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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| Boston University | OTHER |
| New York City Department of Health and Mental Hygiene | OTHER_GOV |
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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 York City.
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.
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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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silver Diamine Fluoride | Device | Silver diamine fluoride (SDF) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With All Caries Arrested | For any participants with 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 subjects that stayed arrested. Differences were compared to the pre-established non-inferiority margin (10%). NOTE: this analysis conducted after COVID-19 suspensions, thus patient enrollment for this outcome is a subset of the total enrollment reported in Participant Flow. It reflects the total enrollment prior to COVID-19 suspensions (N=1398). | Two years |
| Prevalence of Dental Caries as Measured by a Clinical Oral Examination | We assessed the prevalence of dental caries through up to four years of follow-up using generalized mixed effects models, with predictors included for time and treatment. Outcomes were assessed comparing the odds of dental caries in participants receiving the active control to those receiving the experimental condition and compared to the pre-established non-inferiority margin. | Participants were evaluated biannually over a total of four years or until lost to follow-up, whichever occurred first. |
| Measure | Description | Time Frame |
|---|---|---|
| Oral Health-Related Quality of Life | A subset of participants in each treatment group were randomly selected to complete an oral health-related quality of life (OHRQoL) instrument (name: Child Oral Health Impact Profile - Short Form, COHIP-SF19) to compare quality of life pre/post treatment and between treatment groups. Here the differences in COHIP-SF scales are reported six months after initial treatment. After this, COVID-19 suspensions removed any further follow-up for this outcome, which is also why the same sizes are not the same for the full trial. In this analysis, higher scores indicate worse OHRQoL. The COHIP-SF scale consists of 19 items. Each item on the scale was scored between 0-3, for a total scale range of 0 to 57. |
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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, 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 |
|---|---|---|---|
| 40489112 | Derived | Ruff RR, Gawande AA, Xu Q, Barry Godin T. Silver Diamine Fluoride vs Atraumatic Restoration for Managing Dental Caries in Schools: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2513826. doi: 10.1001/jamanetworkopen.2025.13826. | |
| 38436947 | Derived | Ruff RR, Barry Godin TJ, Niederman R. Noninferiority of Silver Diamine Fluoride vs Sealants for Reducing Dental Caries Prevalence and Incidence: A Randomized Clinical Trial. JAMA Pediatr. 2024 Apr 1;178(4):354-361. doi: 10.1001/jamapediatrics.2023.6770. |
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Individual participant data could be shared with proper approval from participating organizations for relevant and appropriate requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Condition | 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 | Active Control | Pits and fissures on all bicuspids and molar teeth will be sealed with glass ionomer sealants (GC Fuji IX). Glass ionomer sealants (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) and atraumatic restorations |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Condition | 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 |
|
| 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 | Proportion of Subjects With All Caries Arrested | For any participants with 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 subjects that stayed arrested. Differences were compared to the pre-established non-inferiority margin (10%). NOTE: this analysis conducted after COVID-19 suspensions, thus patient enrollment for this outcome is a subset of the total enrollment reported in Participant Flow. It reflects the total enrollment prior to COVID-19 suspensions (N=1398). | The study was suspended after initial enrollment and treatment in response to COVID-19. The number of subjects for this outcome subsequently reflects only those enrolled before COVID-19 suspensions and successfully completed a follow-up procedure two years later. | Posted | Count of Participants | Participants | Two years |
|
Maximum of 4 years of follow-up observation, post-baseline
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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 | Experimental Condition | 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 | New York University | 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 | Jul 27, 2022 | Nov 13, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Recruitment and Informed Consent | Feb 15, 2018 | Feb 15, 2018 | ICF_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) |
|
| Six months after initial treatment. |
| School Attendance | Annual school attendance (chronic absenteeism) at the school level as recorded by the New York City Department of Education. In evaluating this outcome, we assessed school-level data on the proportion of students who were absent. Additionally, we obtained data from an additional 15 schools which met inclusion criteria but did not participate in the trial as a non-randomized comparison group. This allowed us to compare schools in the experimental group to those in the active control, as well as to a non-randomized untreated group of schools. | 4 years after initial baseline observation |
| Academic Performance | Children participating in schools assigned to each arm of the trial that received care were to have their academic performance evaluated. This outcome was to use academic performance data collected by the school, not investigators. | 4 years after initial baseline observation |
| 37500236 | Derived | Ruff RR, Habib R, Godin TB, Niederman R. School-based caries prevention and the impact on acute and chronic student absenteeism. J Am Dent Assoc. 2023 Aug;154(8):753-759. doi: 10.1016/j.adaj.2023.05.007. |
| 36757696 | Derived | Ruff RR, Barry-Godin T, Niederman R. Effect of Silver Diamine Fluoride on Caries Arrest and Prevention: The CariedAway School-Based Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2255458. doi: 10.1001/jamanetworkopen.2022.55458. |
| 30257696 | Derived | Ruff RR, Niederman R. Silver diamine fluoride versus therapeutic sealants for the arrest and prevention of dental caries in low-income minority children: study protocol for a cluster randomized controlled trial. Trials. 2018 Sep 26;19(1):523. doi: 10.1186/s13063-018-2891-1. |
| BG001 | Active Control | Pits and fissures on all bicuspids and molar teeth will be sealed with glass ionomer sealants (GC Fuji IX). Glass ionomer sealants (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) and atraumatic restorations |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Number of participants with untreated tooth decay | Any instance of tooth decay regardless of severity or number of teeth affected | Count of Participants | Participants |
|
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)
| OG001 | Active Control | Pits and fissures on all bicuspids and molar teeth will be sealed with glass ionomer sealants (GC Fuji IX). Glass ionomer sealants (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) and atraumatic restorations |
|
|
|
| Primary | Prevalence of Dental Caries as Measured by a Clinical Oral Examination | We assessed the prevalence of dental caries through up to four years of follow-up using generalized mixed effects models, with predictors included for time and treatment. Outcomes were assessed comparing the odds of dental caries in participants receiving the active control to those receiving the experimental condition and compared to the pre-established non-inferiority margin. | Posted | Number | # of caries per 1000 tooth years | Participants were evaluated biannually over a total of four years or until lost to follow-up, whichever occurred first. |
|
|
|
|
| Secondary | Oral Health-Related Quality of Life | A subset of participants in each treatment group were randomly selected to complete an oral health-related quality of life (OHRQoL) instrument (name: Child Oral Health Impact Profile - Short Form, COHIP-SF19) to compare quality of life pre/post treatment and between treatment groups. Here the differences in COHIP-SF scales are reported six months after initial treatment. After this, COVID-19 suspensions removed any further follow-up for this outcome, which is also why the same sizes are not the same for the full trial. In this analysis, higher scores indicate worse OHRQoL. The COHIP-SF scale consists of 19 items. Each item on the scale was scored between 0-3, for a total scale range of 0 to 57. | The study was suspended after initial enrollment and treatment in response to COVID-19. The number of subjects for this outcome subsequently reflects only those enrolled until initial suspension and randomly selected to complete the COHIP-SF scale. | Posted | Mean | Standard Deviation | Total COHIP-SF score | Six months after initial treatment. |
|
|
|
| Secondary | School Attendance | Annual school attendance (chronic absenteeism) at the school level as recorded by the New York City Department of Education. In evaluating this outcome, we assessed school-level data on the proportion of students who were absent. Additionally, we obtained data from an additional 15 schools which met inclusion criteria but did not participate in the trial as a non-randomized comparison group. This allowed us to compare schools in the experimental group to those in the active control, as well as to a non-randomized untreated group of schools. | For this outcome schools were assessed for attendance, individual level data was not collected. | Posted | Number | 95% Confidence Interval | Beta coefficient comparing exp to ctl | 4 years after initial baseline observation | Schools | Schools |
|
|
|
| Secondary | Academic Performance | Children participating in schools assigned to each arm of the trial that received care were to have their academic performance evaluated. This outcome was to use academic performance data collected by the school, not investigators. | Data were not available to be collected due to COVID-19 | Posted | 4 years after initial baseline observation |
|
|
| 0 |
| 3,739 |
| 0 |
| 3,739 |
| 0 |
| 3,739 |
| EG001 | Active Control | Pits and fissures on all bicuspids and molar teeth will be sealed with glass ionomer sealants (GC Fuji IX). Glass ionomer sealants (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) and atraumatic restorations | 0 | 3,679 | 0 | 3,679 | 0 | 3,679 |
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