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Metagenomic and Metatranscriptomic Analysis of Clinical Plaque Samples

NCT ID: NCT05138978

Last Updated: 2021-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-06

Study Completion Date

2018-10-17

Brief Summary

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

Detailed Description

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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

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Plaque

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Each subject will be randomized.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer

Toothpaste

Group Type EXPERIMENTAL

Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer

Intervention Type DRUG

Toothpaste

Colgate Cavity Protection

Toothpaste

Group Type OTHER

Colgate Cavity Protection

Intervention Type DRUG

Toothpaste

Interventions

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Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer

Toothpaste

Intervention Type DRUG

Colgate Cavity Protection

Toothpaste

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Colgate Palmolive

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luciana Rinaudi-Marron, DR

Role: STUDY_DIRECTOR

Colgate Palmolive

Locations

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King's College London Dental Institute, UK

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ERO-2015-PLA-07-RPS

Identifier Type: -

Identifier Source: org_study_id