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Comparative Effectiveness of School-based Caries Prevention

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ClinicalTrials.gov Identifier: NCT03442309
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : October 8, 2020
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Boston University
New York City Department of Health and Mental Hygiene
Information provided by (Responsible Party):
Richard Niederman, NYU College of Dentistry

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dental Caries Quality of Life Device: Silver Diamine Fluoride Device: Fluoride Varnishes Device: Glass Ionomer Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14100 participants
Allocation: Randomized
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.
Primary Purpose: Prevention
Official Title: Silver Diamine Fluoride Versus Therapeutic Sealants for the Arrest and Prevention of Dental Caries in Low-income Minority Children
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. Arrest of dental caries as measured by 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

  2. Prevention of dental caries as measured by a clinical oral examination [ Time Frame: 5 years ]
    For teeth without carious lesions (sound) treated with SDF/FV or Glass Ionomer/FV, what proportion of teeth stayed sound


Secondary Outcome Measures :
  1. Oral Health-Related Quality of Life [ Time Frame: 5 years ]
    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)

  2. Student achievement on standardized math and English exams [ Time Frame: 5 years ]
    Student achievement on math and English standardized examinations conducted from grades 3-8 given by the New York City Department of Education

  3. School attendance [ Time Frame: 5 years ]
    Annual school attendance per-participant as recorded by the New York City Department of Education


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03442309


Contacts
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Contact: Richard Niederman, DMD 212-998-9719 rniederman@nyu.edu
Contact: Ryan R Ruff, PhD 212-998-9663 ryan.ruff@nyu.edu

Locations
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United States, New York
New York University College of Dentistry Recruiting
New York, New York, United States, 10010
Contact: Richard Niederman, DMD    212-998-9719    rniederman@nyu.edu   
Contact: Ryan R Ruff, MPH, PhD    212-998-9663    ryan.ruff@nyu.edu   
Sponsors and Collaborators
NYU College of Dentistry
Patient-Centered Outcomes Research Institute
Boston University
New York City Department of Health and Mental Hygiene
Investigators
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Principal Investigator: Richard Niederman, DMD NYU Langone Health
Principal Investigator: Ryan R Ruff, PhD NYU Langone Health
  Study Documents (Full-Text)

Documents provided by Richard Niederman, NYU College of Dentistry:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Protocol and Analysis Plan  [PDF] December 8, 2017
Informed Consent Form: Recruitment and Informed Consent  [PDF] February 15, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Richard Niederman, Professor, NYU College of Dentistry
ClinicalTrials.gov Identifier: NCT03442309    
Other Study ID Numbers: i17-00578
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Individual participant data could be shared with proper approval from participating organizations for relevant and appropriate requests.

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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
Keywords provided by Richard Niederman, NYU College of Dentistry:
dental caries
caries arrest
caries prevention
quality of life
silver diamine fluoride
 sealants
interim therapeutic restorations
student achievement
school attendance
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
 Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs