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Completed

NCT Number: NCT03442309

Comparative Effectiveness of School-based Caries Prevention

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.

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Key information

Conditions

Dental Caries Quality of Life Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University College of Dentistry

New York, 10010, United States

About this study

Dental caries is the most prevalent childhood disease in the world and can lead to infection, pain, reduced quality of life, and negative educational outcomes. Multiple prevention agents are available to arrest and prevent dental caries, however little is known of the comparative effectiveness of combined treatments in pragmatic settings. The aim of the presented study is to compare the benefit of silver diamine fluoride and fluoride varnish versus fluoride varnish and glass ionomer therapeutic sealants in the arrest and prevention of dental caries.

This is a longitudinal, pragmatic, cluster randomized, single-blind, non-inferiority trial to be conducted in low-income minority children enrolled in public elementary schools in New York City, New York, United States, from 2018-2023. The primary objective is to assess the non-inferiority of alternative agents in the arrest and prevention of dental caries. Secondary objectives are to assess oral health-related quality of life and educational outcomes. Caries arrest will be evaluated after two years, and caries prevention and secondary outcomes will be assessed at the completion of the study. Data analysis will follow intent to treat, and statistical analyses will be conducted using a two-sided significance level of 0.05.

Notably, the standard of care for dental caries is office-based surgery, which presents multiple barriers to care including cost, fear, and geographic isolation. The simplicity and affordability of silver diamine fluoride may be a viable alternative for the arrest and prevention of dental caries in high-risk children.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Schools that already have a pre-existing school-based dental health program.
  • Within participating schools, exclusion criteria for children include those without informed consent or those with consent but without assent.

Treatment and study plan

Silver diamine fluoride

Device

Silver diamine fluoride (SDF)

Other names: Advantage Arrest

Fluoride Varnishes

Device

Fluoride varnish (FV)

Glass ionomer

Device

Glass Ionomer Sealants (GC Fuji IX)

Primary outcomes

  1. Proportion of Subjects With All Caries Arrested

    Time frame: Two years

    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).

  2. Prevalence of Dental Caries as Measured by a Clinical Oral Examination

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

    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.

Secondary outcomes

  1. Oral Health-Related Quality of Life

    Time frame: Six months after initial treatment.

    A subset of participants in each treatment group were randomly selected to complete an oral health-related quality of life (OHRQoL) instrument (name: Child Oral Health Impact Profile - Short Form, COHIP-SF19) to compare quality of life pre/post treatment and between treatment groups. Here the differences in COHIP-SF scales are reported six months after initial treatment. After this, COVID-19 suspensions removed any further follow-up for this outcome, which is also why the same sizes are not the same for the full trial. In this analysis, higher scores indicate worse OHRQoL.

    The COHIP-SF scale consists of 19 items. Each item on the scale was scored between 0-3, for a total scale range of 0 to 57.

  2. School Attendance

    Time frame: 4 years after initial baseline observation

    Annual school attendance (chronic absenteeism) at the school level as recorded by the New York City Department of Education. In evaluating this outcome, we assessed school-level data on the proportion of students who were absent. Additionally, we obtained data from an additional 15 schools which met inclusion criteria but did not participate in the trial as a non-randomized comparison group. This allowed us to compare schools in the experimental group to those in the active control, as well as to a non-randomized untreated group of schools.

  3. Academic Performance

    Time frame: 4 years after initial baseline observation

    Children participating in schools assigned to each arm of the trial that received care were to have their academic performance evaluated. This outcome was to use academic performance data collected by the school, not investigators.

Sponsors and collaborators

Lead sponsor

NYU College of Dentistry

Other

Collaborators

  • Boston University
  • New York City Department of Health and Mental Hygiene
  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Silver Diamine Fluoride Versus Therapeutic Sealants for the Arrest and Prevention of Dental Caries in Low-income Minority Children

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 22, 2018
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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