Arginine Plaque Metabolism Pilot Clinical Study
Phase 3
Completed
- Conditions
- Plaque, Dental
- Interventions
- Drug: Colgate Cavity ProtectionDrug: TOM's Superior Sensitivity Relief Toothpaste
- Registration Number
- NCT06954779
- Lead Sponsor
- Colgate Palmolive
- Brief Summary
Proof of concept clinical study to measure plaque metabolism and the prebiotic efficacy of arginine-containing toothpaste.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Test 1 toothpaste Colgate Cavity Protection fluoride toothpaste Test 2 toothpaste TOM's Superior Sensitivity Relief Toothpaste non fluoride toothpaste
- Primary Outcome Measures
Name Time Method Plaque collection 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.
- Secondary Outcome Measures
Name Time Method Saliva collection week 5 and week 9 Differences in the arginine concentration in saliva pre- and post-brushing with treatment. Differences in microbiome composition and activity
Trial Locations
- Locations (1)
Volpe Clinical Center
🇺🇸Piscataway, New Jersey, United States