Efficacy Of A PVP-I Fluoride Varnish

Advantage Dental Services, LLC284 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

284

Conditions

Dental Caries

Interventions

Test varnishDRUG

Topical application of test varnish to the teeth 4 times per year.

Standard varnishDRUG

Topical application of test varnish to the teeth 4 times per year

Eligibility

Sex: ALLMin age: 60 MonthsMax age: 84 Months

Medical Language ↔ Plain English

Inclusion Criteria: 1. The subject's parent or legal guardian must provide signed and dated informed consent (parent permission form). 2. The subject's parent or legal guardian of the subject must be willing and able to comply with study requirements. 3. The subject is aged 60-84 months at the time of enrollment. 4. The subject must be in good general health as evidenced by parent report. Exclusion Criteria: 1. Known allergy to iodine 2. Known allergy to seafood 3. Known hypersensitivity to fluoride varnish 4. Diagnosis of thyroid disease 5. Chronic, prophylactic use of antibiotics 6. Treatment with another investigational drug or other intervention within 30 days preceding the Baseline Visit.

Locations (1)

Pohnpei State Hospital

Kolonia, Pohnpei State, Micronesia

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 24 months

Secondary Outcomes

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.

Time frame: After first treatment visit

Child Response to Fifth Treatment

Data from ClinicalTrials.gov

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