Building Adaptive School-based Interventions for Caries (BASICS)
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Be enrolled in participating schools
- Be between the ages of 5 and 13 years
- Provide parental/guardian informed consent
- Child assent
Exclusion criteria
- Ulcerative gingivitis or stomatitis
- Known sensitivity to silver or other heavy-metal ions
- More than six affected sites
- Those who have had full mouth gingivectomies
- Patients showing abnormal skin sensitization in daily circumstances
- Those who have had pulp capping
Trial design
Primary purpose
Allocation
Interventional model
Masking
1,200 participants in 6 patient groups
Trial contacts and locations
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Central trial contact
Ryan R Ruff, PhD, MPH
Data sourced from clinicaltrials.gov
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