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COMPLETED
NCT04750902
PHASE2

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

View on ClinicalTrials.gov

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

DRUG

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

DRUG

1.5% Arginine Dentifrice

Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study

DRUG

4.0% Arginine Dentifrice

Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study

DRUG

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