Efficacy Of A PVP-I Fluoride Varnish

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-30

Study Completion Date

2019-05-07

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.

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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

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-center, double-blind, controlled Phase 2 study with parallel groups of children.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

All study personnel except for designated personnel in the data center will be blinded to the participant treatment assignment. In order to maintain blinding, the caries scoring examinations will precede the application of test varnishes at baseline. The staff member applying these varnishes will not perform the caries scoring exams in order to eliminate examiner bias and ensure blinding to treatment assignment. Test drug and comparator are packaged identically.

Study Groups

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Test varnish

Advantage Anti-Caries Varnish. The active ingredients are Povidone Iodine and Sodium Fluoride .

Group Type EXPERIMENTAL

Test varnish

Intervention Type DRUG

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

Standard varnish

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.

Group Type ACTIVE_COMPARATOR

Standard varnish

Intervention Type DRUG

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

Interventions

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Test varnish

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

Intervention Type DRUG

Standard varnish

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

Intervention Type DRUG

Other Intervention Names

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sodium fluoride varnish

Eligibility Criteria

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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.

Minimum Eligible Age

60 Months

Maximum Eligible Age

84 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No