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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2,000 (actual)
• Sponsor: Colgate Palmolive · Industry
• Sex: All
• Age: 10 Years – 14 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Caries

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-01-21
• Primary completion: 2024-02-29
• Completion: 2024-02-29
• First posted: 2021-02-11
• Last updated: 2024-05-16

Locations

9 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study