Efficacy Of A PVP-I Fluoride Varnish

Study Overview
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Brief Summary
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The purpose of the study is to determine the efficacy of Advantage Anti-Caries Varnish. Single-center, double-blind, controlled Phase 2 study with parallel groups of children. Subjects will be stratified by early childhood education center and then randomized to receive either test varnish or control varnish topically to the teeth. Treatment will be administered quarterly for up to 24 months. The primary outcome is surface-level primary molar caries increment (d2-4mfs) at 24- months post baseline.

Detailed Description
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Objectives: Primary - To determine if Advantage Anti-Caries Varnish (test varnish) is superior to a control varnish containing only fluoride in the prevention of new caries lesions. Secondary To establish that the response of child participants to the test varnish was not inferior to the control varnish

Official Title
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Phase 2 Efficacy Evaluation Of Advantage Anti-Caries Varnish

Conditions
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Dental Caries

Intervention / Treatment
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* Drug: Test varnish
* Drug: Standard varnish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject's parent or legal guardian must provide signed and dated informed consent (parent permission form). The subject's parent or legal guardian of the subject must be willing and able to comply with study requirements. The subject is aged 60-84 months at the time of enrollment. The subject must be in good general health as evidenced by parent report. Exclusion Criteria: Known allergy to iodine Known allergy to seafood Known hypersensitivity to fluoride varnish Diagnosis of thyroid disease Chronic, prophylactic use of antibiotics Treatment with another investigational drug or other intervention within 30 days preceding the Baseline Visit.

Ages Eligible for Study
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Minimum Age: 60 Months
Maximum Age: 84 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Single-center, double-blind, controlled Phase 2 study with parallel groups of children.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test varnish<br>Advantage Anti-Caries Varnish. The active ingredients are Povidone Iodine and Sodium Fluoride . | Drug: Test varnish<br>* Topical application of test varnish to the teeth 4 times per year.<br>|
| Active Comparator: Standard varnish<br>The active control varnish will be the same fluoride varnish without iodine with an appropriate FDA approved food dye added to match the color of the test agent. There will be no difference in the treatment and control varnishes except for the povidone iodine. | Drug: Standard varnish<br>* Topical application of test varnish to the teeth 4 times per year<br>* Other names: sodium fluoride varnish;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental Caries for Primary Molars Sound at Baseline | The primary outcome will be the surface-level primary molar caries increment (d2-4mfs) at two years post baseline. Caries, as measured by d2-4mfs, is the total number of surfaces with decay into the enamel (2), dentin (3) or pulp (4), missing due to caries (m), or filled with amalgam, composite or other filling material (f). This scale records whether caries is detected in any of the 5 surfaces of the tooth for up to 8 primary molar teeth that were sound at baseline, and has a range of 0 to 40. Higher values indicate a greater number of caries. | 24 months | 
| Dental Caries for All Primary Teeth Sound at Baseline | The outcome will be the surface-level primary tooth caries increment (d2-4mfs) at two years post baseline that were sound at baseline. Caries, as measured by d2-4mfs, is the total number of surfaces with decay into the enamel (2), dentin (3) or pulp (4), missing due to caries (m), or filled with amalgam, composite or other filling material (f). This scale records whether caries is detected in any of the 4 or 5 surfaces of the tooth for up to 20 primary teeth that were sound at baseline, and has a range of 0 to 88. Higher values indicate a greater number of caries. The measure records whether caries is present on any of the 5 surfaces of the primary molars or 4 surfaces of the other teeth. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Response to First Treatment | Facial Images Scale which measures the child's response using a series of five happy/sad faces from a very unhappy face (5) to a very happy face (1). The minimum value is 1 which corresponds to a very happy face and the maximum value is 5 which corresponds to a very unhappy face. The possible values of the scale are 1, 2, 3, 4, or 5. | After first treatment visit | 
| Child Response to Fifth Treatment | Facial Images Scale which measures the child's response using a series of five happy/sad faces from a very unhappy face (5) to a very happy face (1). The minimum value is 1 which corresponds to a very happy face and the maximum value is 5 which corresponds to a very unhappy face. The possible values of the scale are 1, 2, 3, 4, or 5. | After fifth treatment visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sodium fluoride, povidone iodine, varnish