Dental CariesPhase 3BASICSNCT07265830
Building Adaptive School-based Interventions for Caries
A Phase 3 study testing Silver Diamine Fluoride (38%), Glass Ionomer Sealant and Fluoride Varnishes in people with Dental Caries, run by University of Pennsylvania at 1 site in United States.
Trial summary
Dental caries (tooth decay) is the world's most prevalent noncommunicable disease. Current preventive and therapeutic treatments are available that can be provided in a school-based health service environment. Read more about this study
- Who is it for?
- Ages 5 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Silver Diamine Fluoride (38%), Glass Ionomer Sealant and Fluoride Varnishes
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2026to Jun 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Be enrolled in participating schools
- Be between the ages of 5 and 13 years
- Provide parental/guardian informed consent
- Child assent
Who cannot join
- Ulcerative gingivitis or stomatitis
- Known sensitivity to silver or other heavy-metal ions
- More than six affected sites
- Those who have had full mouth gingivectomies
- Patients showing abnormal skin sensitization in daily circumstances
- Those who have had pulp capping
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Smiles For Students
Glenwood Springs, Colorado, 81601
About this study
Official title: The Building Adaptive School-based Interventions for Caries Study (BASICS): A Phase III Sequential, Multiple-Assignment, Randomized Trial of Minimally Invasive Therapies to Reduce Treatment Nonresponse
Dental caries (tooth decay) is the world's most prevalent noncommunicable disease. Current preventive and therapeutic treatments are available that can be provided in a school-based health service environment. However, not all children respond to care, and school programs can result in under- or over-treatment, leaving children at high risk. The Building Adaptive School-based Interventions for Caries (BASICS) study will identify the optimal sequence and intensity of these treatments to minimize nonresponse, creating adaptive interventions tailored to specific needs in order to personalize school-based dental medicine.
Read the detailed description
Dental caries is the world's most prevalent noncommunicable disease, with considerable health disparities found in low-income rural white children and low-income urban Hispanic/Latino and black children. To combat this silent epidemic, school-based caries prevention can increase access to critical dental care, reducing caries risk and mitigating its severe health and socioemotional consequences. However, despite the use of evidence-based interventions, approximately 30% of children participating in school-based caries prevention fail to respond to treatment ("nonresponse"), developing new caries and remaining at high risk for subsequent complications. Additionally, the sustainability of school-based prevention is jeopardized due to prohibitive costs, limitations of the professional workforce, and relying on treatments that are not optimized for individual patient needs. The Building Adaptive School-based Interventions for Caries (BASICS) study will develop and assess personalized, resource-efficient approaches to school caries prevention using adaptive interventions. Evaluated by embedding dynamic treatment regimes (DTR) within a Sequential, Multiple-Assignment, Randomized Trial (SMART) design, investigators will explore a number of hypotheses related to adaptive preventive interventions for caries. First, investigators will test the effects of adaptive interventions on reducing treatment nonresponse using generalized linear mixed models, followed by identifying the best dynamic treatment regime using augmented inverse probability weighted marginal structural models for causal effect estimation. Investigators will subsequently build an optimal adaptive intervention using Q-learning, tailoring treatments to individual patient attributes and responsiveness. Investigators will conclude with a microcosting analysis of the adaptive interventions, ultimately quantifying the intervention costs under different implementation scenarios and taking the first step towards understanding how much payers should reimburse for adaptive interventions. Successful completion of this project will produce resource-efficient adaptive prevention interventions (API) to reduce treatment nonresponse and improve oral health.
- Conditions
- Dental Caries
- Being tested
- Silver Diamine Fluoride (38%), Glass Ionomer Sealant, Fluoride Varnishes, Hygiene Intervention
- Keywords
- Dental caries, Adaptive interventions, Prevention, Child, Dynamic treatment regimes, SMART
- 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 Fluoride (38%)Device
Topically applied silver diamine fluoride 38% solution
Glass Ionomer SealantDevice
GIC Dental Sealants
Fluoride VarnishesDevice
Topically applied fluoride varnish (FV)
Hygiene InterventionBehavioural
Behavioral intervention to improve dental hygiene
| Study group | Role | What they receive |
|---|---|---|
| Subgroup A, SDF only | Experimental | Single intervention: Silver diamine fluoride (SDF) Receives: Device: Silver Diamine Fluoride (38%) |
| Subgroup D, Sealant only | Active comparator | Single intervention: Glass Ionomer Cement (GIC) Sealant Receives: Device: Glass Ionomer Sealant |
| Subgroup B, SDF + FV + Hygiene Intervention | Experimental | Nonresponse arm: SDF (First stage) + [SDF + Fluoride Varnish (FV) + Hygiene Intervention (Second Stage)] Receives: Device: Silver Diamine Fluoride (38%); Device: Fluoride Varnishes; Behavioral: Hygiene Intervention |
| Subgroup C, SDF + SMART + Sealant | Experimental | Nonresponse arm: SDF (First Stage) + [Silver Modified Atraumatic Restorative Treatment (SMART) + Sealant (Second Stage)] Receives: Device: Silver Diamine Fluoride (38%); Device: Glass Ionomer Sealant |
| Subgroup E, Sealant + SMART + FV + Hygiene Intervention | Experimental | Nonresponse arm: GIC Sealant (First Stage) + [ART + FV + Hygiene Intervention (Second Stage)] Receives: Device: Glass Ionomer Sealant; Device: Fluoride Varnishes; Behavioral: Hygiene Intervention |
| Subgroup F, Sealant + SMART | Experimental | Nonresponse arm: GIC Sealant (First Stage) + [SMART (Second Stage)] Receives: Device: Silver Diamine Fluoride (38%); Device: Glass Ionomer Sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Caries Incidence
Number of teeth presenting with new caries
Measured: Biannual assessment from enrollment to end of treatment (2.5 years)
Caries Prevalence
The prevalence of study participants with dental caries
Measured: Biannual assessment from enrollment to end of treatment (2.5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start18 Aug 2026
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- BASICS is a phase-III Sequential, Multiple-Assignment, Randomized Trial (SMART)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Ryan R Ruff, PhD, MPH, Principal investigator, New York University College of Dentistry/Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265830
- Sponsor's protocol ID
- i24-01908
- Other IDs
- R01MD019938
- Acronym
- BASICS
- Status last verified
- Sep 2026
- First submitted
- 20 Nov 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data dictionaries and de-identified patient data will be made available upon reasonable request and approval of a data use agreement.
Publications
Ruff RR, Godin TB, Huang S. Building Adaptive School-Based Interventions for Caries (BASICS): study protocol for a Sequential, Multiple Assignment, Randomized Trial. Trials. 2026 Mar 4;27(1):292. doi: 10.1186/s13063-026-09588-5.
PubMed 41776554
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Building Adaptive School-based Interventions for Caries Study (BASICS): A Phase III Sequential, Multiple-Assignment, Randomized Trial of Minimally Invasive Therapies to Reduce Treatment Nonresponse
- ClinicalTrials.gov ID
- NCT07265830
- Acronym / sponsor ID
- BASICS / i24-01908
- Conditions
- Dental Caries
- Keywords
- Dental caries, Adaptive interventions, Prevention, Child, Dynamic treatment regimes, SMART
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 18 Aug 2026 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
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 world's most prevalent noncommunicable disease. Current preventive and therapeutic treatments are available that can be provided in a school-based health service environment. However, not all children respond to care, and school programs can result in under- or over-treatment, leaving children at high risk. The Building Adaptive School-based Interventions for Caries (BASICS) study will identify the optimal sequence and intensity of these treatments to minimize nonresponse, creating adaptive interventions tailored to specific needs in order to personalize school-based dental medicine.
Detailed description
Dental caries is the world's most prevalent noncommunicable disease, with considerable health disparities found in low-income rural white children and low-income urban Hispanic/Latino and black children. To combat this silent epidemic, school-based caries prevention can increase access to critical dental care, reducing caries risk and mitigating its severe health and socioemotional consequences. However, despite the use of evidence-based interventions, approximately 30% of children participating in school-based caries prevention fail to respond to treatment ("nonresponse"), developing new caries and remaining at high risk for subsequent complications. Additionally, the sustainability of school-based prevention is jeopardized due to prohibitive costs, limitations of the professional workforce, and relying on treatments that are not optimized for individual patient needs. The Building Adaptive School-based Interventions for Caries (BASICS) study will develop and assess personalized, resource-efficient approaches to school caries prevention using adaptive interventions. Evaluated by embedding dynamic treatment regimes (DTR) within a Sequential, Multiple-Assignment, Randomized Trial (SMART) design, investigators will explore a number of hypotheses related to adaptive preventive interventions for caries. First, investigators will test the effects of adaptive interventions on reducing treatment nonresponse using generalized linear mixed models, followed by identifying the best dynamic treatment regime using augmented inverse probability weighted marginal structural models for causal effect estimation. Investigators will subsequently build an optimal adaptive intervention using Q-learning, tailoring treatments to individual patient attributes and responsiveness. Investigators will conclude with a microcosting analysis of the adaptive interventions, ultimately quantifying the intervention costs under different implementation scenarios and taking the first step towards understanding how much payers should reimburse for adaptive interventions. Successful completion of this project will produce resource-efficient adaptive prevention interventions (API) to reduce treatment nonresponse and improve oral health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- BASICS is a phase-III Sequential, Multiple-Assignment, Randomized Trial (SMART)
| Arm | Type | Receives |
|---|---|---|
| Subgroup A, SDF only | Experimental | Device: Silver Diamine Fluoride (38%)Single intervention: Silver diamine fluoride (SDF) |
| Subgroup D, Sealant only | Active comparator | Device: Glass Ionomer SealantSingle intervention: Glass Ionomer Cement (GIC) Sealant |
| Subgroup B, SDF + FV + Hygiene Intervention | Experimental | Device: Silver Diamine Fluoride (38%), Device: Fluoride Varnishes, Behavioral: Hygiene InterventionNonresponse arm: SDF (First stage) + [SDF + Fluoride Varnish (FV) + Hygiene Intervention (Second Stage)] |
| Subgroup C, SDF + SMART + Sealant | Experimental | Device: Silver Diamine Fluoride (38%), Device: Glass Ionomer SealantNonresponse arm: SDF (First Stage) + [Silver Modified Atraumatic Restorative Treatment (SMART) + Sealant (Second Stage)] |
| Subgroup E, Sealant + SMART + FV + Hygiene Intervention | Experimental | Device: Glass Ionomer Sealant, Device: Fluoride Varnishes, Behavioral: Hygiene InterventionNonresponse arm: GIC Sealant (First Stage) + [ART + FV + Hygiene Intervention (Second Stage)] |
| Subgroup F, Sealant + SMART | Experimental | Device: Silver Diamine Fluoride (38%), Device: Glass Ionomer SealantNonresponse arm: GIC Sealant (First Stage) + [SMART (Second Stage)] |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Be enrolled in participating schools
- Be between the ages of 5 and 13 years
- Provide parental/guardian informed consent
- Child assent
Key exclusion criteria (6 listed)
- Ulcerative gingivitis or stomatitis
- Known sensitivity to silver or other heavy-metal ions
- More than six affected sites
- Those who have had full mouth gingivectomies
- Patients showing abnormal skin sensitization in daily circumstances
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 Fluoride (38%)Topically applied silver diamine fluoride 38% solution | Device | Subgroup A, SDF only, Subgroup B, SDF + FV + Hygiene Intervention, Subgroup C, SDF + SMART + Sealant, Subgroup F, Sealant + SMART |
| Glass Ionomer SealantGIC Dental Sealants | Device | Subgroup C, SDF + SMART + Sealant, Subgroup D, Sealant only, Subgroup E, Sealant + SMART + FV + Hygiene Intervention, Subgroup F, Sealant + SMART |
| Fluoride VarnishesTopically applied fluoride varnish (FV) | Device | Subgroup B, SDF + FV + Hygiene Intervention, Subgroup E, Sealant + SMART + FV + Hygiene Intervention |
| Hygiene InterventionBehavioral intervention to improve dental hygiene | Behavioural | Subgroup B, SDF + FV + Hygiene Intervention, Subgroup E, Sealant + SMART + FV + Hygiene Intervention |
Primary outcome
Dental Caries Incidence
Time frame: Biannual assessment from enrollment to end of treatment (2.5 years)
Number of teeth presenting with new caries
Caries Prevalence
Time frame: Biannual assessment from enrollment to end of treatment (2.5 years)
The prevalence of study participants with dental caries
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Derived from this study: PubMed 41776554Ruff RR, Godin TB, Huang S. Building Adaptive School-Based Interventions for Caries (BASICS): study protocol for a Sequential, Multiple Assignment, Randomized Trial. Trials. 2026 Mar 4;27(1):292. doi: 10.1186/s13063-026-09588-5.
- Individual participant dataSharing planned: Yes. Data dictionaries and de-identified patient data will be made available upon reasonable request and approval of a data use agreement.
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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.
Ryan R Ruff, PhD, MPH principal investigator
New York University College of Dentistry/Epidemiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Silver Diamine Fluoride (38%), Glass Ionomer Sealant and Fluoride Varnishes in people with Dental Caries, run by University of Pennsylvania 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan R Ruff, PhD, MPH (212-998-9663, ryan.ruff@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental Caries Incidence (time frame: Biannual assessment from enrollment to end of treatment (2.5 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 NCT07265830, which also lists 1 linked publication.
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 10 Sep 2026.