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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Caries
• Intervention / Treatment: Drug: 0.24% Sodium Fluoride Dentifrice; Drug: 1.5% Arginine Dentifrice; Drug: 4.0% Arginine Dentifrice; Drug: 8.0% Arginine Dentifrice

• Study Type: Interventional
• Enrollment (Actual): 2000
• Phase: Phase 2

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico
    • University of Puerto Rico School of Dental Medicine
• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University school of dentistry
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida College of Dentistry
  • Indiana
    • Indianapolis, Indiana, United States, 46202-2876
      • Indiana University School of Dentistry
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts University School of Dental Medicine
    • Boston, Massachusetts, United States, 02142
      • The Forsyth Institute
  • New York
    • Buffalo, New York, United States, 14214
      • University at Buffalo School of Dental Medicine
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-6003
      • University of Pennsylvania School of Dental Medicine
  • Texas
    • San Antonio, Texas, United States, 78229-3900
      • UT Health San Antonio School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects meeting all criteria below will be included in the study:

  1. Subject assent and parental/guardian informed consent for voluntary participation.
  2. Willingness and ability to use the assigned products according to instructions, availability for all appointments and likelihood of completing the clinical trial.
  3. Children ages 10-14 years at baseline.
  4. Presence of permanent second molars or evidence of at least one permanent second molar erupting as indicated by cuspal break through the mucosa.
  5. Good general health as evidenced by a review of the medical history.
  6. Subjects who, at study entry, have present two or more active caries lesions (ICDAS scores of 2 or greater) in permanent teeth and previous caries experience (DMFT >1), D= Decayed is defined as ICDAS scores of 3 or greater

Exclusion Criteria:

• Subjects presenting any of the criteria below will be excluded from the study:

  1. Presence of fixed or removable prosthetic appliance or orthodontic treatment involving more than four permanent teeth.

  2. Use of medication that could increase the risk of developing dental caries, i.e.

     medications that reduce saliva flow and those with high sugar content.

  3. Long-term antibiotic therapy.
  4. Children with a confirmed diagnosis of cognitive and/or motor impairment.
  5. Severe malocclusion.
  6. Subjects who, at study entry, have present severe caries (ICDAS 5 or 6) on five or more permanent teeth.
  7. Evidence of moderate to severe periodontal disease.
  8. Participation in any other clinical study within the 30 days preceding the start of the clinical study.
  9. Known history of allergies or other adverse reactions to arginine, or oral care products, or their ingredients.
  10. Self-reported history of being currently pregnant, intending to become pregnant during the trial period or breast-feeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 0.24% Sodium Fluoride Dentifrice; Toothpaste	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
Experimental: 1.5% Arginine Dentifrice; Toothpaste	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
Experimental: 4.0% Arginine Dentifrice; Toothpaste	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
Experimental: 8.0% Arginine Dentifrice; Toothpaste	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Surfaces (DMFS) score after one year of product use	the minimum score is 0, maximum score is 4/5 depending on the tooth number and a higher score represents a worse outcome	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incremental subject-wise Decayed Missing Filled Surfaces (DFMS) score after 6-months of product use;	the minimum score is 0, maximum score is 4/5 depending on the tooth number and a higher score represents a worse outcome	after 6 months
Incremental subject-wise Decayed Missing Filled Surfaces (DFMS) score between 6- months and one year of product use.	the minimum score is 0, maximum score is 4/5 depending on the tooth number and a higher score represents a worse outcome	between 6-months and one year
Clinically significant change in International Caries Detection and Assessment System (ICDAS) severity scores between the baseline and the six-month and one-year examinations and between the six-month and one-year examinations.	the minimum score is 0, maximum score is 6 and a higher score represents a worse outcome	between 6-months and one year
Clinically significant changes indicating caries progression are changes in ICDAS severity values from 0 to 2 or higher, from 1 or 2 to 3 or higher, or from 3 or 4 to 5 or 6.		6 months
Clinically significant changes indicating caries regression are changes in ICDAS severity values from 2 or higher to 0 or 1.		12 months

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Investigators: Study Director: Maria E Ryan, DDS PhD, Colgate-Palmolive Company

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2021
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: prevention; fluoride; caries; arginine; ICDAS; DMFS
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride
• Other Study ID Numbers: CRO-2020-CAR-ARG-ED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No