NCT02536040

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 31, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

January 23, 2020

Completed
Last Updated

January 23, 2020

Status Verified

August 1, 2016

Enrollment Period

6 months

First QC Date

August 27, 2015

Results QC Date

January 6, 2020

Last Update Submit

January 13, 2020

Conditions

Dental Caries

Keywords

silver diamine fluoridediammine silver fluoridechildren

Outcome Measures

Primary Outcomes (1)

  • 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

    14-21 days

Study Arms (2)

38% diamine silver fluoride

EXPERIMENTAL

Topical application of 38% diammine silver fluoride to active cavity

Drug: 38% diammine silver fluoride

Water

PLACEBO COMPARATOR

Topical application of fluoride free water to active cavity

Other: Water

Interventions

38% diammine silver fluorideDRUG

treatment of cavity with study agent

Also known as: silver fluoride, silver diamine fluoride
38% diamine silver fluoride
WaterOTHER

Fluoride free, distilled water

Water

Eligibility Criteria

Age24 Months - 60 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Nyvad criteria 3
  • Active carious lesion

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advantage Dental Plans

Redmond, Oregon, 97756, United States

Location

MeSH Terms

Conditions

Dental Caries

Interventions

silver fluoridesilver diamine fluorideWater

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Results Point of Contact

Title
Peter Milgrom
Organization
Advantage Silver Dental Arrest, LLC
drmilgrom@silverarrest.com
2062516831

Study Officials

  • Peter Milgrom, DDS

    Advantage Dental Plans

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2015

First Posted

August 31, 2015

Study Start

January 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

January 23, 2020

Results First Posted

January 23, 2020

Record last verified: 2016-08

Locations

US(1)