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

Phase 2

Completed

• Conditions: Dental Caries
• Interventions: Drug: 0.24% Sodium Fluoride Dentifrice; Drug: 8.0% Arginine Dentifrice; Drug: 1.5% Arginine Dentifrice; Drug: 4.0% Arginine Dentifrice

• Registration Number: NCT04750902
• Lead Sponsor: Colgate Palmolive

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-21
• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-11
• Primary Completion: 2024-02-29
• Study Completion: 2024-02-29
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.24% Sodium Fluoride Dentifrice	0.24% Sodium Fluoride Dentifrice	Toothpaste
8.0% Arginine Dentifrice	8.0% Arginine Dentifrice	Toothpaste
1.5% Arginine Dentifrice	1.5% Arginine Dentifrice	Toothpaste
4.0% Arginine Dentifrice	4.0% Arginine Dentifrice	Toothpaste

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Incremental subject-wise Decayed Missing Filled Surfaces (DFMS) score after 6-months of product use;	after 6 months	the minimum score is 0, maximum score is 4/5 depending on the tooth number and a higher score represents a worse outcome
Incremental subject-wise Decayed Missing Filled Surfaces (DFMS) score between 6- months and one year of product use.	between 6-months and one year	the minimum score is 0, maximum score is 4/5 depending on the tooth number and a higher score represents a worse outcome
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	the minimum score is 0, maximum score is 6 and a higher score represents a worse outcome

Trial Locations

Locations (9)

Indiana University School of Dentistry; 🇺🇸 Indianapolis, Indiana, United States

Loma Linda University School of Dentistry; 🇺🇸 Loma Linda, California, United States

University of Florida College of Dentistry; 🇺🇸 Gainesville, Florida, United States

Tufts University School of Dental Medicine; 🇺🇸 Boston, Massachusetts, United States

The Forsyth Institute; 🇺🇸 Boston, Massachusetts, United States

University at Buffalo School of Dental Medicine; 🇺🇸 Buffalo, New York, United States

University of Pennsylvania School of Dental Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States

UT Health San Antonio School of Dentistry; 🇺🇸 San Antonio, Texas, United States

University of Puerto Rico School of Dental Medicine; 🇵🇷 San Juan, Puerto Rico