Efficacy and Safety Evaluation of Anti-Caries Varnish

Study Overview
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Brief Summary
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The purpose of the study is to determine the efficacy & safety of Advantage Anti-Caries Varnish for primary prevention. The objectives are: 1) To determine if Advantage Anti-Caries Varnish (test varnish) is superior to an active control varnish (5% Sodium Fluoride, no Povidone-Iodine) in the prevention of caries lesions in the primary dentition. Specifically, prevention of caries lesions in primary teeth that either are sound, have only d1 (white spots) lesions or unerupted at baseline; and 2) To document the safety of the test varnish.

Detailed Description
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This is a single center randomized, double-blind, placebo-controlled, parallel-group trial. The treatment group will be exposed at baseline and once every three to four months after baseline for a maximum period of 24 months. The control group will be exposed to the control varnish in the same manner. 254 subjects will be enrolled. Half will be randomized to each arm. Subjects will be 10-20 mo of age and in good health. Children attending Maternal and Child Health (MCH) Immunization and Well Child programs in Pohnpei State will be enrolled. Primary Outcome Variables: 1) Surface-level dental caries lesions (d2-4mfs) at 24 months post baseline; 2) Presence/Absence of dental caries lesions (d2-4mfs >0) at 12 months post baseline. Secondary Outcome Variable: Adverse Events

Official Title
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Phase 2 Efficacy & Safety Evaluation of Advantage Anti-Caries Varnish for Primary Prevention

Conditions
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Dental Caries in Children

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


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 a 10-20 months at the time of enrollment. The subject must be in good general health as evidenced by parent report. The subject will have at least 1 erupted tooth that is either sound or has only a d1 (white spots) lesion. Exclusion Criteria: Previous treatment with fluoride varnish Known allergy to iodine Diagnosis of thyroid disease Chronic, prophylactic use of antibiotics Treatment with another investigational drug or intervention within 30 days preceding the Baseline Visit. Visible cavities (d2-4) Presence of intraoral pathology that would make assessment of post treatment soft tissue ulcerations or inflammation impossible (child could be enrolled if problem is treated and lesions cleared) Parent anticipates the child will move from Pohnpei during the next 2 years.

Ages Eligible for Study
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Minimum Age: 10 Months
Maximum Age: 20 Months

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
Interventional Model Description: This is a single center randomized, double-blind, placebo-controlled, parallel-group trial.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Varnish<br>Anti-Caries Varnish. The active ingredients are 10% (w/v) Povidone-Iodine and 5% (w/v) Sodium Fluoride CAS. | Drug: Test varnish<br>* A maximum of 0.2 mL will be applied to the teeth with a dental brush. Test or control varnish will be applied topically 4 times per year following enrollment and at each 3 to 4-month intervals.<br>* Other names: Advantage Anti-Caries Varnish;|
| Active Comparator: Control Varnish<br>Control Varnish. 5% (w/v) Sodium Fluoride . | Drug: Placebo<br>* A maximum of 0.2 mL will be applied to the teeth with a dental brush. Test or control varnish will be applied topically 4 times per year following enrollment and at each 3 to 4-month intervals.<br>* Other names: Fluoride Varnish;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries Increment | Surface-level dental caries lesions (d2-4mfs) at 24 months post baseline Surface-level dental caries lesions (d2-4mfs) at 24 months post baseline Surface-level dental caries lesions (d2-4mfs) at 24 months post baseline Surface-level dental caries lesions (d2-4mfs) at 24 months post baseline Surface-level dental caries lesions (d2-4mfs) | 24 months post baseline | 
| Caries Incidence | Presence/Absence of dental caries lesions (d2-4mfs >0) | 12 months post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Cumulative Adverse and Serious Adverse Events | 24 months post baseline | 

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