at the discretion of the investigator.
结局指标
主要结局
Extrinsic Stains
时间窗: 6 weeks
Extrinsic Stains will be evaluated using the validated Lobene Stain Index (LSI) Stain Intensity score range is between 0 and 3, where: 0 = no stain 1. = light stain 2. = moderate stain 3. = heavy stain The mean stain intensity will be calculated for both the gingival and body regions of the incisor teeth for each subject. Stain Area score rage is between 0 and 3, where: 0 = no stain 1. = stain covering up to one third of region 2. = stain covering up to two thirds of region 3. = stain covering more than two thirds of region The mean stain area will be calculated for both the gingival and body regions of the incisor teeth for each subject.
次要结局
- Tooth color assessment(6 weeks)