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

Sponsor

Colgate Palmolive (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04750902

Collaborator

(none)

2,000

Enrollment

Locations

Arms

19.3

Anticipated Duration (Months)

222.2

Patients Per Site

11.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Drug: 0.24% Sodium Fluoride Dentifrice Drug: 1.5% Arginine Dentifrice Drug: 4.0% Arginine Dentifrice Drug: 8.0% Arginine Dentifrice	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Jan 21, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loma Linda University School of Dentistry	Loma Linda	California	United States	92350
2	University of Florida College of Dentistry	Gainesville	Florida	United States	32610
3	Indiana University School of Dentistry	Indianapolis	Indiana	United States	46202-2876
4	Tufts University School of Dental Medicine	Boston	Massachusetts	United States	02111
5	The Forsyth Institute	Boston	Massachusetts	United States	02142
6	University at Buffalo School of Dental Medicine	Buffalo	New York	United States	14214
7	University of Pennsylvania School of Dental Medicine	Philadelphia	Pennsylvania	United States	19104-6003
8	UT Health San Antonio School of Dentistry	San Antonio	Texas	United States	78229-3900
9	University of Puerto Rico School of Dental Medicine	San Juan		Puerto Rico