Trials · 2026
Building Adaptive School-Based Interventions for Caries (BASICS): study protocol for a Sequential, Multiple Assignment, Randomized Trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Ruff Ryan Richard, Godín Tamarinda Barry, Huang Shulamite
Аннотация
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.
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.
Предметные рубрики MeSH
HumansDental CariesChildSchool DentistryFluorides, TopicalDental Atraumatic Restorative TreatmentRandomized Controlled Trials as TopicPit and Fissure SealantsTreatment OutcomeTime FactorsCariostatic AgentsQuaternary Ammonium CompoundsSilver CompoundsFluoride TreatmentSchool Health ServicesGlass Ionomer CementsAdaptive Clinical Trials as TopicChild, PreschoolPrecision Medicine