Plaque Removal Efficacy of Four Dentifrices Following a Single Brushing
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Mean change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all surfaces of the whole mouth measured.
研究概览
简要总结
The purpose of this study is to evaluate and compare plaque removal efficacy of four dentifrices following a single timed tooth brushing. Prior to each evaluation visit of the four-way cross-over study, subjects will abstain from all oral hygiene for 24 hours. At each evaluation visit, subjects will be given a pre-brushing plaque evaluation, followed by a 1-minute supervised brushing and a post-brushing plaque evaluation.
详细描述
This study is a randomized, single-brushing, examiner-blinded, 4-cell cross-over design that enrolled approximately 70 subjects to ensure that at least 60 subjects to complete the study. This 4-week cross-over study will evaluate plaque removal following a single brushing with the assigned dentifrices. Qualified subjects will have sufficient plaque (Lobene-Soparkar Modification of Turesky Plaque Index). Subjects will be given a pre-brushing plaque evaluation, followed by a 1-minute supervised brushing and a post-brushing plaque evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 69 years
排除标准
- •Have any known allergies or sensitivities to marketed dentifrice or oral hygiene products.
- •Have fixed or removable orthodontic appliances, peri/oral piercings, or removable partial dentures.
- •Evidence of poor oral hygiene, rampant dental caries, presence of extrinsic stain or calculus deposits that may interfere with plaque assessments.
研究组 & 干预措施
Toothpaste 1 with Stannous Fluoride
Toothpaste with Stannous Fluoride
干预措施: Dentifrices (Drug)
Toothpaste 1 with Sodium Fluoride and sodium bicarbonate
Toothpaste with Sodium Fluoride and sodium bicarbonate
干预措施: Dentifrices (Drug)
Toothpaste 2 with Stannous Fluoride
Toothpaste with Stannous Fluoride
干预措施: Dentifrices (Drug)
Toothpaste 2 with sodium Fluoride and sodium bicarbonate
Toothpaste with sodium Fluoride and sodium bicarbonate
干预措施: Dentifrices (Drug)
结局指标
主要结局
Mean change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all surfaces of the whole mouth measured.
时间窗: up to 4 weeks
plaque evaluation
次要结局
未报告次要终点