Stopping Cavities Study: Diammine Silver Fluoride

NCT ID: NCT02536040

Last Updated: 2020-01-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Caries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

38% diamine silver fluoride

Topical application of 38% diammine silver fluoride to active cavity

Group Type EXPERIMENTAL

38% diammine silver fluoride

Intervention Type DRUG

treatment of cavity with study agent

Water

Topical application of fluoride free water to active cavity

Group Type PLACEBO_COMPARATOR

Water

Intervention Type OTHER

Fluoride free, distilled water

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

38% diammine silver fluoride

treatment of cavity with study agent

Intervention Type DRUG

Water

Fluoride free, distilled water

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

silver fluoride silver diamine fluoride

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Nyvad criteria 3
* Active carious lesion

Exclusion Criteria

* Allergy to silver
* Stomatitis or oral ulcerative condition
* Weight less than 15 kg
Minimum Eligible Age

24 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Advantage Dental Services, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter Milgrom, DDS

Role: STUDY_DIRECTOR

Advantage Dental Plans

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Advantage Dental Plans

Redmond, Oregon, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.