Ferumoxytol Nanozymes for Biofilm Disruption: A Clinical Study
University of Pennsylvania
Summary
The antimicrobial efficacy and healing potential of clinically approved ferumoxytol nanozymes versus the standard 3% NaOCl irrigant will be evaluated in adults undergoing endodontic treatment. Building on prior protocols that demonstrated ferumoxytol nanozymes antimicrobial activity as a root canal irrigant, ferumoxytol solution will be applied topically, assessment of clinical and radiographical findings will determine its potential as a novel disinfection and its long-term outcome.
Description
This study aims to fill critical knowledge gaps identified in prior clinical findings by optimizing the integration of nanozymes into endodontic workflows and thereby improving treatment outcomes for teeth with apical periodontitis. The study will evaluate the topical application of a low-dose ferumoxytol formulation (Feraheme/H2O2) within the prepared canal system of patients undergoing routine root canal therapy. Antimicrobial efficacy will be compared to the standard sodium hypochlorite irrigant via intracanal microbial sampling. Periapical tissue regeneration and long-term clinical outcome…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients willing to participate in the study. 2. Patients are 18 years or above. 3. Non-contributory medical history (Patient can be seen for regular dental appointment in PDM; ASA classes I and II). 4. Tooth requiring root canal treatment with radiographic presence of periapical radiolucency and 1. responding to thermal sensitivity testing negatively (Difluordichlormethane at 50 °C, Endo-Ice, 2. Coltène/Whaledent Inc., Cuyahoga Falls, Ohio) or a negative response to EPT testing. 5. Tooth with adequate remaining tooth structure for proper isolation with rubber da…
Interventions
- DrugNanozyme treatment
Experimental arm: topical intra-canal irrigation with ferumoxytol (Feraheme®) diluted to 6 mg/mL in 0.1 M sodium acetate, activated with 3% H₂O₂. The solution is instilled into an isolated, dried canal, physically agitated for \~60 s to promote nanozyme activation and convective mixing, held for a brief contact time (\<10 min), then aspirated per SOP; post-treatment intracanal sterile paper-point samples are collected. Topical nanozyme mechanism (catalytic ROS generation from low-dose H₂O₂), defined low topical dose and brief contact time (non-systemic).
- DrugControl (Standard treatment)
Control arm: standard clinical irrigation with 3% sodium hypochlorite (NaOCl) using matched total volume and institutional activation method, with identical pre/post sampling and follow-up.
Location
- Penn Dental Medicine, Department of EndodonticsPhiladelphia, Pennsylvania