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临床试验/NCT05138978
NCT05138978已完成2 期

Metagenomic and Metatranscriptomic Analysis of Clinical Plaque Samples

Colgate Palmolive1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2017年10月6日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Toothpaste

干预措施: Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer (Drug)

Colgate Cavity Protection

Other

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

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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