CompletedNot Applicable

Comparative Effectiveness of School-based Caries Prevention

United States7,418 participantsStarted 2019-02-01

Plain-language 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.

Who can participate

Age range5 Years – 12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Proportion of Subjects With All Caries Arrested

Timeframe: Two years

Prevalence of Dental Caries as Measured by a Clinical Oral Examination

Timeframe: Participants were evaluated biannually over a total of four years or until lost to follow-up, whichever occurred first.

Trial details

NCT IDNCT03442309

SponsorNYU College of Dentistry

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-30

Results submitted2024-06-24

View on ClinicalTrials.gov More Dental Caries trials