Arginine Plaque Metabolism Pilot Clinical Study

April 24, 2025 updated by: Colgate Palmolive
Proof of concept clinical study to measure plaque metabolism and the prebiotic efficacy of arginine-containing toothpaste.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Piscataway, New Jersey, United States, 08854
        • Volpe Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Test 1 toothpaste
fluoride toothpaste
Drug: Colgate Cavity Protection
1000ppm fluoride
Experimental: Test 2 toothpaste
non fluoride toothpaste
Drug: TOM's Superior Sensitivity Relief Toothpaste
fluoride free

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque collection
Time Frame: baseline, week 3, week 4, week 6, week 7, week 8, week 9
Fasting plaque will be collected before and after a sucrose rinse for lactic acid analysis and ammonia production.The plaque pH of collected samples will also be measured to provide trend data.
baseline, week 3, week 4, week 6, week 7, week 8, week 9

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Saliva collection
Time Frame: week 5 and week 9
Differences in the arginine concentration in saliva pre- and post-brushing with treatment. Differences in microbiome composition and activity
week 5 and week 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colgate Palmolive

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2024

Primary Completion (Actual)

September 20, 2024

Study Completion (Actual)

September 20, 2024

Study Registration Dates

First Submitted

April 24, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 2, 2025

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRO-2023-SAL-05-EG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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