Metagenomic and Metatranscriptomic Analysis of Clinical Plaque Samples

Study Overview
=================
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.

Official Title
-----------------
Metagenomic and Metatranscriptomic Analysis of Clinical Plaque Samples

Conditions
-----------------
Plaque

Intervention / Treatment
-----------------
* Drug: Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer
* Drug: Colgate Cavity Protection


Participation Criteria
=================
Eligibility 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)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each subject will be randomized.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer<br>Toothpaste | Drug: Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer<br>* Toothpaste<br>|
| Other: Colgate Cavity Protection<br>Toothpaste | Drug: Colgate Cavity Protection<br>* Toothpaste<br>|

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 |