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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04750902
• Other study ID #: CRO-2020-CAR-ARG-ED
• Status: Completed
• Phase: Phase 2
• Start date: January 21, 2021
• Est. completion date: February 29, 2024

Study information

• Verified date: May 2024
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries

Intervention

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
• 1.5% Arginine Dentifrice
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
• 4.0% Arginine Dentifrice
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
• 8.0% Arginine Dentifrice
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico School of Dental Medicine	San Juan
United States	The Forsyth Institute	Boston	Massachusetts
United States	Tufts University School of Dental Medicine	Boston	Massachusetts
United States	University at Buffalo School of Dental Medicine	Buffalo	New York
United States	University of Florida College of Dentistry	Gainesville	Florida
United States	Indiana University School of Dentistry	Indianapolis	Indiana
United States	Loma Linda University School of Dentistry	Loma Linda	California
United States	University of Pennsylvania School of Dental Medicine	Philadelphia	Pennsylvania
United States	UT Health San Antonio School of Dentistry	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Clinically significant changes indicating caries regression are changes in ICDAS severity values from 2 or higher to 0 or 1.		12 months