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 range

5 Years – 12 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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