Comparative Effectiveness of School-based Caries Prevention

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7418 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2023-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Dental Caries Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-arm, parallel, non-inferiority cluster randomized trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

The investigators responsible for analyzing the data for primary outcomes will be masked.

Study Groups

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Simple Prevention

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.

Group Type EXPERIMENTAL

Silver Diamine Fluoride

Intervention Type DEVICE

Silver diamine fluoride (SDF)

Fluoride Varnishes

Intervention Type DEVICE

Fluoride varnish (FV)

Complex prevention

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.

Group Type ACTIVE_COMPARATOR

Fluoride Varnishes

Intervention Type DEVICE

Fluoride varnish (FV)

Glass Ionomer

Intervention Type DEVICE

Glass Ionomer Sealants (GC Fuji IX)

Interventions

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Silver Diamine Fluoride

Silver diamine fluoride (SDF)

Intervention Type DEVICE

Fluoride Varnishes

Fluoride varnish (FV)

Intervention Type DEVICE

Glass Ionomer

Glass Ionomer Sealants (GC Fuji IX)

Intervention Type DEVICE

Other Intervention Names

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Advantage Arrest

Eligibility Criteria

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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.