Efficacy Of A PVP-I Fluoride Varnish

• Status: Completed
• Trial end date: 2019-05-07
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Advantage Dental Services, LLC
• Treatments: Fluorides; Fluorides, Topical; Listerine; Povidone; Povidone-Iodine; Sodium Fluoride

Criteria

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.