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Stopping Cavities Study: Diammine Silver Fluoride

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: NCT02536040
Recruitment Status : Completed
First Posted : August 31, 2015
Results First Posted : January 23, 2020
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Advantage Dental Services, LLC

Tracking Information
First Submitted Date  ICMJE August 27, 2015
First Posted Date  ICMJE August 31, 2015
Results First Submitted Date  ICMJE January 6, 2020
Results First Posted Date  ICMJE January 23, 2020
Last Update Posted Date January 23, 2020
Study Start Date  ICMJE January 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2020)		 Dental Caries Activity [ Time Frame: 14-21 days ]
Proportion of treated teeth with active decay that were arrested by the treatment measured using the Nyvad criterion code 6 reflecting hardness of the lesion and color change
Original Primary Outcome Measures  ICMJE
 (submitted: August 28, 2015)		 Caries activity [ Time Frame: 14-21 days ]
Nyvad criterion code 6
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stopping Cavities Study: Diammine Silver Fluoride
Official Title  ICMJE Pragmatic Trial of Topical Diammine Silver Fluoride for Dental Caries Arrest
Brief Summary This study is being conducted to test whether the use of diammine silver fluoride (also called silver diamine fluoride) hardens the cavity sufficiently so that it arrests.
Detailed Description Phase III RCT with two arms: (1) 38% diammine silver fluoride; (2) distilled fluoride free water. Subjects are 200 preschool children in good general health with untreated tooth decay. Intervention is topical application of the study drug to the open cavity. Primary outcome is caries activity at 14-21 days.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dental Caries
Intervention  ICMJE
  • Drug: 38% diammine silver fluoride
    treatment of cavity with study agent
    Other Names:
    • silver fluoride
    • silver diamine fluoride
  • Other: Water
    Fluoride free, distilled water
Study Arms  ICMJE
  • Experimental: 38% diamine silver fluoride
    Topical application of 38% diammine silver fluoride to active cavity
    Intervention: Drug: 38% diammine silver fluoride
  • Placebo Comparator: Water
    Topical application of fluoride free water to active cavity
    Intervention: Other: Water
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 Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2016)		 66
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2015)		 250
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Nyvad criteria 3
  • Active carious lesion

Exclusion Criteria:

  • Allergy to silver
  • Stomatitis or oral ulcerative condition
  • Weight less than 15 kg
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 24 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 NCT02536040
Other Study ID Numbers  ICMJE 003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Advantage Dental Services, LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Advantage Dental Services, LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Peter Milgrom, DDS Advantage Dental Plans
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