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Background <p>School-based caries prevention programs are clinically and cost-effective public health approaches to increase access to essential oral healthcare for high-risk children. However, approximately 1 in 4 children participating in school caries prevention fail to respond to care, remaining at risk for dental caries and related sequela.</p> Methods <p>The Building Adaptive School-based Interventions for Caries study (BASICS) will develop and test adaptive preventive interventions using a Sequential, Multiple Assignment, Randomized Trial (SMART) design, reducing treatment nonresponse by incorporating personalized medicine into school caries prevention. Children will receive a first-stage treatment of either silver diamine fluoride or glass ionomer dental sealants and atraumatic restorations. At subsequent observations, the primary outcome of reoccurrence or new presentation of dental caries will be used as a tailoring variable for treatment nonresponse. Nonresponsive participants in either first-stage pathway will subsequently receive either (1) reapplication of initial treatment plus fluoride varnish and receipt of an electronic toothbrush or (2) an intensified Silver Modified Atraumatic Restorative Technique. The targeted enrollment is 1200 children from primarily low-income rural families enrolled in kindergarten through third grades in public primary schools.</p> Discussion <p>Primary study objectives of BASICS include determining the most effective initial treatment for caries prevention and sequence of treatments to reduce nonresponse, identifying the optimal dynamic treatment regime given patient attributes, and estimating the most cost-efficient allocation of resources for adaptive school-based caries prevention. If successful, BASICS will result in a resource-efficient approach to school dental care that optimizes resources matched to patient needs.</p> Trial registration <p>ClinicalTrials.gov #NCT07265830, Registered on 12/4/25.</p> <p><a href="https://www.clinicaltrials.gov/study/NCT07265830">https://www.clinicaltrials.gov/study/NCT07265830</a></p>

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Building Adaptive School-Based Interventions for Caries (BASICS): study protocol for a Sequential, Multiple Assignment, Randomized Trial

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年3月4日

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  • Ryan Richard Ruff,
  • Tamarinda Barry Godín,
  • Shulamite Huang

摘要

Background

School-based caries prevention programs are clinically and cost-effective public health approaches to increase access to essential oral healthcare for high-risk children. However, approximately 1 in 4 children participating in school caries prevention fail to respond to care, remaining at risk for dental caries and related sequela.

Methods

The Building Adaptive School-based Interventions for Caries study (BASICS) will develop and test adaptive preventive interventions using a Sequential, Multiple Assignment, Randomized Trial (SMART) design, reducing treatment nonresponse by incorporating personalized medicine into school caries prevention. Children will receive a first-stage treatment of either silver diamine fluoride or glass ionomer dental sealants and atraumatic restorations. At subsequent observations, the primary outcome of reoccurrence or new presentation of dental caries will be used as a tailoring variable for treatment nonresponse. Nonresponsive participants in either first-stage pathway will subsequently receive either (1) reapplication of initial treatment plus fluoride varnish and receipt of an electronic toothbrush or (2) an intensified Silver Modified Atraumatic Restorative Technique. The targeted enrollment is 1200 children from primarily low-income rural families enrolled in kindergarten through third grades in public primary schools.

Discussion

Primary study objectives of BASICS include determining the most effective initial treatment for caries prevention and sequence of treatments to reduce nonresponse, identifying the optimal dynamic treatment regime given patient attributes, and estimating the most cost-efficient allocation of resources for adaptive school-based caries prevention. If successful, BASICS will result in a resource-efficient approach to school dental care that optimizes resources matched to patient needs.

Trial registration

ClinicalTrials.gov #NCT07265830, Registered on 12/4/25.

https://www.clinicaltrials.gov/study/NCT07265830