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

PHASE2CompletedINTERVENTIONAL
Enrollment

2,000

Participants

Timeline

Start Date

January 21, 2021

Primary Completion Date

February 29, 2024

Study Completion Date

February 29, 2024

Conditions
Dental Caries
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

Trial Locations (9)

14214

University at Buffalo School of Dental Medicine, Buffalo

32610

University of Florida College of Dentistry, Gainesville

92350

Loma Linda University School of Dentistry, Loma Linda

46202-2876

Indiana University School of Dentistry, Indianapolis

02111

Tufts University School of Dental Medicine, Boston

02142

The Forsyth Institute, Boston

19104-6003

University of Pennsylvania School of Dental Medicine, Philadelphia

78229-3900

UT Health San Antonio School of Dentistry, San Antonio

Unknown

University of Puerto Rico School of Dental Medicine, San Juan

All Listed Sponsors
lead

Colgate Palmolive

INDUSTRY

NCT04750902 - 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 | Biotech Hunter | Biotech Hunter