2-year Caries Clinical Study: Arginine Fluoride-Free Toothpastes vs. NaF Toothpaste

Study Overview
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Brief Summary
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The objective of this study is to evaluate the anticaries efficacy for three dentifrices (1.5% arginine in a calcium base, 8.0% arginine in a calcium base, and 0.32% sodium fluoride in a silica base) in a two-year caries clinical study

Official Title
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Clinical Investigation Examining the Anticaries Efficacy of Three Dentifrices (1.5% Arginine in a Calcium Base, 8.0% Arginine in a Calcium Base, and 0.32% Sodium Fluoride in a Silica Base): a Two-year Caries Clinical Study

Conditions
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Dental Caries

Intervention / Treatment
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* Drug: 0.32% Sodium Fluoride Dentifrice Toothpaste
* Drug: 1.5% Arginine Dentifrice
* Drug: 8.0% Arginine Dentifrice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent Form signed by parent or legal guardian to permit participation of their child in the study 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 second molars or evidence of erupting permanent molars. Subjects should be of good general health as evidenced by a review of the medical history. Presence of two or more active caries lesions (ICDAS scores of 2 or greater) and with a previous caries experience (DMFS ≥ 2). Exclusion Characteristics Subjects presenting with 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. medication that reduces saliva flow. Long-term antibiotic therapy. Children with cognitive and/or motor impairment. Severe malocclusion. Presence of severe caries (ICDAS 5 or 6) on five or more teeth. Evidence of moderate to severe periodontal disease. Participation in any other clinical study within the 30 days preceding the clinical study. History of allergies or other adverse reactions to arginine, or oral care products, or their ingredients. Pregnant or lactating.

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: 0.32% Sodium Fluoride Dentifrice Toothpaste<br>Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study | Drug: 0.32% Sodium Fluoride Dentifrice Toothpaste<br>* Toothpaste<br>|
| Experimental: 1.5% Arginine Dentifrice Toothpaste<br>Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study | Drug: 1.5% Arginine Dentifrice<br>* Toothpaste<br>|
| Experimental: 8.0% Arginine Dentifrice Toothpaste<br>Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study | Drug: 8.0% Arginine Dentifrice<br>* Toothpaste<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 score after 2 year 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 | 2 year | 
| The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Teeth scores after two 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 | 2 year | 

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