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 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CRO-2020-CAR-ARG-ED
• Study Type: interventional
• Target: 2,025
• Locations: 2 countries
• Sites: 9

Brief 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

Keywords

fluoride; arginine; prevention; caries; ICDAS; DMFS

Outcome Measures

Primary Outcomes (1)

• Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Baseline and the Month 12 Visits

  The Decayed Missing or Filled Surfaces (DMFS) score is a measure of the extent of dental caries for a subject, defined as the number of scorable tooth surfaces among the up to 128 examined surfaces in the subject's mouth that were determined by the examiner to be decayed, missing, or filled. This score can range between 0 and 128, with higher values indicating a greater level of disease (i.e., worse condition). The Incremental DMFS is defined as the change in DMFS score between two examinations performed at specified time points, calculated by subtraction.

  Between the Baseline and the Month 12 visits

Secondary Outcomes (17)

• Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Baseline and the Month 6 Visits

  Between the Baseline and the Month 6 visits

• Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Month 6 and Month 12 Visits

  Between the Month 6 and the Month 12 visits

• Incremental Subject-wise Decayed Missing or Filled Teeth (DMFT) Score Between the Baseline and the Month 6 Visits

  Between the Baseline and the Month 6 visits

• Incremental Subject-wise Decayed Missing or Filled Teeth (DMFT) Score Between the Baseline and the Month 12 Visits

  Between the Baseline and the Month 12 visits

• Incremental Subject-wise Decayed Missing or Filled Teeth (DMFT) Score Between the Month 6 and the Month 12 Visits

  Between the Month 6 and the Month 12 visits

Study Arms (4)

0.24% Sodium Fluoride Dentifrice

ACTIVE COMPARATOR

Toothpaste

Drug: 0.24% Sodium Fluoride Dentifrice

1.5% Arginine Dentifrice

EXPERIMENTAL

Toothpaste

Drug: 1.5% Arginine Dentifrice

4.0% Arginine Dentifrice

EXPERIMENTAL

Toothpaste

Drug: 4.0% Arginine Dentifrice

8.0% Arginine Dentifrice

EXPERIMENTAL

Toothpaste

Drug: 8.0% Arginine Dentifrice

Interventions

4.0% Arginine Dentifrice DRUG

Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study

4.0% Arginine Dentifrice

8.0% Arginine Dentifrice DRUG

Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study

8.0% Arginine Dentifrice

0.24% Sodium Fluoride Dentifrice DRUG

Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study

0.24% Sodium Fluoride Dentifrice

1.5% Arginine Dentifrice DRUG

Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study

1.5% Arginine Dentifrice

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects meeting all criteria below will be included in the study:
• Subject assent and parental/guardian informed consent for voluntary participation.
• Willingness and ability to use the assigned products according to instructions, availability for all appointments and likelihood of completing the clinical trial.
• Children ages 10-14 years at baseline.
• Presence of permanent second molars or evidence of at least one permanent second molar erupting as indicated by cuspal break through the mucosa.
• Good general health as evidenced by a review of the medical history.
• 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

You may not qualify if:

• Subjects presenting any of the criteria below will be excluded from the study:
• Presence of fixed or removable prosthetic appliance or orthodontic treatment involving more than four permanent teeth.
• 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.
• Long-term antibiotic therapy.
• Children with a confirmed diagnosis of cognitive and/or motor impairment.
• Severe malocclusion.
• Subjects who, at study entry, have present severe caries (ICDAS 5 or 6) on five or more permanent teeth.
• Evidence of moderate to severe periodontal disease.
• Participation in any other clinical study within the 30 days preceding the start of the clinical study.
• Known history of allergies or other adverse reactions to arginine, or oral care products, or their ingredients.
• Self-reported history of being currently pregnant, intending to become pregnant during the trial period or breast-feeding.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (9)

Loma Linda University School of Dentistry

Loma Linda, California, 92350, United States

Location

University of Florida College of Dentistry

Gainesville, Florida, 32610, United States

Location

Indiana University School of Dentistry

Indianapolis, Indiana, 46202-2876, United States

Location

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

The Forsyth Institute

Boston, Massachusetts, 02142, United States

Location

University at Buffalo School of Dental Medicine

Buffalo, New York, 14214, United States

Location

University of Pennsylvania School of Dental Medicine

Philadelphia, Pennsylvania, 19104-6003, United States

Location

UT Health San Antonio School of Dentistry

San Antonio, Texas, 78229-3900, United States

Location

University of Puerto Rico School of Dental Medicine

San Juan, Puerto Rico

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Domenick T. Zero (Principal Investigator)
• Organization: Indiana University School of Dentistry

dzero@iu.edu

317-274-5429

Study Officials

• Maria E Ryan, DDS PhD

  Colgate-Palmolive Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 11, 2021
• Study Start: January 21, 2021
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: July 21, 2026
• Results First Posted: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); PR (1)