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NCT02645617 Clinical Trial

Safety Evaluation of Advantage Anti-Caries Varnish

Dental Caries Clinical Trial

Official title:
Phase 1 Safety Evaluation of Advantage Anti-Caries Varnish

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02645617
Other study ID # PVP-I Varnish
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 30, 2016
Est. completion date October 20, 2016

Study information
Verified date January 2020
Source Advantage Dental Services, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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 information / eligibility
Status Completed
Enrollment 12
Est. completion date October 20, 2016
Est. primary completion date September 30, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 36 Months to 60 Months
Eligibility Inclusion Criteria:

- Healthy

Exclusion Criteria:

- Weight less than 15 kg or hypersensitivity to iodine

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Varnish
Topical application to the teeth

Locations
Country Name City State
United States University of Washington Regional Clinical Dental Research Center Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Advantage Dental Services, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Soft Tissue Proportion of participants with any oral ulcerations OR inflammatory response within 48 hours
Secondary Adverse Events 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 within 48 hours
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