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OpenTrials
Completed

NCT Number: NCT02645617

Safety Evaluation of Advantage Anti-Caries Varnish

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

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

36 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Washington Regional Clinical Dental Research Center

Seattle, Washington, 98112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy

Exclusion criteria

  • Weight less than 15 kg or hypersensitivity to iodine

Treatment and study plan

Varnish

Drug

Topical application to the teeth

Other names: Advantage Anti-Caries Varnish

Primary outcomes

  1. Soft Tissue

    Time frame: within 48 hours

    Proportion of participants with any oral ulcerations OR inflammatory response

Secondary outcomes

  1. Adverse Events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Advantage Dental Services, LLC

Industry

Registry information

Official study title

Phase 1 Safety Evaluation of Advantage Anti-Caries Varnish

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 5, 2016
Registry last updated
Jan 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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