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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
Sponsor: Colgate Palmolive
Summary
The objective of this study is to assess the safety and to evaluate the anti-caries efficacy of COL101 (arginine) non-fluoride dentifrices compared to a 0.24% sodium fluoride dentifrice in 10-14 year-old children over a one year period.
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
Key Details
Gender
All
Age Range
10 Years - 14 Years
Study Type
INTERVENTIONAL
Enrollment
2025
Start Date
2021-01-21
Completion Date
2024-02-28
Last Updated
2026-07-21
Healthy Volunteers
Yes
Conditions
Interventions
0.24% Sodium Fluoride Dentifrice
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
1.5% Arginine Dentifrice
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
4.0% Arginine Dentifrice
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
8.0% Arginine Dentifrice
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
Locations (9)
Loma Linda University School of Dentistry
Loma Linda, California, United States
University of Florida College of Dentistry
Gainesville, Florida, United States
Indiana University School of Dentistry
Indianapolis, Indiana, United States
Tufts University School of Dental Medicine
Boston, Massachusetts, United States
The Forsyth Institute
Boston, Massachusetts, United States
University at Buffalo School of Dental Medicine
Buffalo, New York, United States
University of Pennsylvania School of Dental Medicine
Philadelphia, Pennsylvania, United States
UT Health San Antonio School of Dentistry
San Antonio, Texas, United States
University of Puerto Rico School of Dental Medicine
San Juan, Puerto Rico