Metagenomic and Metatranscriptomic Analysis of Clinical Plaque Samples

Colgate-Palmolive

Status and phase

Completed

Phase 2

Conditions

Plaque

Treatments

Drug: Colgate Cavity Protection

Drug: Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer

Study type

Interventional

Funder types

Industry

Identifiers

NCT05138978

ERO-2015-PLA-07-RPS

Details and patient eligibility

About

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

Full 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.

Enrollment

34 patients

Sex

All

Ages

16+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)