NCT02841839已完成不适用
A Pilot Study to Evaluate Sampling Methods for Subgingival Plaque
Procter and Gamble0 个研究点目标入组 20 人开始时间: 2016年6月最近更新:
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
- 20
- 主要终点
- Subgingival plaque
研究概览
简要总结
To identify a sampling method for collecting subgingival plaque
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Provide written informed consent to participate in the study;
- •Be 18 years of age or older;
- •Agree not to participate in any other oral/dental product studies during the course of this study;
- •Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed;
- •Agree to use the acclimation toothpaste together with their regular brush and refrain from any other oral care products (including floss and mouth rinse) between the Screening and Baseline Visit;
- •Agree to use the treatment products and refrain from any form of non-specified oral hygiene during the treatment periods (after the Baseline Visit), including but not limited to the use of products such as floss, mouth rinse, or whitening products;
- •Agree to return for all scheduled visits and follow study procedures;
- •Must 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;
- •Agree to refrain from all oral hygiene for at least 12 hours prior to each visit;
- •Agree to refrain from eating, chewing gum, drinking and using tobacco for 4 hours prior to each visit;
- •Have 10-20 bleeding sites; and
- •Have minimum 6 sampling sites with bleeding and pocket depth ≥2mm but not deeper than 4mm.
排除标准
- •Have had a dental prophylaxis within 2 weeks of plaque sampling visits;
- •Have taken antibiotics or used anti-gingivitis / anti-bacterial oral care products such as chlorhexidine or Listerine within 2 weeks of plaque sampling visits;
- •Have rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment;
- •Taking allergy medication or any other medication that can affect salivary flow such as an antihistamine;
- •Need an antibiotic prophylaxis prior to dental visits;
- •A history of hypersensitivity to oral care products containing hydrogen peroxide or stannous fluoride;
- •A history of hypersensitivity to products containing sodium lauryl sulfate (SLS);
- •Are pregnant (Self-reported) or lactating; or
- •Have any condition or disease, as determined by the Investigator/Designee based on a review of the medical history, 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
2-step system
Experimental
Subjects are to brush with 2-step system for 4 weeks; stannous fluoride
干预措施: Stannous Fluoride (Drug)
结局指标
主要结局
Subgingival plaque
时间窗: 4 weeks
subgingival plaque quantity measured by periopaper or curette sampling
次要结局
未报告次要终点
研究者
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