Efficacy Of A PVP-I Fluoride Varnish

Advantage Dental Services

Status and phase: Completed; Phase 2

Conditions: Dental Caries

Treatments: Drug: Standard varnish; Drug: Test varnish

Study type: Interventional

Funder types: Industry

Identifiers

NCT03082196

2016-12-02

Details and patient eligibility

About

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.

Full description

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

Enrollment: 284 patients

Sex: All

Ages: 60 to 84 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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284 participants in 2 patient groups

Test varnish

Experimental group

Description:

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

Treatment:

Drug: Test varnish

Standard varnish

Active Comparator group

Description:

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.

Treatment:

Drug: Standard varnish