Arginine Plaque Metabolism Pilot Clinical Study

NCT ID: NCT06954779

Last Updated: 2025-05-02

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

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-24

Study Completion Date

2024-09-20

Brief Summary

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Proof of concept clinical study to measure plaque metabolism and the prebiotic efficacy of arginine-containing toothpaste.

Detailed Description

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Conditions

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Plaque, Dental

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Test 1 toothpaste

fluoride toothpaste

Group Type ACTIVE_COMPARATOR

Colgate Cavity Protection

Intervention Type DRUG

1000ppm fluoride

Test 2 toothpaste

non fluoride toothpaste

Group Type EXPERIMENTAL

TOM's Superior Sensitivity Relief Toothpaste

Intervention Type DRUG

fluoride free

Interventions

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Colgate Cavity Protection

1000ppm fluoride

Intervention Type DRUG

TOM's Superior Sensitivity Relief Toothpaste

fluoride free

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed Informed Consent Form.
* Male and female subjects aged 18-70 years, inclusive.
* Availability for the nine-week duration of the clinical research study.
* Good general health based on the opinion of the study investigator
* Good general health

Exclusion Criteria

* Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study.
* Five or more carious lesions requiring immediate care.
* Concurrent participation in any other oral care clinical study or test panel.
* Self-reported pregnant or lactating women.
* Dental prophylaxis received in the past four weeks prior to baseline examinations
* History of tobacco use-smoking, vaping and chewing tobacco
* Presence of orthodontic bands, presence of partial removable dentures
* Tumor(s) of the soft or hard tissues of the oral cavity
* Use of antibiotics or stain inducing medications any time during the two month prior to entry into the study
* Use of oral care products containing antimicrobials (Zn, Sn, CPC, triclosan, alcohol containing mouthwash, etc
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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

Locations

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Volpe Clinical Center

Piscataway, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CRO-2023-SAL-05-EG

Identifier Type: -

Identifier Source: org_study_id

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