Search > Tooth Decay
1200 Participants NeededMy employer runs this trial

School-based Interventions for Tooth Decay

(BASICS Trial)

RR
Overseen ByRyan R Ruff, PhD, MPH
Age: < 18
Sex: Any
Trial Phase: Phase 3
Sponsor: New York University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Dental caries (tooth decay) is the world's most prevalent noncommunicable disease. Current preventive and therapeutic treatments are available that can be provided in a school-based health service environment. However, not all children respond to care, and school programs can result in under- or over-treatment, leaving children at high risk. The Building Adaptive School-based Interventions for Caries (BASICS) study will identify the optimal sequence and intensity of these treatments to minimize nonresponse, creating adaptive interventions tailored to specific needs in order to personalize school-based dental medicine.

Who Is on the Research Team?

RR

Ryan R Ruff, PhD, MPH

Principal Investigator

New York University College of Dentistry/Epidemiology

Are You a Good Fit for This Trial?

This trial is for children aged 5 to 13 who are enrolled in participating schools and have parental consent and their own agreement to join. It focuses on kids at risk of tooth decay or dental white spots.

Inclusion Criteria

Be enrolled in participating schools
Provide parental/guardian informed consent
Child assent
See 1 more

Exclusion Criteria

Known sensitivity to silver or other heavy-metal ions
Patients showing abnormal skin sensitization in daily circumstances
I have ulcers or sores in my mouth or gums.
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • Fluoride Varnishes
  • Glass Ionomer Sealant
  • Hygiene Intervention
  • Silver Diamine Fluoride (38%)

Trial Overview

The study tests different school-based dental treatments—silver diamine fluoride, glass ionomer sealants, hygiene education, and fluoride varnishes—to find the best way to prevent or treat tooth decay by personalizing care based on each child's needs.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Active Control

Group I: Subgroup F, Sealant + SMARTExperimental Treatment2 Interventions
Group II: Subgroup E, Sealant + SMART + FV + Hygiene InterventionExperimental Treatment3 Interventions
Group III: Subgroup C, SDF + SMART + SealantExperimental Treatment2 Interventions
Group IV: Subgroup B, SDF + FV + Hygiene InterventionExperimental Treatment3 Interventions
Group V: Subgroup A, SDF onlyExperimental Treatment1 Intervention
Group VI: Subgroup D, Sealant onlyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials
249
Recruited
229,000+

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials
473
Recruited
1,374,000+

Unbiased Results

We believe in providing patients with all the options.

Your Data Stays Your Data

We only share your information with the clinical trials you're trying to access.

Verified Trials Only

All of our trials are run by licensed doctors, researchers, and healthcare companies.