Comparative Effectiveness of Treatments to Prevent Dental Caries
2 other identifiers
interventional
3,345
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 20, 2017
CompletedFirst Submitted
Initial submission to the registry
February 9, 2018
CompletedFirst Posted
Study publicly available on registry
February 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedResults Posted
Study results publicly available
February 26, 2025
CompletedFebruary 26, 2025
February 1, 2025
5.8 years
February 9, 2018
November 13, 2024
February 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Simple Prevention
EXPERIMENTALOne 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.
Complex Prevention
ACTIVE COMPARATORPits 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
Silver diamine fluoride (SDF)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Children without informed consent or those with consent but without assent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University College of Dentistry
New York, New York, 10010, United States
Related Publications (2)
Ruff RR, Niederman R. School-based caries prevention using silver diamine fluoride: A pragmatic randomized trial in low-income rural children. medRxiv [Preprint]. 2024 Jun 25:2024.06.05.24308499. doi: 10.1101/2024.06.05.24308499.
PMID: 38883737DERIVEDRuff 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.
PMID: 29654053DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Richard Niederman
- Organization
- NYU Dentistry
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Niederman, DMD
NYU Langone Health
- PRINCIPAL INVESTIGATOR
Ryan R Ruff, MPH, PhD
NYU Langone Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The investigators responsible for analyzing the data for primary outcomes will be masked.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 9, 2018
First Posted
February 27, 2018
Study Start
September 20, 2017
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
February 26, 2025
Results First Posted
February 26, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will be available December 1, 2025 and for five years.
- Access Criteria
- By request of the original principal investigators.
Individual participant data could be shared with proper approval from participating organizations for relevant and appropriate requests.