Adaptive school-based interventions to prevent dental caries in children
Official title: The Building Adaptive School-based Interventions for Caries Study (BASICS): A Phase III Sequential, Multiple-Assignment, Randomized Trial of Minimally Invasive Therapies to Reduce Treatment Nonresponse
Run by University of Pennsylvania · NCT07265830 · Data updated 2026-11-12
This study tests personalized, stepwise prevention strategies in schools to see if they can reduce tooth decay in children aged 5–13.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 5 Years to 13 Years |
| Sex | All |
| Enrollment | 1200 (estimated) |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Glenwood Springs, Colorado) |
| Status | Recruiting |
| Started | August 18, 2026 |
| Main results expected | June 2030 |
| Study ends | June 2030 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT07265830 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are ages 5–13 enrolled in participating schools, with parental consent and child assent, and without exclusions related to active gingival or stomatal conditions or extensive caries requiring more invasive treatment.
✕Probably not a fit
Children with certain conditions or extensive disease might not experience benefit from the preventive interventions tested and may require alternative care.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
BASICS uses a SMART design to tailor preventive care for dental caries delivered in school settings, embedding dynamic treatment regimes to find the most effective sequence and intensity of interventions. The trial includes interventions such as silver diamine fluoride, glass ionomer sealants, fluoride varnishes, and hygiene support, with a focus on reducing nonresponse and optimizing resource use. Participants are children in participating schools, assessed for response to treatment and guided through adaptive pathways based on their needs. The study emphasizes addressing health disparities by testing personalized approaches in diverse populations and school environments.
Why it matters
Potential benefit: If successful, the adaptive approach could lead to more effective, personalized prevention, reducing new caries and improving oral health for children in school programs.
How similar studies have gone: Previous school-based caries prevention programs show varied success; BASICS aims to improve outcomes by personalizing treatment sequences, which is relatively novel in this setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Be enrolled in participating schools 2. Be between the ages of 5 and 13 years 3. Provide parental/guardian informed consent 4. Child assent Exclusion Criteria: 1. Ulcerative gingivitis or stomatitis 2. Known sensitivity to silver or other heavy-metal ions 3. More than six affected sites 4. Those who have had full mouth gingivectomies 5. Patients showing abnormal skin sensitization in daily circumstances 6. Those who have had pulp capping
Where it's running
-
Smiles For Students
Glenwood Springs, Colorado, United States Recruiting
Study contacts
- Principal investigator: Ryan R Ruff, PhD, MPH — New York University College of Dentistry/Epidemiology
- Study coordinator: Ryan R Ruff, PhD, MPH
- Email: ryan.ruff@nyu.edu
- Phone: 212-998-9663
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.