Metagenomic and Metatranscriptomic Analysis of Clinical Plaque Samples
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- DNA (metagenomic) sequences
研究概览
简要总结
The objective of this study is to determine the metagenomic and metatranscriptomic analysis of clinical samples.
详细描述
This study is a blinded, non-randomized, crossover design. Subjects who meet the inclusion/exclusion criteria will be enrolled in the study. Following enrollment, subjects will be asked to use a washout dentifrice (#200000035883/001/000) for a minimum of 1 week. Fasting plaque will be collected at Baseline and then again at a duplicate baseline collection up to 1 week after the baseline collection. Subjects will be assigned a new dentifrice (#200000035883/001/000) to use for 12 weeks. After 12 weeks' use, fasting plaque will be collected. There will be a duplicate plaque collection up to 1 week after 12 week collection. Subjects will be given a new dentifrice (#200000040228/001/000) to use for the next 24 weeks. After 24 weeks' use, fasting plaque will be collected, and there will be a duplicate plaque collection up to 1 week after this collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer
Toothpaste
干预措施: Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer (Drug)
Colgate Cavity Protection
Toothpaste
干预措施: Colgate Cavity Protection (Drug)
结局指标
主要结局
DNA (metagenomic) sequences
时间窗: 38 weeks
The primary outcome is to collect plaque following each treatment and to assess DNA
RNA (metatranscriptomic) sequences
时间窗: 38 weeks
The primary outcome is to collect plaque following each treatment and to assess RNA
次要结局
未报告次要终点
