Comparative Effectiveness of Treatments to Prevent Dental Caries

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Device: Silver Diamine Fluoride; Device: Fluoride Varnishes; Device: Glass Ionomer

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 Type: Interventional
• Enrollment (Actual): 3345
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • New York University College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Exclusion Criteria:

• Children without informed consent or those with consent but without assent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Arrested Dental Caries, Assessed Using a Clinical Oral Examination	For any participants with untreated dental caries on teeth at baseline treated with SDF/FV or Glass ionomer atraumatic restorative treatment (ART)/FV to arrest (control) the infection, what is the proportion of participants that stayed arrested	Two years
Caries Prevention	For teeth without carious lesions (sound teeth) treated with SDF/FV or Glass ionomer/FV, how many teeth developed caries over the course of observation	Five years

Collaborators and Investigators

• Sponsor: NYU College of Dentistry
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Ryan R Ruff, MPH, PhD, NYU Langone Health; Principal Investigator: Richard Niederman, DMD, NYU Langone Health

Publications and helpful links

General Publications

• Ruff RR, Niederman R. Comparative effectiveness of treatments to prevent dental caries given to rural children in school-based settings: protocol for a cluster randomised controlled trial. BMJ Open. 2018 Apr 13;8(4):e022646. doi: 10.1136/bmjopen-2018-022646.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2017
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: February 9, 2018
• First Submitted That Met QC Criteria: February 21, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: silver diamine fluoride; caries arrest; dental caries; caries prevention; sealants; interim therapeutic restorations
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Fluorides, Topical
• Other Study ID Numbers: i17-01221; R01MD011526 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data could be shared with proper approval from participating organizations for relevant and appropriate requests.
• IPD Sharing Time Frame: Data will be available December 1, 2025 and for five years.
• IPD Sharing Access Criteria: By request of the original principal investigators.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No