Comparative Effectiveness of School-based Caries Prevention

Not Applicable

Completed

Conditions: Quality of Life
Dental Caries

Interventions: Device: Fluoride Varnishes
Device: Silver Diamine Fluoride
Device: Glass Ionomer

Registration Number: NCT03442309

Lead Sponsor: NYU College of Dentistry

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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 7418

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Complex prevention	Fluoride Varnishes	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.
Complex prevention	Glass Ionomer	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.
Simple Prevention	Fluoride Varnishes	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.
Simple Prevention	Silver Diamine Fluoride	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.

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects With All Caries Arrested	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).
Prevalence of Dental Caries as Measured by a Clinical Oral Examination	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 Outcome Measures

Name	Time	Method
Oral Health-Related Quality of Life	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.
School Attendance	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.
Academic Performance	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.