Building Adaptive School-based Interventions for Caries (BASICS)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Caries
• Intervention / Treatment: Device: Silver Diamine Fluoride (38%); Device: Glass Ionomer Sealant; Device: Fluoride Varnishes; Behavioral: Hygiene Intervention

Detailed Description

Dental caries is the world's most prevalent noncommunicable disease, with considerable health disparities found in low-income rural white children and low-income urban Hispanic/Latino and black children. To combat this silent epidemic, school-based caries prevention can increase access to critical dental care, reducing caries risk and mitigating its severe health and socioemotional consequences. However, despite the use of evidence-based interventions, approximately 30% of children participating in school-based caries prevention fail to respond to treatment ("nonresponse"), developing new caries and remaining at high risk for subsequent complications. Additionally, the sustainability of school-based prevention is jeopardized due to prohibitive costs, limitations of the professional workforce, and relying on treatments that are not optimized for individual patient needs. The Building Adaptive School-based Interventions for Caries (BASICS) study will develop and assess personalized, resource-efficient approaches to school caries prevention using adaptive interventions. Evaluated by embedding dynamic treatment regimes (DTR) within a Sequential, Multiple-Assignment, Randomized Trial (SMART) design, investigators will explore a number of hypotheses related to adaptive preventive interventions for caries. First, investigators will test the effects of adaptive interventions on reducing treatment nonresponse using generalized linear mixed models, followed by identifying the best dynamic treatment regime using augmented inverse probability weighted marginal structural models for causal effect estimation. Investigators will subsequently build an optimal adaptive intervention using Q-learning, tailoring treatments to individual patient attributes and responsiveness. Investigators will conclude with a microcosting analysis of the adaptive interventions, ultimately quantifying the intervention costs under different implementation scenarios and taking the first step towards understanding how much payers should reimburse for adaptive interventions. Successful completion of this project will produce resource-efficient adaptive prevention interventions (API) to reduce treatment nonresponse and improve oral health.

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ryan R Ruff, PhD, MPH; Phone Number: 212-998-9663; Email: ryan.ruff@nyu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subgroup A, SDF only; Single intervention: Silver diamine fluoride (SDF)	Device: Silver Diamine Fluoride (38%); Topically applied silver diamine fluoride 38% solution
Active Comparator: Subgroup D, Sealant only; Single intervention: Glass Ionomer Cement (GIC) Sealant	Device: Glass Ionomer Sealant; GIC Dental Sealants
Experimental: Subgroup B, SDF + FV + Hygiene Intervention; Nonresponse arm: SDF (First stage) + [SDF + Fluoride Varnish (FV) + Hygiene Intervention (Second Stage)]	Device: Silver Diamine Fluoride (38%); Topically applied silver diamine fluoride 38% solution; Device: Fluoride Varnishes; Topically applied fluoride varnish (FV); Behavioral: Hygiene Intervention; Behavioral intervention to improve dental hygiene
Experimental: Subgroup C, SDF + SMART + Sealant; Nonresponse arm: SDF (First Stage) + [Silver Modified Atraumatic Restorative Treatment (SMART) + Sealant (Second Stage)]	Device: Silver Diamine Fluoride (38%); Topically applied silver diamine fluoride 38% solution; Device: Glass Ionomer Sealant; GIC Dental Sealants
Experimental: Subgroup E, Sealant + SMART + FV + Hygiene Intervention; Nonresponse arm: GIC Sealant (First Stage) + [ART + FV + Hygiene Intervention (Second Stage)]	Device: Glass Ionomer Sealant; GIC Dental Sealants; Device: Fluoride Varnishes; Topically applied fluoride varnish (FV); Behavioral: Hygiene Intervention; Behavioral intervention to improve dental hygiene
Experimental: Subgroup F, Sealant + SMART; Nonresponse arm: GIC Sealant (First Stage) + [SMART (Second Stage)]	Device: Silver Diamine Fluoride (38%); Topically applied silver diamine fluoride 38% solution; Device: Glass Ionomer Sealant; GIC Dental Sealants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental Caries Incidence	Number of teeth presenting with new caries	Biannual assessment from enrollment to end of treatment (2.5 years)
Caries Prevalence	The prevalence of study participants with dental caries	Biannual assessment from enrollment to end of treatment (2.5 years)

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Ryan R Ruff, PhD, MPH, New York University College of Dentistry/Epidemiology

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Child; Prevention; Dental caries; SMART; Adaptive interventions; Dynamic treatment regimes
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: i24-01908; R01MD019938 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data dictionaries and de-identified patient data will be made available upon reasonable request and approval of a data use agreement.
• IPD Sharing Time Frame: IPD and supporting information will be available at the end of the trial for five years.
• IPD Sharing Access Criteria: Anyone with an approved data use agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes