Comparative Effectiveness of School-based Caries Prevention

NCT03442309 | Completed Results FDA Device

• 1 other identifier: i17-00578
• Study Type: interventional
• Target: 7,418
• Locations: 1 country
• Sites: 1

Brief Summary

Dental caries (tooth decay) is the most prevalent childhood disease in the world. Multiple interventions are available to treat and prevent caries. The aim of the proposed study is to compare the benefit of silver diamine fluoride (SDF) and fluoride varnish versus fluoride varnish and glass ionomer sealants. This study is a five-year, cluster randomized, pragmatic controlled trial conducted in public elementary schools in New York City.

Conditions

Dental Caries; Quality of Life

Keywords

dental caries; caries arrest; caries prevention; quality of life; silver diamine fluoride; sealants; interim therapeutic restorations; student achievement; school attendance

Outcome Measures

Primary Outcomes (2)

• Proportion of Subjects With All Caries Arrested

  For any participants with any untreated dental caries on teeth at baseline treated with SDF/FV or Glass ionomer/FV to arrest (control) the infection, what is the proportion of subjects that stayed arrested. Differences were compared to the pre-established non-inferiority margin (10%). NOTE: this analysis conducted after COVID-19 suspensions, thus patient enrollment for this outcome is a subset of the total enrollment reported in Participant Flow. It reflects the total enrollment prior to COVID-19 suspensions (N=1398).

  Two years

• Prevalence of Dental Caries as Measured by a Clinical Oral Examination

  We assessed the prevalence of dental caries through up to four years of follow-up using generalized mixed effects models, with predictors included for time and treatment. Outcomes were assessed comparing the odds of dental caries in participants receiving the active control to those receiving the experimental condition and compared to the pre-established non-inferiority margin.

  Participants were evaluated biannually over a total of four years or until lost to follow-up, whichever occurred first.

Secondary Outcomes (3)

• Oral Health-Related Quality of Life

  Six months after initial treatment.

• School Attendance

  4 years after initial baseline observation

• Academic Performance

  4 years after initial baseline observation

Study Arms (2)

Simple Prevention

EXPERIMENTAL

One drop (0.05 ml) of silver diamine fluoride (Advantage ArrestTM) solution at 38% concentration (2.24 F-ion mg/dose) will be dispensed per child. Posterior tooth surfaces to be treated will be dried, after which the SDF will be applied with a micro-brush to all asymptomatic carious lesions and to all pits and fissures on bicuspids and molar teeth for thirty seconds. Fluoride varnishes (5% NaF) will then be applied to all teeth. Dosage frequency will be twice-yearly.

Device: Silver Diamine Fluoride; Device: Fluoride Varnishes

Complex prevention

ACTIVE COMPARATOR

Pits and fissures on all bicuspids and molar teeth will be sealed with glass ionomer sealants (GC Fuji IX). Glass ionomer sealants (interim therapeutic restorations) will also be placed on all frank asymptomatic carious lesions. Fluoride varnishes (5% NaF) will then be applied to all teeth. Dosage frequency will be twice-yearly.

Device: Fluoride Varnishes; Device: Glass Ionomer

Interventions

Silver Diamine Fluoride DEVICE

Silver diamine fluoride (SDF)

Also known as: Advantage Arrest

Simple Prevention

Fluoride Varnishes DEVICE

Fluoride varnish (FV)

Complex prevention; Simple Prevention

Glass Ionomer DEVICE

Glass Ionomer Sealants (GC Fuji IX)

Complex prevention

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Any primary school in New York City with a Hispanic/Latino student population greater than 50% and,
• A low-income population (defined as a student receiving free or reduced price lunch) of at least 80%.
• Within participating schools, all children are eligible to participate in the study.

You may not qualify if:

• Schools that already have a pre-existing school-based dental health program.

Sponsors & Collaborators

• NYU College of Dentistry: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Boston University: collaborator
• New York City Department of Health and Mental Hygiene: collaborator

Study Sites (1)

New York University College of Dentistry

New York, New York, 10010, United States

Location

Related Publications (5)

• Ruff RR, Gawande AA, Xu Q, Barry Godin T. Silver Diamine Fluoride vs Atraumatic Restoration for Managing Dental Caries in Schools: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2513826. doi: 10.1001/jamanetworkopen.2025.13826.

  PMID: 40489112 DERIVED

• Ruff RR, Barry Godin TJ, Niederman R. Noninferiority of Silver Diamine Fluoride vs Sealants for Reducing Dental Caries Prevalence and Incidence: A Randomized Clinical Trial. JAMA Pediatr. 2024 Apr 1;178(4):354-361. doi: 10.1001/jamapediatrics.2023.6770.

  PMID: 38436947 DERIVED

• Ruff RR, Habib R, Godin TB, Niederman R. School-based caries prevention and the impact on acute and chronic student absenteeism. J Am Dent Assoc. 2023 Aug;154(8):753-759. doi: 10.1016/j.adaj.2023.05.007.

  PMID: 37500236 DERIVED

• Ruff RR, Barry-Godin T, Niederman R. Effect of Silver Diamine Fluoride on Caries Arrest and Prevention: The CariedAway School-Based Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2255458. doi: 10.1001/jamanetworkopen.2022.55458.

  PMID: 36757696 DERIVED

• Ruff RR, Niederman R. Silver diamine fluoride versus therapeutic sealants for the arrest and prevention of dental caries in low-income minority children: study protocol for a cluster randomized controlled trial. Trials. 2018 Sep 26;19(1):523. doi: 10.1186/s13063-018-2891-1.

  PMID: 30257696 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Richard Niederman
• Organization: New York University

r.niederman@nyu.edu

917-280-5920

Study Officials

• Richard Niederman, DMD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Ryan R Ruff, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigators responsible for analyzing the data for primary outcomes will be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two-arm, parallel, non-inferiority cluster randomized trial

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 22, 2018
• Study Start: February 1, 2019
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: February 26, 2025
• Results First Posted: February 26, 2025

Record last verified: 2025-02

Locations

US (1)