N/A
N=3,345
Comparative Effectiveness of Treatments to Prevent Dental Caries
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT03448107 ↗Enrolled (actual)
3,345
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Number of Participants With Arrested Dental Caries, Assessed Using a Clinical Oral Examination — 48; 53 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 Number of Participants With Arrested Dental Caries, Assessed Using a Clinical Oral Examination |
48; 53 | — |
| PRIMARY Caries Prevention |
210; 179 | — |
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 Hampshire.
Eligibility Criteria
Inclusion Criteria
- Any primary school with a previously employed caries prevention program operating in rural areas, with official Title 1 status, and located in a health professional shortage area. Within participating schools, all children are eligible to participate in the study. Those with informed consent and assent will receive care.
Exclusion Criteria
- Children without informed consent or those with consent but without assent.
Data sourced from ClinicalTrials.gov (NCT03448107). 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.