Efficacy Of A PVP-I Fluoride Varnish

Launched by ADVANTAGE DENTAL SERVICES, LLC · Mar 13, 2017

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility 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.