N/A
N=7,418
Comparative Effectiveness of School-based Caries Prevention
Dental Caries · Quality of Life
Bottom Line
View on ClinicalTrials.gov: NCT03442309 ↗Enrolled (actual)
7,418
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Proportion of Subjects With All Caries Arrested — 108; 101 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Silver Diamine Fluoride (Device); Fluoride Varnishes (Device); Glass Ionomer (Device)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- NYU College of Dentistry
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects With All Caries Arrested |
108; 101 | — |
| PRIMARY Prevalence of Dental Caries as Measured by a Clinical Oral Examination |
10.2; 9.8 | — |
| SECONDARY Oral Health-Related Quality of Life |
14.62; 16.47 | — |
| SECONDARY School Attendance |
-.037; -.037; 0 | — |
| SECONDARY Academic Performance |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Any primary school in New York City with a Hispanic/Latino student population greater than 50% and,
- A low-income population (defined as a student receiving free or reduced price lunch) of at least 80%.
- Within participating schools, all children are eligible to participate in the study.
Exclusion Criteria
- Schools that already have a pre-existing school-based dental health program.
- Within participating schools, exclusion criteria for children include those without informed consent or those with consent but without assent.
Data sourced from ClinicalTrials.gov (NCT03442309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.