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The Microbiology of Caries Resistance

NCT ID: NCT02130206

Last Updated: 2016-11-09

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

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-11-30

Brief Summary

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The purpose of this research study is to investigate the bacterial composition of plaque and saliva located in the mouth and associate that with risk factors that cause cavities.

Detailed Description

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Pre-Screening - If the subject chooses to be pre-screened for this study they will be asked to fill out a study registration form and an oral habits/medical history form. They will be asked to sign an Informed Consent. The subject will then have their teeth and gums examined. At this visit, the investigator will assess whether or not the subject is a good candidate for the study. During the phone interview each subject was asked not to brush or floss their teeth and not to eat or drink anything other than water for 8 hours prior to the pre-screening visit (Visit 0). If the subject was compliant with these requests, oral samples will be collected at this pre-screening visit and will now be considered Visit 1 (Baseline). If not, they will be asked to return to the clinic for another visit and asked not to brush or floss their teeth and not to eat or drink anything other than water 8 hours prior to that appointment. This visit will then be consider Visit 1 (Baseline).

Visit 1 (Baseline) - The subject will have their medical and dental history reviewed. They will have their teeth and gums examined. Saliva and plaque will be collected. Each subject will be given a toothbrush and toothpaste and instructed to not use any other dental products. This will be considered the "washout" period.

Visit 2 - The subject will be asked to return the unused toothpaste. Their medical and dental history will be reviewed and they will have their teeth examined. Saliva and plaque will be collected at this visit. The subjects will then be randomly assigned (by chance, like the flip of a coin) to the group that will use a marketed fluoride-containing toothpaste or to the group that will use a marketed arginine containing toothpaste. The subject will also be instructed not to brush or floss their teeth or eat or drink anything other than water for 8 hours prior to your next appointment.

Visits 3, 4, and 5 - Subjects will not be allowed to brush or floss their teeth or eat or drink anything other than water 8 hours prior to these visits. Saliva and plaque will be collected. On the 5th visit subjects will be asked to return the unused toothpaste tube. At this time participation in this research study will end and they will be instructed to return to their regular oral hygiene regiments.

Conditions

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Dental Caries

Keywords

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Plaque, Saliva, Cavities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Caries Free

Gums will be examined. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine.

Group Type ACTIVE_COMPARATOR

Caries Free

Intervention Type OTHER

Gums will be examined. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine.

Caries Free - Placebo

Gums will be examined. On some visits Saliva and plaque will be collected. Marketed Toothpaste will be assigned.

Group Type PLACEBO_COMPARATOR

Caries Free - Placebo

Intervention Type OTHER

Gums will be examined. On some visits Saliva and plaque will be collected. Marketed Toothpaste will be assigned.

Caries Active

Gums will be examined. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine.

Group Type ACTIVE_COMPARATOR

Caries Active

Intervention Type OTHER

Gums will be examined. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine.

Caries Active - Placebo

Gums will be examined. On some visits Saliva and plaque will be collected. Marketed Toothpaste will be assigned.

Group Type PLACEBO_COMPARATOR

Caries Active - Placebo

Intervention Type OTHER

Gums will be examined. On some visits Saliva and plaque will be collected. Marketed Toothpaste will be assigned.

Interventions

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Caries Free

Gums will be examined. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine.

Intervention Type OTHER

Caries Active

Gums will be examined. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine.

Intervention Type OTHER

Caries Free - Placebo

Gums will be examined. On some visits Saliva and plaque will be collected. Marketed Toothpaste will be assigned.

Intervention Type OTHER

Caries Active - Placebo

Gums will be examined. On some visits Saliva and plaque will be collected. Marketed Toothpaste will be assigned.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Twenty natural teeth excluding third molars
* No contraindications to dental treatment
* Caries Free
* Caries Active (at least two active sites)

Exclusion Criteria

* Less that twenty teeth
* Any systemic disease that can cause xerostomia
* Taking medications that cause xerostomia
* Antibiotics last three months
* Advanced Periodontal Disease
* Removable or fixed dental appliances
* Bleeding disorders or taking anticoagulant medications
* Immune compromised individuals
* Participating in another research study
* Used flavored products such as mint flavored candies and chewing gum one week prior to or during the study
* Uses tobacco products
* Unwilling or unable to provide Informed Consent and follow collection instructions
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Colgate Palmolive

INDUSTRY

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marcelle Nascimento, DDS, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida College of Dentistry

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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A-2013-197-OC

Identifier Type: OTHER

Identifier Source: secondary_id

665-2008

Identifier Type: -

Identifier Source: org_study_id