CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 98 enrolled
Drug / intervention
Silver Diamine Fluoride +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02601833
NCT02601833Phase 3Completed

The Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques: A 12 Month Randomized Controlled Trial

University of Michigan·interventional·Posted Nov 10, 2015·Updated Nov 22, 2021

In Brief

A Phase 3 clinical trial evaluating Silver Diamine Fluoride and Conventional Caries Management for Caries. Completed, enrolled 98 participants across 2 sites.

Detailed Summary

The purpose of this study is to compare standard fillings and silver diamine fluoride (SDF) for treatment of cavities in baby teeth. The investigators will compare the effectiveness of stopping the cavity, cost of the treatments and the opinions of the families and the dental providers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCaries
CountriesUnited States

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 10, 2015
Enrollment StartJan 1, 2016
Primary CompletionSep 18, 2020
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 10.6 years ago

Interventions

Silver Diamine Fluoridedevice

No caries removal will take place. The tooth will be dried and Silver Diamine Fluoride will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet.

Conventional Caries Managementprocedure

These children will receive restorative dental care in alignment with the American Academy of Pediatric Dentistry guidelines, within the confines of the Mott Children's Health Center clinic. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration.