Dental CariesNCT03448107
Comparative Effectiveness of Treatments to Prevent Dental Caries
A study testing Silver Diamine Fluoride, Fluoride Varnishes and Glass Ionomer in people with Dental Caries, 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
- 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
- 3,345 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2017to 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 with a previously employed caries prevention program operating in rural areas, with official Title 1 status, and located in a health professional shortage area. Within participating schools, all children are eligible to participate in the study. Those with informed consent and assent will receive care.
Who cannot join
- Children 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: Comparative Effectiveness of Treatments to Prevent Dental Caries Given to Rural Children in School-based Settings: Protocol for a Cluster Randomized Controlled Trial
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.
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 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.
- Conditions
- Dental Caries
- Being tested
- Silver Diamine Fluoride, Fluoride Varnishes, Glass Ionomer
- Keywords
- dental caries, caries arrest, caries prevention, silver diamine fluoride, sealants, interim therapeutic restorations
- 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.
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
Measured: 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
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start20 Sep 2017
- 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 (2)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
- 3,345 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU College of Dentistry
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Richard Niederman, NYU College of Dentistry
- Investigators
- Richard Niederman, DMD, Principal investigator, NYU Langone HealthRyan R Ruff, MPH, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448107
- Sponsor's protocol ID
- i17-01221
- Other IDs
- R01MD011526
- 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
- Yes: Individual participant data could be shared with proper approval from participating organizations for relevant and appropriate requests.
Publications
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.
PubMed 38883737Ruff 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.
PubMed 29654053
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
- Comparative Effectiveness of Treatments to Prevent Dental Caries Given to Rural Children in School-based Settings: Protocol for a Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03448107
- Acronym / sponsor ID
- i17-01221
- Conditions
- Dental Caries
- Keywords
- dental caries, caries arrest, caries prevention, silver diamine fluoride, sealants, interim therapeutic restorations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,345 participants (actual)
- Lead sponsor
- NYU College of DentistryUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 27 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 Hampshire.
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 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.
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 (1 listed)
- Any primary school with a previously employed caries prevention program operating in rural areas, with official Title 1 status, and located in a health professional shortage area. Within participating schools, all children are eligible to participate in the study. Those with informed consent and assent will receive care.
Key exclusion criteria (1 listed)
- Children 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
Number of Participants With Arrested Dental Caries, Assessed Using a Clinical Oral Examination
Time frame: Two years
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
Caries Prevention
Time frame: Five years
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
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 38883737Ruff 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.
- Derived from this study: PubMed 29654053Ruff 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.
- Individual participant dataSharing planned: Yes. Individual participant data could be shared with proper approval from participating organizations for relevant and appropriate requests.
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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, MPH, 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, 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 1 inclusion and 1 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?
Number of Participants With Arrested Dental Caries, Assessed Using a Clinical Oral Examination (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 NCT03448107, which also lists 2 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.