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NCT03678012 · ClinicalTrials.gov registry record · Early Phase 1
Evaluation of Anti-biofilm Effects of Ferumoxytol (Feraheme) Using an in Situ Biofilm Demineralization Model
A Early Phase 1 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 16
- Enrollment target
NCT03678012: Completed Early Phase 1 study, sponsored by University of Pennsylvania.
NCT03678012 is a Early Phase 1 study that has completed, run by University of Pennsylvania. The registered enrollment target is 16 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03678012, a Early Phase 1 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
To evaluate the effects of a clinically approved and commercially available iron oxide formulation Ferumoxytol (Feraheme®) to control cariogenic biofilms and enamel demineralization. This study will be testing topical application of Ferumoxytol extra-orally using a standard in situ biofilm demineralization model.
Primary Outcome
The effect of the treatments will be analyzed in terms of biochemical and microbiological composition of the biofilm formed. Colony forming unit (CFU) will be used to quantify the number of viable cells in biofilms.
Interventions
- DRUG Hydrogen Peroxide
- DRUG Water
- DRUG Ferumoxytol/Hydrogen peroxide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-06-07 |
| Est. Completion | 2018-08-16 |
| Phase | Early Phase 1 |
What the finished NCT03678012 record still lists
NCT03678012 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which Hydrogen Peroxide is the first listed.
NCT03678012 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03678012 about?
NCT03678012 is a clinical study titled "Evaluation of Anti-biofilm Effects of Ferumoxytol (Feraheme) Using an in Situ Biofilm Demineralization Model". To evaluate the effects of a clinically approved and commercially available iron oxide formulation Ferumoxytol (Feraheme®) to control cariogenic biofilms and enamel demineralization. This study will be testing topical application of Ferumoxytol extra-orally using a standard in situ biofilm demineral...
What is the current status of trial NCT03678012?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 16 participants. The study started on 2018-06-07. Estimated completion is 2018-08-16.
What interventions are being tested in trial NCT03678012?
The interventions under investigation include: Hydrogen Peroxide (DRUG), Water (DRUG), Ferumoxytol/Hydrogen peroxide (DRUG).
Who is sponsoring clinical trial NCT03678012?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03678012's enrollment target sits among peer trials
16 1370th of 2000 higher than 598 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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