Clinical Efficacy of an Experimental Toothpaste
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Change from baseline Bleeding Index at 24 weeks
研究概览
简要总结
The objective of this study is to evaluate the effect of an experimental toothpaste on maintaining gingival health over a 24 week period measured through modified gingival index, bleeding, plaque, and plaque bacteria. Prior to commencing study treatment, subjects will undergo a dental prophylaxis followed by a 2 week period of oral hygiene instruction and weekly professional tooth cleaning to bring the subjects to their optimum gingival health prior to commencing study treatment.
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
- Double (Participant, 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
- •Healthy subjects aged 18 years and older
- •A minimum of 20 permanent gradable teeth
- •For baseline eligibility, subjects must have a minimum Modified Gingival Index score of 1.5-2.3.
排除标准
- 未提供
研究组 & 干预措施
Experimental toothpaste
0.1% isopropylmethylphenol and 1150ppm fluoride
干预措施: isopropylmethylphenol and Fluoride (Drug)
Marketed toothpaste
NaF/Silica toothpaste containing 1150ppm fluoride
干预措施: Fluoride and Silica (Drug)
结局指标
主要结局
Change from baseline Bleeding Index at 24 weeks
时间窗: baseline to 24 weeks
Change from baseline Modified Gingival Index at 24 weeks
时间窗: baseline to 24 weeks
次要结局
- Change from baseline Modified Gingival Index at weeks 6 & 12(baseline to week 12)
- Change from baseline Bleeding Index at weeks 6 & 12(baseline to week 12)
- Change from baseline Plaque Index at weeks 6, 12 & 24(baseline to week 24)
- Change from baseline plaque bacteria at weeks 12 & 24(baseline to week 24)