NCT05138978

Metagenomic and Metatranscriptomic Analysis of Clinical Plaque Samples

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Colgate Palmolive · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to determine the metagenomic and metatranscriptomic analysis of clinical samples.

Detailed description

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.

Conditions

• Plaque

Interventions

Type	Name	Description
DRUG	Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer	Toothpaste
DRUG	Colgate Cavity Protection	Toothpaste

Timeline

• Start date: 2017-10-06
• Primary completion: 2018-10-17
• Completion: 2018-10-17
• First posted: 2021-12-01
• Last updated: 2021-12-01

Locations

1 site across 1 country: United Kingdom