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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.
ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Advantage Dental Services, LLC

Tracking Information
First Submitted Date  ICMJE December 28, 2015
First Posted Date  ICMJE January 5, 2016
Last Update Posted Date August 9, 2016
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 31, 2015)
Soft tissue [ Time Frame: within 48 hours ]
Presence of any oral ulcerations OR inflammatory response (Yes/No)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02645617 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 31, 2015)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Evaluation of Advantage Anti-Caries Varnish
Official Title  ICMJE Phase 1 Safety Evaluation of Advantage Anti-Caries Varnish
Brief Summary The purpose of the study is to confirm the safety of Advantage Anti-Caries Varnish.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Dental Caries
Intervention  ICMJE Drug: Varnish
Topical application to the teeth
Other Name: Advantage Anti-Caries Varnish
Study Arms  ICMJE Experimental: Varnish
Dental varnish containing povidone iodine and sodium fluoride
Intervention: Drug: Varnish
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 31, 2015)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • Weight less than 15 kg or hypersensitivity to iodine
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 36 Months to 60 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02645617
Other Study ID Numbers  ICMJE PVP-I Varnish
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Advantage Dental Services, LLC
Study Sponsor  ICMJE Advantage Dental Services, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Milgrom, DDS Advantage Dental
PRS Account Advantage Dental Services, LLC
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP