A Clinical Trial to Assess the Safety and the Anti-caries Efficacy of COL 101 (Arginine) Non-fluoride Dentifrices in Comparison With 0.24% Sodium Fluoride (1100 Ppm F) Dentifrice Control in 10 to 14-year-old Children
Public ClinicalTrials.gov record NCT04750902. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Randomized, Double-blind, Active-controlled Multi-center Clinical Trial to Assess the Safety and the Anti-caries Efficacy of COL 101 (Arginine) Non-fluoride Dentifrices With 1.5%, 4.0% and 8.0% Arginine Each in Comparison With 0.24% Sodium Fluoride (1100 Ppm F) Dentifrice Control in 10 to 14-year-old Children
Study identification
- NCT ID
- NCT04750902
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Colgate Palmolive
- Industry
- Enrollment
- 2,025 participants
Conditions and interventions
Conditions
Interventions
- 0.24% Sodium Fluoride Dentifrice Drug
- 1.5% Arginine Dentifrice Drug
- 4.0% Arginine Dentifrice Drug
- 8.0% Arginine Dentifrice Drug
Drug
Eligibility (public fields only)
- Age range
- 10 Years to 14 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 20, 2021
- Primary completion
- Feb 27, 2024
- Completion
- Feb 27, 2024
- Last update posted
- Jul 20, 2026
2021 – 2024
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Loma Linda University School of Dentistry | Loma Linda | California | 92350 | — |
| University of Florida College of Dentistry | Gainesville | Florida | 32610 | — |
| Indiana University School of Dentistry | Indianapolis | Indiana | 46202-2876 | — |
| Tufts University School of Dental Medicine | Boston | Massachusetts | 02111 | — |
| The Forsyth Institute | Boston | Massachusetts | 02142 | — |
| University at Buffalo School of Dental Medicine | Buffalo | New York | 14214 | — |
| University of Pennsylvania School of Dental Medicine | Philadelphia | Pennsylvania | 19104-6003 | — |
| UT Health San Antonio School of Dentistry | San Antonio | Texas | 78229-3900 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04750902, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 20, 2026 · Synced Jul 24, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04750902 live on ClinicalTrials.gov.