Conditions: Dental Caries
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 12
Healthy volunteers: yes

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

Detailed description:
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.

Arms:
arm 1: Dental varnish containing povidone iodine and sodium fluoride

Interventions: intervention 1: Varnish
Intervention descriptions: intervention 1: Topical application to the teeth

Protocol document: