Metagenomic and Metatranscriptomic Analysis of Clinical Plaque Samples

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

Study Overview

• Status: Completed
• Conditions: Plaque
• Intervention / Treatment: Drug: Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer; Drug: Colgate Cavity Protection

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • King's College London Dental Institute, UK

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Male and/or female subjects 16 years and above
• Minimum of 20 natural uncrowned teeth (excluding third molars) must be present
• Caries active subjects will have at least 3 active caries lesions (ICDAS score 1 - 3). Caries free control subjects will either have ICDAS score 0 or ICDAS score of 1 - 3 where the lesion is inactive.
• Available throughout entire study
• Willing to use only assigned products for oral hygiene throughout the duration of the study
• Must give written informed consent
• Must be in good general health

Exclusion Criteria

• Unwilling or unable to sign an Informed Consent Form
• Advanced periodontal disease
• Medical condition which requires premedication prior to dental visits/procedures
• Diseases of the soft or hard oral tissues
• Orthodontic appliances that interfere with clinical assessments
• Impaired salivary function
• Current use of drugs that can affect salivary flow
• Use antibiotics 3 months prior to or during this study
• Use of any arginine containing oral care products such as Colgate Sensitive Pro-Relief and Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer dentifrices 3 months prior to or during this study
• Pregnant or breastfeeding
• Participate in another clinical study 1 week prior to the start of the washout period or during the study period
• Use of tobacco products
• Allergic to common dentifrice ingredients
• Allergic to amino acids
• Immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer; Toothpaste	Drug: Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer; Toothpaste
Other: Colgate Cavity Protection; Toothpaste	Drug: Colgate Cavity Protection; Toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DNA (metagenomic) sequences	The primary outcome is to collect plaque following each treatment and to assess DNA	38 weeks
RNA (metatranscriptomic) sequences	The primary outcome is to collect plaque following each treatment and to assess RNA	38 weeks

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Investigators: Study Director: Luciana Rinaudi-Marron, DR, Colgate Palmolive

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2017
• Primary Completion (Actual): October 17, 2018
• Study Completion (Actual): October 17, 2018

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: November 29, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Sodium Fluoride
• Other Study ID Numbers: ERO-2015-PLA-07-RPS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No