Effectiveness of Toothpaste Tablets on Plaque, Gingival Health and Caries Experiences: A 6-week Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Gingival Index Score at Baseline
研究概览
简要总结
Objectives: To evaluate the effectiveness of toothpaste tablets when compared to conventional dentifrices in removing plaque.
Methods: 50 participants are randomized into two groups: Denttabs toothpaste tablets (T) and Colgate's Cavity Protection toothpaste (P). Both groups utilize their assigned dentifrice for 6 weeks. A pre and post-assessment measures the Gingival Index (GI) and Plaque Index (PI) and Decayed, Missing and Filled Teeth (DMFT). A questionnaire on the use of the product is distributed at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects are 18 years or older;
- •Subjects who will comply with study protocol;
- •Subjects who can read and understand the consent form;
- •Subjects available during the study period;
- •Subjects have more than 20 teeth.
排除标准
- •1. Subjects under the age of 18.
研究组 & 干预措施
Toothpaste Tablet
Subjects are instructed to use one toothpaste tablet at each brushing. Brushing is recommended twice daily for two minutes.
干预措施: Toothpaste Tablet (Drug)
Conventional Toothpaste
Subjects are instructed to use the toothpaste at each brushing. Brushing is recommended twice daily for two minutes.
干预措施: Conventional Toothpaste (Drug)
结局指标
主要结局
Gingival Index Score at Baseline
时间窗: Change between baseline at visit 1 and visit 2, six weeks post baseline
The severity of gingival inflammation is measured visually using the Loe-Silness Gingival Index. Gingival index can range from 0 to 3, with higher numbers indicating more gingival inflammation.
Plaque Index Score at Baseline
时间窗: Change between baseline at visit 1 and visit 2, six weeks post baseline
The quantity of plaque build-up is measured visually using the Quigley-Hein Plaque Index. The Plaque index can range from 0 to 5, with higher numbers indicating more plaque build-up.
Gingival Index Score at Baseline
时间窗: Change between baseline at visit 1 and visit 2, six weeks post baseline
The severity of gingival inflammation is measured visually using the Loe-Silness Gingival Index. Gingival index can range from 0 to 3, with higher numbers indicating more gingival inflammation.
次要结局
- DMFT Score at Baseline(Change between baseline at visit 1 and visit 2, six weeks post baseline)
- Subject Perception of Product Use(Visit 2 six weeks post study enrollment)
- DMFT Score at Baseline(Change between baseline at visit 1 and visit 2, six weeks post baseline)
- Subject Perception of Product Use(Visit 2 six weeks post study enrollment)