Nanozymes in Endodontics

NCT07518901 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 859377
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Root Canal Infection; Apical Periodontitis; Endodontic Disease

Keywords

Nanozymes; Root canal irrigants; Nanotechnology; iron oxide nanoparticles

Outcome Measures

Primary Outcomes (1)

• 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.

  1 Year

Secondary Outcomes (1)

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

  2 Years

Study Arms (2)

Nanozyme treatment

EXPERIMENTAL

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.

Drug: Nanozyme treatment

Sodium hypochlorite

ACTIVE COMPARATOR

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.

Drug: Control (Standard treatment)

Interventions

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.

Also known as: NaOCl, Sodium hypochlorite

Sodium hypochlorite

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).

Also known as: Iron oxide nanoparticles, Feraheme, Ferumoxytol

Nanozyme treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Dental Medicine, Department of Endodontics

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 1. Kakehashi S, Stanley HR, Fitzgerald RJ. The effects of surgical exposures of dental pulps in germ-free and conventional laboratory rats. Oral Surgery, Oral Medicine, Oral Pathology. 1965/09/01/ 1965;20(3):340-349. doi:https://doi.org/10.1016/0030-4220(65)90166-0 2. Bergenholtz G. Micro-organisms from necrotic pulp of traumatized teeth. Odontol Revy. 1974;25(4):347-58. 3. Kerekes K, Tronstad L. Long-term results of endodontic treatment performed with a standardized technique. Journal of Endodontics. 1979/03/01/ 1979;5(3):83-90. doi:https://doi.org/10.1016/S0099-2399(79)80154-5 4. Bukhari S, Kim D, Liu Y, Karabucak B, Koo H. Novel Endodontic Disinfection Approach Using Catalytic Nanoparticles. J Endod. May 2018;44(5):806-812. doi:10.1016/j.joen.2017.12.003 5. Ricucci D, Siqueira JF, Jr. Biofilms and apical periodontitis: study of prevalence and association with clinical and histopathologic findings. J Endod. Aug 2010;36(8):1277-88. doi:10.1016/j.joen.2010.04.007 6. SJÖGREN U, FIGDOR D, PERSSON S, SUNDQVIST G. Influence of infection at the time of root filling on the outcome of endodontic treatment of teeth with apical periodontitis. International Endodontic Journal. 1997;30(5):297-306. doi:https://doi.org/10.1046/j.1365-2591.1997.00092.x 7. Ricucci D, Siqueira JF, Bate AL, Pitt Ford TR. Histologic Investigation of Root Canal-treated Teeth with Apical Periodontitis: A Retrospective Study from Twenty-four Patients. Journal of Endodontics. 2009/04/01/ 2009;35(4):493-502. doi:https://doi.org/10.1016/j.joen.2008.12.014 8. Babeer A, Liu Y, Ren Z, et al. Ferumoxytol nanozymes effectively target chronic biofilm infections in apical periodontitis. J Clin Invest. Nov 26 2024;doi:10.1172/jci183576 9. Huang Y, Liu Y, Pandey NK, et al. Iron oxide nanozymes stabilize stannous fluoride for targeted biofilm killing and synergistic oral disease prevention. Nature Communications. 2023/09/29 2023;14(1):6087. doi:10.1038/s41467-023-41687-8

  BACKGROUND

MeSH Terms

Conditions

Periapical Periodontitis; Dental Pulp Diseases

Interventions

Magnetic Iron Oxide Nanoparticles; Ferrosoferric Oxide; Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Tooth Diseases

Intervention Hierarchy (Ancestors)

Metal Nanoparticles; Nanoparticles; Nanostructures; Manufactured Materials; Technology, Industry, and Agriculture; Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals; Hypochlorous Acid; Chlorine Compounds; Oxides; Oxygen Compounds; Sodium Compounds

Central Study Contacts

Nadasinee Jaruchotiratanasakul, DDS, DScD Candidate

CONTACT

2155264666; nadaja@upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair and Professor of Endodontics

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The supporting information will be available with the publication.

Locations

US (1)