Building Adaptive School-based Interventions for Caries

NCT07265830 | Not Yet Recruiting Phase 3 FDA Device

• 2 other identifiers: i24-01908R01MD019938
• Study Type: interventional
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Dental Caries Incidence

  Number of teeth presenting with new caries

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

• Caries Prevalence

  The prevalence of study participants with dental caries

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

Study Arms (6)

Subgroup A, SDF only

EXPERIMENTAL

Single intervention: Silver diamine fluoride (SDF)

Device: Silver Diamine Fluoride (38%)

Subgroup D, Sealant only

ACTIVE COMPARATOR

Single intervention: Glass Ionomer Cement (GIC) Sealant

Device: Glass Ionomer Sealant

Subgroup B, SDF + FV + Hygiene Intervention

EXPERIMENTAL

Nonresponse arm: SDF (First stage) + \[SDF + Fluoride Varnish (FV) + Hygiene Intervention (Second Stage)\]

Device: Silver Diamine Fluoride (38%); Device: Fluoride Varnishes; Behavioral: Hygiene Intervention

Subgroup C, SDF + SMART + Sealant

EXPERIMENTAL

Nonresponse arm: SDF (First Stage) + \[Silver Modified Atraumatic Restorative Treatment (SMART) + Sealant (Second Stage)\]

Device: Silver Diamine Fluoride (38%); Device: Glass Ionomer Sealant

Subgroup E, Sealant + SMART + FV + Hygiene Intervention

EXPERIMENTAL

Nonresponse arm: GIC Sealant (First Stage) + \[ART + FV + Hygiene Intervention (Second Stage)\]

Device: Glass Ionomer Sealant; Device: Fluoride Varnishes; Behavioral: Hygiene Intervention

Subgroup F, Sealant + SMART

EXPERIMENTAL

Nonresponse arm: GIC Sealant (First Stage) + \[SMART (Second Stage)\]

Device: Silver Diamine Fluoride (38%); Device: Glass Ionomer Sealant

Interventions

Glass Ionomer Sealant DEVICE

GIC Dental Sealants

Subgroup C, SDF + SMART + Sealant; Subgroup D, Sealant only; Subgroup E, Sealant + SMART + FV + Hygiene Intervention; Subgroup F, Sealant + SMART

Fluoride Varnishes DEVICE

Topically applied fluoride varnish (FV)

Subgroup B, SDF + FV + Hygiene Intervention; Subgroup E, Sealant + SMART + FV + Hygiene Intervention

Hygiene Intervention BEHAVIORAL

Behavioral intervention to improve dental hygiene

Subgroup B, SDF + FV + Hygiene Intervention; Subgroup E, Sealant + SMART + FV + Hygiene Intervention

Silver Diamine Fluoride (38%) DEVICE

Topically applied silver diamine fluoride 38% solution

Subgroup A, SDF only; Subgroup B, SDF + FV + Hygiene Intervention; Subgroup C, SDF + SMART + Sealant; Subgroup F, Sealant + SMART

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Be enrolled in participating schools
• Be between the ages of 5 and 13 years
• Provide parental/guardian informed consent
• Child assent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Related Publications (1)

• Ruff RR, Godin TB, Huang S. Building Adaptive School-Based Interventions for Caries (BASICS): study protocol for a Sequential, Multiple Assignment, Randomized Trial. Trials. 2026 Mar 4. doi: 10.1186/s13063-026-09588-5. Online ahead of print.

  PMID: 41776554 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Ryan R Ruff, PhD, MPH

  New York University College of Dentistry/Epidemiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan R Ruff, PhD, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: BASICS is a phase-III Sequential, Multiple-Assignment, Randomized Trial (SMART)

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 5, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD and supporting information will be available at the end of the trial for five years.
• Access Criteria: Anyone with an approved data use agreement.