A Phase 3 interventional study of Silver Diamine Fluoride (38%) and Glass Ionomer Sealant in Dental Caries, sponsored by University of Pennsylvania. Recruiting at 1 site in United States. Open to participants aged 5 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by University of Pennsylvania · Phase 3, Interventional, and Prevention
Among 193 studies in Dental Caries with a site in United States — 16 open to participants now, 19 under way, 3 of them phase 3. Dental Caries · United States.
Among the 193 studies in Dental Caries with a site in United States, this one is the 12th largest by planned enrollment of the 168 interventional ones that give a count, is one of 9 that started in 2026, is one of 22 in phase 3, reaches primary completion later than 18 of the 18 other live ones, and was the 185th registered.
1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.
Browse Dental Caries studies →16 of the 193 studies in Dental Caries with a site in United States are open now. Recruiting first, the newest first:
University of Michigan · Sites in United States
University of Michigan · Sites in United States
A.T. Still University of Health Sciences · Sites in United States
University of Massachusetts, Worcester · Sites in United States
Case Western Reserve University · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 86 Dental Caries studies recruiting now, 18 (21%) set no upper age limit and 66 (77%) stop at 75 or younger; 60 take children under 18; 53 take healthy volunteers.
This study: 5 Years to 13 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
193 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 19 · Phase 3 23 · Phase 4 4
First in 1996; this study’s year is marked. 9 started in 2026.
This study's planned enrollment of 1,200 is above the median of 60 across 967 interventional studies indexed under Dental Caries.
Median enrollment 60 across the 168 interventional studies, 264 across the 25 observational. Of the 166 that completed or were terminated, 68 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
44 of 193 have an industry lead sponsor. The 10 most frequent:
University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.
University of Pennsylvania has 2 studies filed under Dental Caries — fewer than ten, so there is no comparison to draw.
6 of the studies in Dental Caries with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07124533Phase 3Loma Linda UniversityEffectiveness of Toothpaste Tablets on Plaque, Gingival Health and Caries Experiences | 2026-12 |
| NCT06588725Vanderbilt University Medical CenterBrief Interventions to Improve Behavior Outcomes and Prevent Cavities | 2027-01 |
| NCT05756413University of IowaBirth to Three - Cavity Free | 2027-03-31 |
| NCT07648212University of MichiganArtificial Intelligence (AI) for Proximal Caries Detection and Its Impact on Treatment Threshold | 2027-05 |
| NCT06714929Virginia Commonwealth UniversityAdvancing Water Security: A Community Participatory School-Based Hydration Intervention | 2027-05-31 |
Among the 193 studies in Dental Caries with a site in United States, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single intervention: Silver diamine fluoride (SDF)
Device: Silver Diamine Fluoride (38%)
Single intervention: Glass Ionomer Cement (GIC) Sealant
Device: Glass Ionomer Sealant
Nonresponse arm: SDF (First stage) + \[SDF + Fluoride Varnish (FV) + Hygiene Intervention (Second Stage)\]
Device: Silver Diamine Fluoride (38%) · Device: Fluoride Varnishes · Behavioral: Hygiene Intervention
Nonresponse arm: SDF (First Stage) + \[Silver Modified Atraumatic Restorative Treatment (SMART) + Sealant (Second Stage)\]
Device: Silver Diamine Fluoride (38%) · Device: Glass Ionomer Sealant
Nonresponse arm: GIC Sealant (First Stage) + \[ART + FV + Hygiene Intervention (Second Stage)\]
Device: Glass Ionomer Sealant · Device: Fluoride Varnishes · Behavioral: Hygiene Intervention
Nonresponse arm: GIC Sealant (First Stage) + \[SMART (Second Stage)\]
Device: Silver Diamine Fluoride (38%) · Device: Glass Ionomer Sealant
Topically applied silver diamine fluoride 38% solution
GIC Dental Sealants
Topically applied fluoride varnish (FV)
Behavioral intervention to improve dental hygiene
Dental Caries Incidence
Number of teeth presenting with new caries
Time frame: Biannual assessment from enrollment to end of treatment (2.5 years)
Caries Prevalence
The prevalence of study participants with dental caries
Time frame: Biannual assessment from enrollment to end of treatment (2.5 years)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Data dictionaries and de-identified patient data will be made available upon reasonable request and approval of a data use agreement.
Supporting information: Study protocol, Statistical analysis plan
Time frame: IPD and supporting information will be available at the end of the trial for five years.
Access criteria: Anyone with an approved data use agreement.
Started Aug 2026 (actual). Primary completion is estimated for Jun 2030, 46 months after the start.
Of 17 phase 3 interventional studies under Dental Caries, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 26. This study's planned 46 months is above that.
How these figures are worked out, and which studies are left out of them.
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