An interventional study of Silver Diamine Fluoride and Fluoride Varnishes in Dental Caries, sponsored by NYU College of Dentistry. Completed at 1 site in United States. Open to participants aged 5 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-26.
Sponsored by NYU College of Dentistry · Not applicable, Interventional, and Prevention
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.
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.
1,138 studies on the registry are indexed under Dental Caries; 201 are open to participants now.
This study's enrollment of 3,345 is above the median of 60 across 936 interventional studies indexed under Dental Caries.
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Exclusion Criteria:
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 · Device: Fluoride Varnishes
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 · Device: Glass Ionomer
Silver diamine fluoride (SDF)
Also known as: Advantage Arrest
Fluoride varnish (FV)
Glass Ionomer Sealants (GC Fuji IX)
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
Time frame: 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
Time frame: Five years
| Milestone | Simple Prevention | Complex Prevention |
|---|---|---|
| Started | 1558 | 1787 |
| Completed | 1329 | 1529 |
| Not completed | 229 | 258 |
| Withdrew: Lost to follow-up | 229 | 258 |
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
| Participants | Simple Prevention | Complex Prevention |
|---|---|---|
| Number of Participants With Arrested Dental Caries, Assessed Using a Clinical Oral Examination | 48 | 53 |
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
| teeth | Simple Prevention | Complex Prevention |
|---|---|---|
| Caries Prevention | 210 | 179 |
Collected over Study participants were monitored for adverse events through study completion (5 years, 8 months; average per-participant duration 2.2 years).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Simple Prevention | 0/1,558 (0%) | 0/1,558 (0%) | 0/1,558 (0%) |
| Complex Prevention | 0/1,787 (0%) | 0/1,787 (0%) | 0/1,787 (0%) |
| Age, Continuous(years) | Simple Prevention | Complex Prevention | Total |
|---|---|---|---|
| Mean | 7.0 ± 1.8 | 7.3 ± 1.8 | 7.2 ± 1.8 |
| Sex: Female, Male(Participants) | Simple Prevention | Complex Prevention | Total |
|---|---|---|---|
| Female | 784 | 808 | 1592 |
| Male | 774 | 979 | 1753 |
| Race/Ethnicity, Customized(Participants) | Simple Prevention | Complex Prevention | Total |
|---|---|---|---|
| Hispanic/Latino | 13 | 23 | 36 |
| Black | 16 | 14 | 30 |
| White | 346 | 522 | 868 |
| Asian | 10 | 19 | 29 |
| Multiple | 10 | 9 | 19 |
| Other | 1 | 9 | 10 |
| Unreported | 1162 | 1191 | 2353 |
| Baseline untreated decay(Participants) | Simple Prevention | Complex Prevention | Total |
|---|---|---|---|
| Count of participants | 221 | 276 | 497 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data could be shared with proper approval from participating organizations for relevant and appropriate requests.
Supporting information: Study protocol, Informed consent form
Time frame: Data will be available December 1, 2025 and for five years.
Access criteria: By request of the original principal investigators.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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NYU College of Dentistry