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Stopping Cavities Study: Diammine Silver Fluoride

Primary Purpose

Dental Caries

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
38% diammine silver fluoride
Water
Sponsored by
Advantage Dental Services, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring silver diamine fluoride, diammine silver fluoride, children

Eligibility Criteria

24 Months - 60 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Nyvad criteria 3
  • Active carious lesion

Exclusion Criteria:

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

Sites / Locations

  • Advantage Dental Plans

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

38% diamine silver fluoride

Water

Arm Description

Topical application of 38% diammine silver fluoride to active cavity

Topical application of fluoride free water to active cavity

Outcomes

Primary Outcome Measures

Dental Caries Activity
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

Secondary Outcome Measures

Full Information

First Posted
August 27, 2015
Last Updated
January 13, 2020
Sponsor
Advantage Dental Services, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02536040
Brief Title
Stopping Cavities Study: Diammine Silver Fluoride
Official Title
Pragmatic Trial of Topical Diammine Silver Fluoride for Dental Caries Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advantage Dental Services, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
silver diamine fluoride, diammine silver fluoride, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
38% diamine silver fluoride
Arm Type
Experimental
Arm Description
Topical application of 38% diammine silver fluoride to active cavity
Arm Title
Water
Arm Type
Placebo Comparator
Arm Description
Topical application of fluoride free water to active cavity
Intervention Type
Drug
Intervention Name(s)
38% diammine silver fluoride
Other Intervention Name(s)
silver fluoride, silver diamine fluoride
Intervention Description
treatment of cavity with study agent
Intervention Type
Other
Intervention Name(s)
Water
Intervention Description
Fluoride free, distilled water
Primary Outcome Measure Information:
Title
Dental Caries Activity
Description
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
Time Frame
14-21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Nyvad criteria 3 Active carious lesion Exclusion Criteria: Allergy to silver Stomatitis or oral ulcerative condition Weight less than 15 kg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Milgrom, DDS
Organizational Affiliation
Advantage Dental Plans
Official's Role
Study Director
Facility Information:
Facility Name
Advantage Dental Plans
City
Redmond
State/Province
Oregon
ZIP/Postal Code
97756
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Stopping Cavities Study: Diammine Silver Fluoride

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