NCT07640399已完成不适用
Efficacy of a Stannous Fluoride Toothpaste in the Reduction and Treatment of Gingivitis: A Randomized Controlled Trial
Church & Dwight Company, Inc.1 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2025年3月17日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 1
研究概览
简要总结
This study evaluated the efficacy of a stannous fluoride toothpaste compared to a sodium fluoride control toothpaste in reducing gingivitis, bleeding, and plaque over a 12-week period.
A total of 132 subjects were randomized to one of two treatment groups and assessed at baseline and at Weeks 2, 4, 8, and 12 using standardized clinical indices, including the Modified Gingival Index (MGI), Bleeding Index (BI), and Plaque Index (PI).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects aged 18 to 65 years (inclusive)
- •Provided written informed consent prior to participation
- •Able to brush their own teeth on a daily basis
- •In good general health based on medical history review
- •Minimum of at least 18 natural, scorable teeth
- •Mean plaque index score ≥ 1.95
- •Mean baseline gingival index score ≥ 1.70 and ≤ 3.0
- •Agreed to refrain from use of all oral hygiene products other than those supplied for the study
- •Agreed to refrain from oral hygiene, eating, drinking, and chewing gum for approximately 12 hours prior to study visits
- •Agreed not to undergo dental prophylaxis or elective dental procedures during the study
- •Willing and able to comply with study procedures and visit schedule
排除标准
- •Physical limitations or restrictions that preclude normal tooth brushing
- •Requirement for premedication prior to dental treatment
- •Pregnancy or intent to become pregnant during the study period
- •Use of tobacco or nicotine products
- •Poor oral hygiene defined as >40 bleeding sites
- •Presence of dental caries or calculus deposits that may interfere with plaque assessments
- •Major oral hard or soft tissue lesions or trauma at baseline
- •Presence of fixed or removable orthodontic appliances
- •Dental prophylaxis within 1 month prior to baseline visit
- •History of significant adverse events, allergy, or irritation related to oral hygiene products
研究者
研究点 (1)
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