NCT05916521已完成不适用
A Three-Month Bleeding-Model Clinical Study
Procter and Gamble1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年11月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Löe-Silness Gingivitis Evaluation
研究概览
简要总结
The objective of the study is to evaluate the gingivitis control benefit of an established stannous fluoride containing toothpaste relative to a negative control dentifrice.
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)
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
- •Be at least 18 years of age;
- •Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- •Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
- •Have at least 20 gradable teeth;
- •Have established gingivitis with 10-70% bleeding sites;
- •Agree to return for scheduled visits and follow the study procedures;
- •Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
- •Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study.
排除标准
- •Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit;
- •Having any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
- •Having known hypersensitivity to the test products;
- •Having removable oral appliances;
- •Having fixed facial or lingual orthodontic appliances;
- •Self-reported pregnancy or lactation;
- •Having any diseases or condition that might interfere with the safe participation in the study;
- •Having an inability to undergo study procedures.
研究组 & 干预措施
Positive Control
Active Comparator
2 brushings per day (AM and PM)
干预措施: 0.454% stannous fluoride (Drug)
Negative Control
Sham Comparator
2 brushings per day (AM and PM)
干预措施: 0.76% sodium monofluorophosphate (Drug)
Experimental Control
Experimental
Brush with Positive control in the morning and negative control in the evening
干预措施: 0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM (Drug)
结局指标
主要结局
Löe-Silness Gingivitis Evaluation
时间窗: Week 12
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
次要结局
未报告次要终点
研究者
研究点 (1)
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