Safety Evaluation of Advantage Anti-Caries Varnish

Phase 1 Safety Evaluation of Advantage Anti-Caries Varnish

The purpose of the study is to confirm the safety of Advantage Anti-Caries Varnish.

This is an open-label Phase 1 study. The active ingredients are Povidone Iodine and Sodium Fluoride [Therametrics Technologies, Inc, Noblesville, IN, USA]. The oral soft tissues and teeth of the children will be examined and the test varnish to the teeth. The child will be re-examined at 24-48 hours for the presence of adverse oral soft tissue changes. At the follow-up, a qualified dental provider will ask questions focused on adverse events.

Inclusion Criteria:

• Healthy

Exclusion Criteria:

• Weight less than 15 kg or hypersensitivity to iodine