Nanozymes in Endodontics

ConditionsApical Periodontitis Endodontic Disease Root Canal Infection

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Pennsylvania

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

72 Participants

are divided into 2 treatment groups

Group A: Nanozyme treatmentExperimental treatment 1 intervention

Group B: Sodium hypochloriteActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

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

1 Year

Secondary outcomes

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

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: 1. Normal periapical structures. 2. Small changes in the bone structure. 3. Change in the bone structure with mineral loss. 4. Periodontitis with a well-defined radiolucent area. 5. 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.

Time frame

2 Years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Source ClinicalTrials.gov

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