Arginine Plaque Metabolism Pilot Clinical Study

NCT06954779 | Completed Phase 3 FDA Drug

• 1 other identifier: CRO-2023-SAL-05-EG
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Plaque, Dental

Keywords

saliva

Outcome Measures

Primary Outcomes (1)

• Plaque collection

  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 Outcomes (1)

• Saliva collection

  week 5 and week 9

Study Arms (2)

Test 1 toothpaste

ACTIVE COMPARATOR

fluoride toothpaste

Drug: Colgate Cavity Protection

Test 2 toothpaste

EXPERIMENTAL

non fluoride toothpaste

Drug: TOM's Superior Sensitivity Relief Toothpaste

Interventions

Colgate Cavity Protection DRUG

1000ppm fluoride

Test 1 toothpaste

TOM's Superior Sensitivity Relief Toothpaste DRUG

fluoride free

Test 2 toothpaste

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Volpe Clinical Center

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 2, 2025
• Study Start: July 24, 2024
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)