Nanozymes in Endodontics

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT07518901
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Apical Periodontitis
  • Endodontic Disease
  • Root Canal Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nanozyme treatment — DRUG
    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).
  • Control (Standard treatment) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nanozyme treatment
    After access preparation with sterile burs and sterile saline irrigation and working length determination, 2 mL of a mixture of Ferumoxytol (6mg/mL)/H2O2(3%) will be introduced into the canal. The root canal systems will be instrumented with XP-Shaper rotary files, a total of 8 mL of solution will be used, and a total contact time of 10 minutes.
  • Active Comparator: Sodium hypochlorite
    After access preparation with sterile burs and sterile saline irrigation and working length determination, 2 mL of a mixture of sodium hypochlorite (NaOCl) will be introduced into the canal. The root canal systems will be instrumented with XP-Shaper rotary files, a total of 8 mL of NaOCl solution will be used, and a total contact time of 10 minutes.

Primary Outcome Measure

The change in bacterial count between the experimental group (Ferumoxytol/H2O2) and the standard of care (NaOCl) group. [ Time Frame: 1 Year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn Dental Medicine, Department of EndodonticsPhiladelphiaPennsylvania19104
Nadasinee Jaruchotiratanasakul, DDS, DScD
[email protected]
215-526-4666

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By research site
Penn Dental Medicine, Department of Endodontics· Philadelphia, PA

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