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NCT Number: NCT07265830

Building Adaptive School-based Interventions for Caries

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.

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Key information

Age range

5 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silver Diamine Fluoride (38%)

Device

Topically applied silver diamine fluoride 38% solution

Glass Ionomer Sealant

Device

GIC Dental Sealants

Fluoride Varnishes

Device

Topically applied fluoride varnish (FV)

Hygiene Intervention

Behavioral

Behavioral intervention to improve dental hygiene

Primary outcomes

  1. Dental Caries Incidence

    Time frame: Biannual assessment from enrollment to end of treatment (2.5 years)

    Number of teeth presenting with new caries

  2. Caries Prevalence

    Time frame: Biannual assessment from enrollment to end of treatment (2.5 years)

    The prevalence of study participants with dental caries

Study contacts

Contact information is provided by the study sponsor or research team.

Ryan R Ruff, PhD, MPH

CONTACT

[email protected]

212-998-9663

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study 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

Acronym: BASICS

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Dec 5, 2025
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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