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Building Adaptive School-based Interventions for Caries

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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07265830
Acronym
BASICS
Enrollment
1200
Registered
2025-12-05
Start date
2026-09-01
Completion date
2030-06-01
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

Dental caries, Adaptive interventions, Prevention, Child, Dynamic treatment regimes, SMART

Brief summary

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.

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.

Interventions

Topically applied silver diamine fluoride 38% solution

GIC Dental Sealants

Topically applied fluoride varnish (FV)

BEHAVIORALHygiene Intervention

Behavioral intervention to improve dental hygiene

Sponsors

University of Pennsylvania
Lead SponsorOTHER
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

BASICS is a phase-III Sequential, Multiple-Assignment, Randomized Trial (SMART)

Eligibility

Sex/Gender
ALL
Age
5 Years to 13 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Dental Caries IncidenceBiannual assessment from enrollment to end of treatment (2.5 years)Number of teeth presenting with new caries
Caries PrevalenceBiannual assessment from enrollment to end of treatment (2.5 years)The prevalence of study participants with dental caries

Contacts

CONTACTRyan R Ruff, PhD, MPH
ryan.ruff@nyu.edu212-998-9663
PRINCIPAL_INVESTIGATORRyan R Ruff, PhD, MPH

New York University College of Dentistry/Epidemiology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026