Safety Evaluation of Advantage Anti-Caries Varnish

Advantage Dental Services, LLC12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Dental Caries

Interventions

VarnishDRUG

Topical application to the teeth

Eligibility

Sex: ALLMin age: 36 MonthsMax age: 60 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy Exclusion Criteria: * Weight less than 15 kg or hypersensitivity to iodine

Locations (1)

University of Washington Regional Clinical Dental Research Center

Seattle, Washington, United States

Outcomes

Primary Outcomes

Soft Tissue

Proportion of participants with any oral ulcerations OR inflammatory response

Time frame: within 48 hours

Secondary Outcomes

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

Time frame: within 48 hours

Data from ClinicalTrials.gov

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