CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 41 enrolled
Drug / intervention
Silver Diamine Fluoride 38% +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/NCT02591147
NCT02591147N/ACompleted

Effectiveness of Silver Diamine Fluoride in Arresting Early Approximal Carious Lesion Progression: A Pilot Study

Justine Kolker·interventional·Posted Oct 29, 2015·Updated Mar 14, 2023

In Brief

A clinical study evaluating Silver Diamine Fluoride 38% and Group 2 (Placebo) for Dental Caries. Completed, enrolled 41 participants across 1 site.

Detailed Summary

This pilot trial is randomized, double-blind, and placebo-controlled trial with two parallel arms: an intervention group using silver diamine fluoride (SDF) and a placebo group (control). 60 eligible healthy adults will be enrolled in the study and randomly assigned to one of the two treatment groups. Both groups will receive the traditional preventive measures including cleanings, Fluoride varnish, diet analysis and counseling. Study participants will be followed for one year and caries progression will be radiographically monitored.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 29, 2015
Enrollment StartJan 7, 2016
Primary CompletionAug 1, 2021
Study CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 10.7 years ago

Interventions

Silver Diamine Fluoride 38%device

Group 1 (SDF group) subjects will receive the application of silver diamine fluoride (38% SDF solution) in addition to 5% Fluoride varnish to each approximal incipiency, using super floss, for a duration of 3 minutes under rubber dam isolation.

Group 2 (Placebo)device

Group 2 (Placebo) subjects will receive application of sterile water (placebo) in addition to 5% Fluoride varnish to each approximal incipiency, using super floss, for a duration of 3 minutes under rubber dam isolation.