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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dental Caries Drug: 38% diammine silver fluoride Other: Water Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pragmatic Trial of Topical Diammine Silver Fluoride for Dental Caries Arrest
Study Start Date : January 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arms and Interventions
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Arm Intervention/treatment
Experimental: 38% diamine silver fluoride
Topical application of 38% diammine silver fluoride to active cavity
 Drug: 38% diammine silver fluoride
treatment of cavity with study agent
Other Names:
  • silver fluoride
  • silver diamine fluoride
Placebo Comparator: Water
Topical application of fluoride free water to active cavity
 Other: Water
Fluoride free, distilled water


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   24 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Nyvad criteria 3
  • Active carious lesion

Exclusion Criteria:

  • Allergy to silver
  • Stomatitis or oral ulcerative condition
  • Weight less than 15 kg
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02536040


Locations
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United States, Oregon
Advantage Dental Plans
Redmond, Oregon, United States, 97756
Sponsors and Collaborators
Advantage Dental Services, LLC
Investigators
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Study Director: Peter Milgrom, DDS Advantage Dental Plans
More Information
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Responsible Party: Advantage Dental Services, LLC
ClinicalTrials.gov Identifier: NCT02536040    
Other Study ID Numbers: 003
First Posted: August 31, 2015    Key Record Dates
Results First Posted: January 23, 2020
Last Update Posted: January 23, 2020
Last Verified: August 2016
Keywords provided by Advantage Dental Services, LLC:
silver diamine fluoride
diammine silver fluoride
children
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
 Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs