Penn Dental Medicine, Department of Endodontics
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT07518901
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
Philadelphia, Pennsylvania, 19104, United States
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 outcomes will be assessed at 6-month and 1-year follow-up intervals using cone-beam computed tomography (CBCT).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Other names: Iron oxide nanoparticles, Feraheme, Ferumoxytol
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.
Other names: NaOCl, Sodium hypochlorite
Time frame: 1 Year
By measuring reduction in bacteria colony forming units (CFU) before and after treatment for the experimental group (Ferumoxytol/H2O2) and the standard of care (NaOCl) group, then comparing the two groups.
Samples 1-2 will be taken during the first root canal treatment visit. Sample 1 before cleaning or shaping the root canal. Sample 2 after cleaning and shaping of the root canal using laser or NaOCl. Sample 3 will be taken in the second visit, upon completion of final routine irrigation protocol.
Time frame: 2 Years
Periapical radiographs will be taken at baseline (preoperative) then at 6 months follow up post root canal filling.
Radiographically, Following periapical index (PAI) by Órstavik 1986, description of radiographic findings:
Contact information is provided by the study sponsor or research team.
University of Pennsylvania
Other
Ferumoxytol Nanozymes for Biofilm Disruption: A Clinical Study
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