Safety Evaluation of Advantage Anti-Caries Varnish
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 8/10/2016 |
| Start Date: | June 2016 |
| End Date: | December 2016 |
| Contact: | Peter Milgrom, DDS |
| Email: | peterm@advantagedental.com |
| Phone: | 206-251-6831 |
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.
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
We found this trial at
1
site
Seattle, Washington 98112
Phone: 206-685-8132
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