Safety Evaluation of Advantage Anti-Caries Varnish
- Conditions
- Dental Caries
- Interventions
- Drug: Varnish
- Registration Number
- NCT02645617
- Lead Sponsor
- Advantage Dental Services, LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- Healthy
- Weight less than 15 kg or hypersensitivity to iodine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Varnish Varnish Dental varnish containing povidone iodine and sodium fluoride
- Primary Outcome Measures
Name Time Method Soft Tissue within 48 hours Proportion of participants with any oral ulcerations OR inflammatory response
- Secondary Outcome Measures
Name Time Method Adverse Events within 48 hours Proportion of participants with any emergency medical care OR report of nausea OR not eating OR vomiting OR difficulty swallowing OR swelling around the mouth OR itchiness around the mouth OR hives OR rash OR stomach ache OR diarrhea
Trial Locations
- Locations (1)
University of Washington Regional Clinical Dental Research Center
🇺🇸Seattle, Washington, United States