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 DMC FDA Drug

• 1 other identifier: CRO-2020-CAR-ARG-ED
• Study Type: interventional
• Target: 2,000
• 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)

• 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 Outcomes (5)

• Incremental subject-wise Decayed Missing Filled Surfaces (DFMS) score after 6-months of product use;

  after 6 months

• Incremental subject-wise Decayed Missing Filled Surfaces (DFMS) score between 6- months and one year of product use.

  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.

  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

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

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

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

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

Study Officials

• Maria E Ryan, DDS PhD

  Colgate-Palmolive Company

  STUDY DIRECTOR

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 29, 2024
• Study Completion: February 29, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); PR (1)