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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 : September 30, 2022
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

Tracking Information
First Submitted Date  ICMJE February 9, 2018
First Posted Date  ICMJE February 22, 2018
Last Update Posted Date September 30, 2022
Actual Study Start Date  ICMJE February 1, 2019
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
  • 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)
  • 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
  • School attendance [ Time Frame: 5 years ]
    Annual school attendance per-participant as recorded by the New York City Department of Education
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Effectiveness of School-based Caries Prevention
Official Title  ICMJE Silver Diamine Fluoride Versus Therapeutic Sealants for the Arrest and Prevention of Dental Caries in Low-income Minority Children
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Dental Caries
  • Quality of Life
Intervention  ICMJE
  • Device: Silver Diamine Fluoride
    Silver diamine fluoride (SDF)
    Other Name: Advantage Arrest
  • Device: Fluoride Varnishes
    Fluoride varnish (FV)
  • Device: Glass Ionomer
    Glass Ionomer Sealants (GC Fuji IX)
Study Arms  ICMJE
  • 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.

    Interventions:
    • Device: Silver Diamine Fluoride
    • Device: Fluoride Varnishes
  • 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.

    Interventions:
    • Device: Fluoride Varnishes
    • Device: Glass Ionomer
Publications * Ruff RR, Niederman R. Silver diamine fluoride versus therapeutic sealants for the arrest and prevention of dental caries in low-income minority children: study protocol for a cluster randomized controlled trial. Trials. 2018 Sep 26;19(1):523. doi: 10.1186/s13063-018-2891-1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 15, 2018)		 14100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Richard Niederman, DMD 212-998-9719 rniederman@nyu.edu
Contact: Ryan R Ruff, PhD 212-998-9663 ryan.ruff@nyu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03442309
Other Study ID Numbers  ICMJE i17-00578
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Individual participant data could be shared with proper approval from participating organizations for relevant and appropriate requests.
Current Responsible Party Richard Niederman, NYU College of Dentistry
Original Responsible Party Same as current
Current Study Sponsor  ICMJE NYU College of Dentistry
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Patient-Centered Outcomes Research Institute
  • Boston University
  • New York City Department of Health and Mental Hygiene
Investigators  ICMJE
Principal Investigator: Richard Niederman, DMD NYU Langone Health
Principal Investigator: Ryan R Ruff, PhD NYU Langone Health
PRS Account NYU College of Dentistry
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP