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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

NCT04750902 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2024-05-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Colgate Palmolive

    lead INDUSTRY

Principal Investigators

  • Maria E Ryan, DDS PhD · Colgate-Palmolive Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-21
Primary Completion
2024-02-29
Completion
2024-02-29
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04750902 on ClinicalTrials.gov