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Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Cavitated Caries Lesions

NCT03649659 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 830

Last updated 2025-01-07

Study results available
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Summary

This trial is a Phase III, multisite, randomized, placebo-controlled trial, with two parallel groups. The groups are SDF or placebo and they are applied every 6 months. The primary hypothesis of the trial is that SDF is better than placebo for stopping cavities with dentin exposed in baby teeth when assessed at 6 months after initial application.

Conditions

  • Cavities of Teeth

Interventions

DRUG

Silver Diamine Fluoride

SDF will be applied twice during the study

DRUG

Placebo

This is being compared to the SDF and will also be applied twice

Sponsors & Collaborators

Principal Investigators

  • Margherita Fontana, DDS, PhD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
71 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-08
Primary Completion
2023-04-11
Completion
2023-04-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03649659 on ClinicalTrials.gov