Metagenomic and Metatranscriptomic Analysis of Clinical Plaque Samples

Phase 2

Completed

• Conditions: Plaque
• Interventions: Drug: Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer; Drug: Colgate Cavity Protection

• Registration Number: NCT05138978
• Lead Sponsor: Colgate Palmolive

Brief 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.

Study Timeline

• Study Start: 2017-10-06
• Primary Completion: 2018-10-17
• Study Completion: 2018-10-17
• Status Verified: 2021-11
• Study First Submitted: 2021-11-16
• Study First Submitted QC: 2021-11-29
• Last Update Submitted: 2021-11-29
• Study First Posted: 2021-12-01
• Last Update Posted: 2021-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer	Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer	Toothpaste
Colgate Cavity Protection	Colgate Cavity Protection	Toothpaste

Primary Outcome Measures

Name	Time	Method
DNA (metagenomic) sequences	38 weeks	The primary outcome is to collect plaque following each treatment and to assess DNA
RNA (metatranscriptomic) sequences	38 weeks	The primary outcome is to collect plaque following each treatment and to assess RNA

Trial Locations

Locations (1)

King's College London Dental Institute, UK; 🇬🇧 London, United Kingdom