NCT03936556已完成4 期
A 3-Month Clinical Study to Assess the Effects of a Stannous Fluoride Dentifrice on Plaque and Gingivitis
Procter and Gamble1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2018年2月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Löe-Silness Gingivitis Evaluation
研究概览
简要总结
The objective of this clinical study is to assess the effects of a 0.454% stannous fluoride dentifrice on gingivitis and plaque after 3 months when compared to a negative control.
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
- Triple (Participant, Investigator, 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 16 gradable teeth;
- •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 antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the Baseline Visit;
- •Have 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;
- •Removable oral appliances;
- •Fixed facial or lingual orthodontic appliances;
- •Self-reported pregnancy or lactation;
- •Any diseases or condition that might interfere with the safe participation in the study; and
- •Inability to undergo study procedures.
研究组 & 干预措施
Marketed Stannous Fluoride Paste
Experimental
Brush twice daily
干预措施: Marketed toothpaste (Drug)
Marketed Cavity Protection Toothpaste
Placebo Comparator
Brush twice daily
干预措施: Marketed Cavity Protection Toothpaste (Drug)
结局指标
主要结局
Löe-Silness Gingivitis Evaluation
时间窗: 3 Months
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
- Turesky Modified Quigley-Hein Index(3 Months)
研究者
研究点 (1)
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