Comparative Effectiveness of Treatments to Prevent Dental Caries
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|ClinicalTrials.gov Identifier: NCT03448107|
Recruitment Status : Active, not recruiting
First Posted : February 27, 2018
Last Update Posted : February 27, 2018
|Condition or disease||Intervention/treatment|
|Dental Caries||Device: Silver Diamine Fluoride Device: Fluoride Varnishes Device: Glass Ionomer|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3960 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two-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.|
|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 :||September 20, 2017|
|Estimated Primary Completion Date :||April 30, 2023|
|Estimated Study Completion Date :||April 30, 2023|
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 Name: Advantage ArrestDevice: 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)
- Arrest of dental caries assessed based on a clinical oral examination [ Time Frame: 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 [ Time Frame: Five years ]For teeth without carious lesions (sound teeth) treated with SDF/FV or Glass ionomer/FV, what proportion of teeth stayed sound
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448107
|United States, New York|
|New York University College of Dentistry|
|New York, New York, United States, 10010|
|Principal Investigator:||Richard Niederman, DMD||New York University School of Medicine|
|Principal Investigator:||Ryan R Ruff, MPH, PhD||New York University School of Medicine|