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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD011526 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simple Prevention | Experimental | 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. |
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| Complex Prevention | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silver Diamine Fluoride | Device | Silver diamine fluoride (SDF) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Niederman, DMD | NYU Langone Health | Principal Investigator |
| Ryan R Ruff, MPH, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University College of Dentistry | New York | New York | 10010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38883737 | Derived | 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. | |
| 29654053 | Derived | Ruff 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. |
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Individual participant data could be shared with proper approval from participating organizations for relevant and appropriate requests.
Data will be available December 1, 2025 and for five years.
By request of the original principal investigators.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Silver Diamine Fluoride: Silver diamine fluoride (SDF) Fluoride Varnishes: Fluoride varnish (FV) |
| FG001 | 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/atraumatic 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. Fluoride Varnishes: Fluoride varnish (FV) Glass Ionomer: Glass Ionomer Sealants (GC Fuji IX) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Silver Diamine Fluoride: Silver diamine fluoride (SDF) Fluoride Varnishes: Fluoride varnish (FV) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The analysis population are those participants who completed the study and had dental caries at baseline. This population is a subset of the full study population. | Posted | Count of Participants | Participants | Two years |
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Study participants were monitored for adverse events through study completion (5 years, 8 months; average per-participant duration 2.2 years).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Silver Diamine Fluoride: Silver diamine fluoride (SDF) Fluoride Varnishes: Fluoride varnish (FV) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Niederman | NYU Dentistry | 917-280-5920 | r.niederman@nyu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 8, 2021 | Dec 4, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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Two-arm, parallel, non-inferiority cluster randomized trial
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The investigators responsible for analyzing the data for primary outcomes will be masked.
| Fluoride Varnishes | Device | Fluoride varnish (FV) |
|
| Glass Ionomer | Device | Glass Ionomer Sealants (GC Fuji IX) |
|
| BG001 | 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/atraumatic 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. Fluoride Varnishes: Fluoride varnish (FV) Glass Ionomer: Glass Ionomer Sealants (GC Fuji IX) |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Baseline untreated decay | Count of Participants | Participants |
|
| OG001 | 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/atraumatic 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. Fluoride Varnishes: Fluoride varnish (FV) Glass Ionomer: Glass Ionomer Sealants (GC Fuji IX) |
|
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| Primary | 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 | The analysis population includes the total number of teeth in each participant in each group. Thus, the overall number of units analyzed will be greater than the number in participant flow (participant flow reflects individuals participating in the study). | Posted | Number | teeth | Five years | Teeth | Teeth |
|
|
|
| 0 |
| 1,558 |
| 0 |
| 1,558 |
| 0 |
| 1,558 |
| EG001 | 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/atraumatic 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. Fluoride Varnishes: Fluoride varnish (FV) Glass Ionomer: Glass Ionomer Sealants (GC Fuji IX) | 0 | 1,787 | 0 | 1,787 | 0 | 1,787 |
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