Building Adaptive School-based Interventions for Caries

Part of paid clinical trials in Glenwood Springs, Colorado.

Sponsor
University of Pennsylvania
Study ID
NCT07265830
Phase
PHASE3
Status
Recruiting
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Conditions

  • Dental Caries

Eligibility Criteria

Sex
ALL
Age
5 Years - 13 Years
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Dec 5, 2025
Start date
Aug 18, 2026
Status verified
Sep 2026
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
1,200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Subgroup A, SDF only
    Single intervention: Silver diamine fluoride (SDF)
  • Active Comparator: Subgroup D, Sealant only
    Single intervention: Glass Ionomer Cement (GIC) Sealant
  • Experimental: Subgroup B, SDF + FV + Hygiene Intervention
    Nonresponse arm: SDF (First stage) + \[SDF + Fluoride Varnish (FV) + Hygiene Intervention (Second Stage)\]
  • Experimental: Subgroup C, SDF + SMART + Sealant
    Nonresponse arm: SDF (First Stage) + \[Silver Modified Atraumatic Restorative Treatment (SMART) + Sealant (Second Stage)\]
  • Experimental: Subgroup E, Sealant + SMART + FV + Hygiene Intervention
    Nonresponse arm: GIC Sealant (First Stage) + \[ART + FV + Hygiene Intervention (Second Stage)\]
  • Experimental: Subgroup F, Sealant + SMART
    Nonresponse arm: GIC Sealant (First Stage) + \[SMART (Second Stage)\]

Primary Outcome Measure

Dental Caries Incidence [ Time Frame: Biannual assessment from enrollment to end of treatment (2.5 years) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Smiles For StudentsGlenwood SpringsColorado81601-

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Smiles For Students· Glenwood Springs, CO

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