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NCT Number: NCT07518901

Nanozymes in Endodontics

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Penn Dental Medicine, Department of Endodontics

Philadelphia, Pennsylvania, 19104, United States

Location contact

Nadasinee Jaruchotiratanasakul, DDS, DScD

CONTACT

[email protected]

215-526-4666

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients willing to participate in the study.
  • Patients are 18 years or above.
  • Non-contributory medical history (Patient can be seen for regular dental appointment in PDM; ASA classes I and II).
  • Tooth requiring root canal treatment with radiographic presence of periapical radiolucency and
  • responding to thermal sensitivity testing negatively (Difluordichlormethane at 50 °C, Endo-Ice,
  • Coltène/Whaledent Inc., Cuyahoga Falls, Ohio) or a negative response to EPT testing.
  • Tooth with adequate remaining tooth structure for proper isolation with rubber dam.
  • No history of previous endodontic treatment on the tooth.
  • Teeth with single roots or multirooted teeth.

Exclusion criteria

  • Self-reported pregnancy.
  • Patients requiring antibiotic premedication prior to dental treatment.
  • Patients with multiple drug allergies.
  • Patients with known hypersensitivity to Ferumoxytol nanoparticles or any iron products.
  • Patients who are scheduled for MRI for the head region within three months after Ferumoxytol nanoparticles application.
  • Periodontal changes (pockets 3 mm, mobility Grade I, or gingival edema).
  • Patients who cannot return for a subsequent appointment or follow-ups.
  • Radiographic presence of resorptive processes.
  • Cracked and fractured teeth.

Treatment and study plan

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).

Other names: Iron oxide nanoparticles, Feraheme, Ferumoxytol

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.

Other names: NaOCl, Sodium hypochlorite

Primary outcomes

  1. The change in bacterial count between the experimental group (Ferumoxytol/H2O2) and the standard of care (NaOCl) group.

    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.

Secondary outcomes

  1. Periapical Bone Changes from Baseline in Periapical Radiographs at 6, 12, and 24 Months Follow Up

    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:

    • Normal periapical structures.
    • Small changes in the bone structure.
    • Change in the bone structure with mineral loss.
    • Periodontitis with a well-defined radiolucent area.
    • Severe periodontitis with exacerbating features. Success is defined as either complete (radiographic resolution of a periapical lesion - the radiographic sign of inflammatory processes surrounding a root tip) or incomplete healing (scar tissue formation) and failure includes uncertain healing (radiographic reduction of a periapical lesion or same lesion size) or unsatisfactory healing (increase in lesion size) as determined on the radiograph.

Study contacts

Contact information is provided by the study sponsor or research team.

Nadasinee Jaruchotiratanasakul, DDS, DScD Candidate

CONTACT

[email protected]

2155264666

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Ferumoxytol Nanozymes for Biofilm Disruption: A Clinical Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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