ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 51 for:    tooth decay | NIH
Previous Study | Return to List | Next Study

Comparative Effectiveness of Treatments to Prevent Dental Caries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03448107
Recruitment Status : Active, not recruiting
First Posted : February 27, 2018
Last Update Posted : February 27, 2018
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Richard Niederman, NYU College of Dentistry

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 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 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
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: 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

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)




Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 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.

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): NCT03448107


Locations
United States, New York
New York University College of Dentistry
New York, New York, United States, 10010
Sponsors and Collaborators
NYU College of Dentistry
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Principal Investigator: Richard Niederman, DMD New York University School of Medicine
Principal Investigator: Ryan R Ruff, MPH, PhD New York University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Richard Niederman, Professor, NYU College of Dentistry
ClinicalTrials.gov Identifier: NCT03448107     History of Changes
Other Study ID Numbers: i17-01221
R01MD011526 ( U.S. NIH Grant/Contract )
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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
silver diamine fluoride
sealants
interim therapeutic restorations

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs