MedTrace Logo

Comparative Effectiveness of School-based Caries Prevention

NCT03442309 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7418

Last updated 2025-02-26

Study results available
· View outcomes & findings →

Summary

Dental caries (tooth decay) is the most prevalent childhood disease in the world. Multiple interventions are available to treat and prevent caries. The aim of the proposed study is to compare the benefit of silver diamine fluoride (SDF) and fluoride varnish versus fluoride varnish and glass ionomer sealants. This study is a five-year, cluster randomized, pragmatic controlled trial conducted in public elementary schools in New York City.

Conditions

  • Dental Caries
  • Quality of Life

Interventions

DEVICE

Silver Diamine Fluoride

Silver diamine fluoride (SDF)

DEVICE

Fluoride Varnishes

Fluoride varnish (FV)

DEVICE

Glass Ionomer

Glass Ionomer Sealants (GC Fuji IX)

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Boston University

    collaborator OTHER

  • New York City Department of Health and Mental Hygiene

    collaborator OTHER_GOV

  • NYU College of Dentistry

    lead OTHER

Principal Investigators

  • Richard Niederman, DMD · NYU Langone Health

  • Ryan R Ruff, PhD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03442309 on ClinicalTrials.gov