Comparative Effectiveness of Treatments to Prevent Dental Caries

Sponsor

NYU College of Dentistry (Other)

Overall Status

Recruiting

CT.gov ID

NCT03448107

Collaborator

National Institute on Minority Health and Health Disparities (NIMHD) (NIH)

3,960

Enrollment

Location

Arms

67.3

Anticipated Duration (Months)

58.9

Patients Per Site Per Month

Study Details

Study Description

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 Hampshire.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Device: Silver Diamine Fluoride Device: Fluoride Varnishes Device: Glass Ionomer	N/A

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 children enrolled in public elementary schools in New Hampshire from 2017-2023. The primary objective is to assess the non-inferiority of alternative agents in the arrest and prevention of dental caries. Caries arrest will be evaluated after two years, and caries prevention 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

3960 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Prevention

Official Title:

Comparative Effectiveness of Treatments to Prevent Dental Caries Given to Rural Children in School-based Settings: Protocol for a Cluster Randomized Controlled Trial

Actual Study Start Date :

Sep 20, 2017

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Silver Diamine Fluoride Silver diamine fluoride (SDF) Other Names: Advantage Arrest Device: Fluoride Varnishes Fluoride varnish (FV)
Active Comparator: 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.	Device: Fluoride Varnishes Fluoride varnish (FV) Device: Glass Ionomer Glass Ionomer Sealants (GC Fuji IX)

Arm

Intervention/Treatment

Experimental: 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.

Device: Silver Diamine Fluoride

Silver diamine fluoride (SDF)

Other Names:

Advantage Arrest

Device: Fluoride Varnishes

Fluoride varnish (FV)

Active Comparator: 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.

Device: Fluoride Varnishes

Fluoride varnish (FV)

Device: Glass Ionomer

Glass Ionomer Sealants (GC Fuji IX)

Outcome Measures

Primary Outcome Measures

Arrest of dental caries assessed based on a clinical oral examination [Two years]
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
Caries prevention [Five years]
For teeth without carious lesions (sound teeth) treated with SDF/FV or Glass ionomer/FV, what proportion of teeth stayed sound

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Any primary school with a previously employed caries prevention program operating in rural areas, with official Title 1 status, and located in a health professional shortage area. Within participating schools, all children are eligible to participate in the study. Those with informed consent and assent will receive care.