NCT05326373已完成不适用
A Pilot Study to Evaluate Gingivitis Using Traditional and Molecular Methods
Procter and Gamble1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年4月11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
- 40
- 试验地点
- 1
- 主要终点
- MGI
研究概览
简要总结
8-week study using stannous fluoride toothpaste on subjects with gingivitis ("unhealthy") and without gingivitis ("healthy"). Gingivitis index will be performed at BL, Week 4 and Week 8. A number of biological samples will be collected at each timepoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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 18 years of age or older;
- •Provide written informed consent and receive a signed copy of consent;
- •Agree to delay any elective dentistry, including dental prophylaxis, and to report any non-study dentistry received during the course of this study;
- •Agree not to participate in any other oral care studies for the duration of this study;
- •Agree to refrain from any form of non-specified oral hygiene during the treatment periods, including but not limited to the use of products such as floss or whitening products;
- •Agree to return for all scheduled visits and follow study procedures;
- •Have at least 16 natural teeth;
- •Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study.
- •For Unhealthy Group:
- •Have at least 20 bleeding sites (sites with a score of 1 or 2 on the Screening GBI exam); and
- •Have a minimum of 3 sampling sites with bleeding and pocket depth >/=3mm but not deeper than 4mm at the Screening visit.
- •For Healthy Group:
- •Have a maximum of 3 bleeding sites (sites with a score of 1 or 2 on the Screening GBI exam); and
- •No pockets deeper than 2mm.
排除标准
- •Self-reported pregnancy or the intent to become pregnant anytime during the course of the study;
- •Inability to comply with study procedures;
- •Rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment;
- •Severe periodontal disease, including but not limited to purulent exudate, generalized mobility, and/or severe recession;
- •Fixed orthodontic appliances or attachments for aligner treatment;
- •Having had a dental prophylaxis within 2 weeks of plaque sampling visits;
- •Having taken antibiotics or used anti-gingivitis/anti-bacterial oral care products such as chlorhexidine or Listerine within 2 weeks of plaque sampling visits;
- •Needing an antibiotic prophylaxis prior to dental visits;
- •Presenting with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study; or
- •Having any condition or disease, as determined by the Investigator/Designee which could be expected to interfere with examination procedures or with the subject's safe completion of the study.
研究组 & 干预措施
Healthy Group
Active Comparator
Subjects without gingivitis (</= 3 bleeding sites) will use stannous fluoride toothpaste
干预措施: Stannous fluoride (Drug)
Unhealthy Group
Active Comparator
Subjects with gingivitis (>/= bleeding 20 sites) will use stannous fluoride toothpaste
干预措施: Stannous fluoride (Drug)
结局指标
主要结局
MGI
时间窗: 8 weeks
Modified Gingival Index- validated assessment of gingival health looking at inflammation based on 4-point range 0 (normal gingiva) to 4 (severe inflammation).
GBI
时间窗: 8 weeks
Gingival Bleeding Index- validated assessment of gingival health looking at bleeding based on 2-point range 0 (Absence of bleeding) to 2 (Immediate bleeding)
次要结局
未报告次要终点
研究者
研究点 (1)
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