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Safety Evaluation of Advantage Anti-Caries Varnish

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02645617
Recruitment Status : Unknown
Verified August 2016 by Advantage Dental Services, LLC.
Recruitment status was:  Recruiting
First Posted : January 5, 2016
Last Update Posted : August 9, 2016
Information provided by (Responsible Party):
Advantage Dental Services, LLC

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

Condition or disease Intervention/treatment Phase
Dental Caries Drug: Varnish Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 1 Safety Evaluation of Advantage Anti-Caries Varnish
Study Start Date : June 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Varnish
Dental varnish containing povidone iodine and sodium fluoride
Drug: Varnish
Topical application to the teeth
Other Name: Advantage Anti-Caries Varnish

Primary Outcome Measures :
  1. Soft tissue [ Time Frame: within 48 hours ]
    Presence of any oral ulcerations OR inflammatory response (Yes/No)

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: within 48 hours ]
    Report of 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

Information from the National Library of Medicine

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Ages Eligible for Study:   36 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • Weight less than 15 kg or hypersensitivity to iodine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02645617

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Contact: Peter Milgrom, DDS 206-251-6831

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United States, Washington
University of Washington Regional Clinical Dental Research Center Recruiting
Seattle, Washington, United States, 98112
Contact: Marilynn Rothen, MA    206-685-8132   
Sponsors and Collaborators
Advantage Dental Services, LLC
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Principal Investigator: Peter Milgrom, DDS Advantage Dental

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Responsible Party: Advantage Dental Services, LLC Identifier: NCT02645617     History of Changes
Other Study ID Numbers: PVP-I Varnish
First Posted: January 5, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs