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NCT04750902 · ClinicalTrials.gov registry record · Phase 2

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 study of Dental Caries, sponsored by Colgate Palmolive.

Completed
Registry status
Phase 2
Development phase
2,000
Enrollment target
9
Study locations

NCT04750902 is a Phase 2 study of Dental Caries that has completed, run by Colgate Palmolive. The registered enrollment target is 2,000 participants, above the 655-participant average among 30 other Dental Caries trials with a reported enrollment target (205% higher). The trial reports 9 study locations across 8 states.

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The verdict

NCT04750902, a Phase 2 study of Dental Caries, has completed, sponsored by Colgate Palmolive.

COMPLETED
Registry status
Phase 2
Development phase
2,000 participants
Enrollment target
9
Study locations

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 Studied

Interventions

  • DRUG 0.24% Sodium Fluoride Dentifrice
  • DRUG 1.5% Arginine Dentifrice
  • DRUG 4.0% Arginine Dentifrice
  • DRUG 8.0% Arginine Dentifrice

Study Locations (9)

Massachusetts

  • Tufts University School of Dental Medicine - Boston
  • The Forsyth Institute - Boston

California

  • Loma Linda University School of Dentistry - Loma Linda

Florida

  • University of Florida College of Dentistry - Gainesville

Indiana

  • Indiana University School of Dentistry - Indianapolis

New York

  • University at Buffalo School of Dental Medicine - Buffalo

Pennsylvania

  • University of Pennsylvania School of Dental Medicine - Philadelphia

Texas

  • UT Health San Antonio School of Dentistry - San Antonio

Other

  • University of Puerto Rico School of Dental Medicine - San Juan

Trial Details

FieldValue
Enrollment Target 2,000 participants
Start Date 2021-01-21
Est. Completion 2024-02-29
Phase Phase 2

Sponsor

Colgate Palmolive

51 total trials

What the Registry Record Tells You About NCT04750902

The ClinicalTrials.gov registry entry for NCT04750902 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 655-participant average among 30 other Dental Caries trials with a reported enrollment target (205% higher). The listed sponsor is Colgate Palmolive, which has 51 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Dental Caries appearing as the primary indexed condition, and to 4 interventions - of which 0.24% Sodium Fluoride Dentifrice is the first listed.

NCT04750902 reports 9 study locations spanning 8 distinct geographic areas - top geographies include Massachusetts, California, Florida.

Frequently Asked Questions

What is clinical trial NCT04750902 about?

NCT04750902 is a clinical study titled "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". 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.

What is the current status of trial NCT04750902?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 2,000 participants. The study started on 2021-01-21. Estimated completion is 2024-02-29.

What conditions does trial NCT04750902 study?

This clinical trial studies the following conditions: Dental Caries.

What interventions are being tested in trial NCT04750902?

The interventions under investigation include: 0.24% Sodium Fluoride Dentifrice (DRUG), 1.5% Arginine Dentifrice (DRUG), 4.0% Arginine Dentifrice (DRUG), 8.0% Arginine Dentifrice (DRUG).

Who is sponsoring clinical trial NCT04750902?

This trial is sponsored by Colgate Palmolive, which has 51 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04750902 being conducted?

This trial has 9 study locations across California, Florida, Indiana, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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