NCT03296657已完成不适用
A Pilot Study to Evaluate Stannous Fluoride in GCF and Subgingival Plaque
Procter and Gamble1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年8月23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
- 20
- 试验地点
- 1
- 主要终点
- Amount of tin in GCF sample
研究概览
简要总结
The amount of stannous fluoride in GCF and subgingival plaque samples will be analyzed.
详细描述
This is pilot study involving approximately 20 subjects with at least 20 dental pockets between 2- 4mm with bleeding for sampling. Subjects will have up to 10 sites identified as "sampling sites" that will have supragingival plaque, subgingival plaque, and gingival crevicular fluid (GCF) collected at Baseline, 30 minutes, 24 hours, and Week 2.
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 products and to refrain from using any other oral care products (including floss and mouth rinse) between the Acclimation 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 after 11 p.m. the night prior to each visit;
- •Agree to refrain from eating, chewing gum, drinking and using tobacco for 4 hours prior to each visit;
- •Have minimum 20 sampling sites with bleeding and pocket depth ≥2mm but not deeper than 4mm.
排除标准
- •Having a dental prophylaxis within 2 weeks of Acclimation visit;
- •Having rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment;
- •A medical condition requiring an antibiotic prophylaxis prior to dental visits;
- •A history of hypersensitivity to oral care products containing stannous fluoride; 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
stannous fluoride toothpaste
Experimental
0.454% stannous fluoride will be used twice a day, brushing for at least 1 minute for 2 weeks
干预措施: stannous fluoride (Drug)
结局指标
主要结局
Amount of tin in GCF sample
时间窗: mean difference from 30 minutes to baseline
per GCF sample amount of stannous level in ng/uL will be measured
次要结局
- Amount of tin in GCF and Subgingival Plaque(change from visit (change from 24 hours to baseline, change Week 2 to baseline))
研究者
研究点 (1)
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