Dental CariesNCT03442309
Comparative Effectiveness of School-based Caries Prevention
A study testing Silver Diamine Fluoride, Fluoride Varnishes and Glass Ionomer in people with Dental Caries and Quality of Life, run by NYU College of Dentistry at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Quality of Life
- What is being tested?
- Silver Diamine Fluoride, Fluoride Varnishes and Glass Ionomer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,418 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University College of Dentistry
New York, New York, 10010
About this study
Official title: Silver Diamine Fluoride Versus Therapeutic Sealants for the Arrest and Prevention of Dental Caries in Low-income Minority Children
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.
Read the detailed description
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.
- Conditions
- Dental Caries, Quality of Life
- Being tested
- Silver Diamine Fluoride, Fluoride Varnishes, Glass Ionomer
- Keywords
- dental caries, caries arrest, caries prevention, quality of life, silver diamine fluoride, sealants, interim therapeutic restorations, student achievement, school attendance
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Diamine FluorideDevice
Also called Advantage Arrest
Silver diamine fluoride (SDF)
Fluoride VarnishesDevice
Fluoride varnish (FV)
Glass IonomerDevice
Glass Ionomer Sealants (GC Fuji IX)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Silver Diamine Fluoride; Device: Fluoride Varnishes |
| 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. Receives: Device: Fluoride Varnishes; Device: Glass Ionomer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Participants were evaluated biannually over a total of four years or until lost to follow-up, whichever occurred first.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 4 years after initial baseline observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Feb 2019
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel, non-inferiority cluster randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7,418 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU College of Dentistry
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Boston University, New York City Department of Health and Mental Hygiene
- Responsible party
- Principal investigator, Richard Niederman, NYU College of Dentistry
- Investigators
- Richard Niederman, DMD, Principal investigator, NYU Langone HealthRyan R Ruff, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442309
- Sponsor's protocol ID
- i17-00578
- Status last verified
- Feb 2025
- First submitted
- 9 Feb 2018
- Last updated
- 26 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Individual participant data could be shared with proper approval from participating organizations for relevant and appropriate requests.
Publications
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.
PubMed 40489112Ruff 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.
PubMed 38436947Ruff 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.
PubMed 37500236Ruff 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.
PubMed 36757696Ruff 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.
PubMed 30257696
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silver Diamine Fluoride Versus Therapeutic Sealants for the Arrest and Prevention of Dental Caries in Low-income Minority Children
- ClinicalTrials.gov ID
- NCT03442309
- Acronym / sponsor ID
- i17-00578
- Conditions
- Dental Caries, Quality of Life
- Keywords
- dental caries, caries arrest, caries prevention, quality of life, silver diamine fluoride, sealants, interim therapeutic restorations, student achievement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,418 participants (actual)
- Lead sponsor
- NYU College of DentistryUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Boston University, New York City Department of Health and Mental Hygiene
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Posted 26 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel, non-inferiority cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Simple Prevention | Experimental | Device: Silver Diamine Fluoride, Device: Fluoride VarnishesOne 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 | Device: Fluoride Varnishes, Device: Glass IonomerPits 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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silver Diamine FluorideAlso: Advantage ArrestSilver diamine fluoride (SDF) | Device | Simple Prevention |
| Fluoride VarnishesFluoride varnish (FV) | Device | Complex prevention, Simple Prevention |
| Glass IonomerGlass Ionomer Sealants (GC Fuji IX) | Device | Complex prevention |
Primary outcome
Proportion of Subjects With All Caries Arrested
Time frame: Two years
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).
Prevalence of Dental Caries as Measured by a Clinical Oral Examination
Time frame: Participants were evaluated biannually over a total of four years or until lost to follow-up, whichever occurred first.
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.
3 secondary outcomes
Oral Health-Related Quality of Life
Time frame: Six months after initial treatment.
School Attendance
Time frame: 4 years after initial baseline observation
Academic Performance
Time frame: 4 years after initial baseline observation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40489112Ruff 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.
- Derived from this study: PubMed 38436947Ruff 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.
- Derived from this study: PubMed 37500236Ruff 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.
- Derived from this study: PubMed 36757696Ruff 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.
- Derived from this study: PubMed 30257696Ruff 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.
- Individual participant dataSharing planned: Undecided. Individual participant data could be shared with proper approval from participating organizations for relevant and appropriate requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Niederman, DMD principal investigator
NYU Langone Health
Ryan R Ruff, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver Diamine Fluoride, Fluoride Varnishes and Glass Ionomer in people with Dental Caries and Quality of Life, run by NYU College of Dentistry at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects With All Caries Arrested (time frame: Two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03442309, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.