Comparative Effectiveness of School-based Caries Prevention

Study Overview
=================
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.

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

Conditions
-----------------
Dental Caries, Quality of Life

Intervention / Treatment
-----------------
* Device: Silver Diamine Fluoride
* Device: Fluoride Varnishes
* Device: Glass Ionomer


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-arm, parallel, non-inferiority cluster randomized trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simple Prevention<br>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<br>* Silver diamine fluoride (SDF)<br>* Other names: Advantage Arrest;Device: Fluoride Varnishes<br>* Fluoride varnish (FV)<br>|
| Active Comparator: Complex prevention<br>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<br>* Fluoride varnish (FV)<br>Device: Glass Ionomer<br>* Glass Ionomer Sealants (GC Fuji IX)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arrest of dental caries as measured by clinical oral examination | For 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 treated (arrested) caries that stayed arrested | Two years | 
| Prevention of dental caries as measured by a clinical oral examination | For teeth without carious lesions (sound) treated with SDF/FV or Glass Ionomer/FV, what proportion of teeth stayed sound | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral Health-Related Quality of Life | Child oral health-related quality of life (e.g., functioning, social stigma, socio-emotional) as measured using the Child Oral Health Impact Profile - Short Form (COHIP-SF) | 5 years | 
| Student achievement on standardized math and English exams | Student achievement on math and English standardized examinations conducted from grades 3-8 given by the New York City Department of Education | 5 years | 
| School attendance | Annual school attendance per-participant as recorded by the New York City Department of Education | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
caries arrest, caries prevention, quality of life, silver diamine fluoride, dental caries, sealants, interim therapeutic restorations, student achievement, school attendance