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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Dental Caries

Intervention / Treatment
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* Drug: 0.24% Sodium Fluoride Dentifrice
* Drug: 1.5% Arginine Dentifrice
* Drug: 4.0% Arginine Dentifrice
* Drug: 8.0% Arginine Dentifrice


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.24% Sodium Fluoride Dentifrice<br>Toothpaste | Drug: 0.24% Sodium Fluoride Dentifrice<br>* Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study<br>|
| Experimental: 1.5% Arginine Dentifrice<br>Toothpaste | Drug: 1.5% Arginine Dentifrice<br>* Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study<br>|
| Experimental: 4.0% Arginine Dentifrice<br>Toothpaste | Drug: 4.0% Arginine Dentifrice<br>* Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study<br>|
| Experimental: 8.0% Arginine Dentifrice<br>Toothpaste | Drug: 8.0% Arginine Dentifrice<br>* Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluoride, arginine, prevention, caries, ICDAS, DMFS