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

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) |
- 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
- 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

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Ages Eligible for Study: | 5 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
Contact: Richard Niederman, DMD | 212-998-9719 | rniederman@nyu.edu | |
Contact: Ryan R Ruff, PhD | 212-998-9663 | ryan.ruff@nyu.edu |
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 |
Principal Investigator: | Richard Niederman, DMD | NYU Langone Health | |
Principal Investigator: | Ryan R Ruff, PhD | NYU Langone Health |
Documents provided by Richard Niederman, NYU College of Dentistry:
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: | September 30, 2022 |
Last Verified: | September 2022 |
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 |
Product Manufactured in and Exported from the U.S.: | No |
dental caries caries arrest caries prevention quality of life silver diamine fluoride |
sealants interim therapeutic restorations student achievement school attendance |
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases Fluorides |
Fluorides, Topical Cariostatic Agents Protective Agents Physiological Effects of Drugs |