Status:
COMPLETED
Arginine Plaque Metabolism Pilot Clinical Study
Lead Sponsor:
Colgate Palmolive
Conditions:
Plaque, Dental
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Proof of concept clinical study to measure plaque metabolism and the prebiotic efficacy of arginine-containing toothpaste.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06954779
Start Date
July 24 2024
End Date
September 20 2024
Last Update
May 2 2025
Active Locations (1)
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1
Volpe Clinical Center
Piscataway, New Jersey, United States, 08854