Recruiting
Phase 3

Adaptive Interventions

Sponsor:

University of Pennsylvania

Code:

NCT07265830

Conditions

Dental Caries

Eligibility Criteria

Sex: All

Age: 5 - 13

Healthy Volunteers: Accepted

Interventions

Silver Diamine Fluoride (38%)

Glass Ionomer Sealant

Fluoride Varnishes

Hygiene Intervention

Study Details

Brief summary:

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.

Conditions

Dental Caries

Study ID

NCT07265830

Start date

Aug 18, 2026

Status verified date

Sep, 2026

Completion date

Jun, 2030

Anticipated

Primary completion date

Jun, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 13

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Be enrolled in participating schools
2. Be between the ages of 5 and 13 years
3. Provide parental/guardian informed consent
4. Child assent

Exclusion Criteria:

1. Ulcerative gingivitis or stomatitis
2. Known sensitivity to silver or other heavy-metal ions
3. More than six affected sites
4. Those who have had full mouth gingivectomies
5. Patients showing abnormal skin sensitization in daily circumstances
6. Those who have had pulp capping

Study Design

Enrollment

1200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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) + \[SMART (Second Stage)\]

Interventions

Silver Diamine Fluoride (38%)

Topically applied silver diamine fluoride 38% solution

Glass Ionomer Sealant

GIC Dental Sealants

Fluoride Varnishes

Topically applied fluoride varnish (FV)

Hygiene Intervention

Behavioral intervention to improve dental hygiene

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ryan R Ruff, PhD, MPH

212-998-9663ryan.ruff@nyu.edu

Locations

Smiles For Students

Recruiting

Glenwood Springs, Colorado, United States, 81601

More Information

Sponsor

University of Pennsylvania

Last update posted

Sep 10, 2026

Last verified

Sep, 2026

Keywords

  • Dental caries
  • Adaptive interventions
  • Prevention
  • Child
  • Dynamic treatment regimes
  • SMART

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-09-10.