Stopping Cavities Study: Diammine Silver Fluoride

January 13, 2020 updated by: Advantage Dental Services, LLC

Pragmatic Trial of Topical Diammine Silver Fluoride for Dental Caries Arrest

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

66

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Redmond, Oregon, United States, 97756
        • Advantage Dental Plans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Nyvad criteria 3
  • Active carious lesion

Exclusion Criteria:

  • Allergy to silver
  • Stomatitis or oral ulcerative condition
  • Weight less than 15 kg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 diamine fluoride
  • silver fluoride
Placebo Comparator: Water
Topical application of fluoride free water to active cavity
Other: Water
Fluoride free, distilled water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14-21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advantage Dental Services, LLC

Investigators

  • Study Director: Peter Milgrom, DDS, Advantage Dental Plans

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

August 27, 2015

First Submitted That Met QC Criteria

August 28, 2015

First Posted (Estimate)

August 31, 2015

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 13, 2020

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 003 (NuSkin International)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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