A New Clinical Use of Ferumoxytol Nanoparticles: An Antibiofilm Treatment

NCT06110494 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 828211
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational is study is to develop a protocol for root canal biofilms disinfection using a clinically approved and commercially available iron oxide nanoparticle formulation Ferumoxytol/H2O2 treatments. This protocol will be testing local single topical application of Ferumoxytol within the root canal system in patients going through routine root canal treatment, evaluate its potential as anti-biofilm treatment and compare it to the clinical gold standard disinfecting solution sodium hypochlorite (positive control) and saline (negative control).

Conditions

Apical Periodontitis; Pulp Disease, Dental

Keywords

Pulp infection; Nanotechnology; antibacterial; disinfection; iron oxide nanoparticles

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome Parameter Will be the Difference in Bacterial Reduction Between the Experimental and Control Disinfection Groups Group (Ferumoxytol) and Comparison Groups (Positive and Negative Controls).

  This study is designed to evaluate the antibacterial efficacy of Ferumoxytol/H2O2 and to compare it to the gold standard disinfection solution (NaOCl) and negative control solution (NaCl). The outcome will be evaluated by taking bacterial samples from the root canals during routine root canal treatment before and after applying different disinfection protocols. The disinfection efficacy was calculated by comparing the difference in microbial CFU reduction (post treatment sample/pretreatment sample) between the three disinfection protocols

  baseline (pretreatment) and after 10 minutes of treatment (post treatment)

Secondary Outcomes (2)

• The Effect of Additional (Supplementary) Irrigation and Adjunctive Irrigant (NaOCl) Activation Using Passive Ultrasonic Activation After Irrigation With Experimental and Control Irrigants.

  the baseline of this measurement starts right after treatment with either experimental, negative or positive control agent (S2). This measurement ends after irrigating the canals with NaOCl and irritant activation for 3 minutes.

• The Overall Effect of Antimicrobial Irrigation of Infected Root Canals Using Experimental and Control Irrigants, in Addition to Supplementary Irrigant (NaOCl) Activation.

  This measure starts at baseline (pretreatment) (S1). This measure ends after 10 minutes of treatment with either experimental, positive or negative control irrigants and additional 3 minutes of supplementary irrigation (S3)

Study Arms (3)

Iron oxide nanoparticles treatment Ferumoxytol/H2O2

EXPERIMENTAL

After access preparation with sterile burs and sterile saline irrigation and working length determination as part of routine root canal treatment, and after obtaining a pre-treatment bacteriological samples, 2 mL of a mixture of Ferumoxytol (6mg/mL)/H2O2(3%) was introduced into the canal. Canals were instrumented with 15/0.04, 20/0.04, and 25/0.04 rotary files using 2 mL of treatment solution after each file with a total of 8 mL of solution used and a total contact time of 10 minutes.

Drug: Iron oxide nanoparticles treatment Ferumoxytol/H2O2; Drug: supplementary irrigation

Sodium Hypochlorite (NaOCl)

ACTIVE COMPARATOR

After access preparation with sterile burs and sterile saline irrigation and working length determination as part of routine root canal treatment, and after obtaining a pre-treatment bacteriological samples, 2 mL of 3% NaOCl was introduced into the canal. Canals were instrumented with 15/0.04, 20/0.04, and 25/0.04 rotary files using 2 mL of solution after each file with a total of 8 mL of treatment solution used and a total contact time of 10 minutes.

Drug: NaOCl; Drug: supplementary irrigation

Saline (NaCl)

PLACEBO COMPARATOR

After access preparation with sterile burs and sterile saline irrigation and working length determination as part of routine root canal treatment, and after obtaining a pre-treatment bacteriological samples, 2 mL of 0.89% NaCl was introduced into the canal. Canals were instrumented with 15/0.04, 20/0.04, and 25/0.04 rotary files using 2 mL of treatment solution after each file with a total of 8 mL of solution used and a total contact time of 10 minutes.

Drug: NaCl; Drug: supplementary irrigation

Interventions

Iron oxide nanoparticles treatment Ferumoxytol/H2O2 DRUG

Participants receive a topical treatment through a root canal irrigation needle containing A mixture of 6mg/mL Ferumoxytol nanoparticles solution mixed with 3% H2O2 for 10 minutes contact time

Also known as: Fer, Feraheme

Iron oxide nanoparticles treatment Ferumoxytol/H2O2

NaOCl DRUG

Participants receive a topical treatment through a root canal irrigation needle containing 3% NaOCl for 10 minutes contact time

Also known as: Sodium Hypochlorite, Active comparator

Sodium Hypochlorite (NaOCl)

NaCl DRUG

Participants receive a topical treatment through a root canal irrigation needle containing 0.89% NaCl for 10 minutes contact time

Also known as: Placebo comparator, saline

Saline (NaCl)

supplementary irrigation DRUG

All canals in all groups were irrigated with 2 mL of 3% NaOCl, followed by ultrasonic irrigant activation for 30s twice. seconds. This step was repeated once again making the total activation time 1 min and the total contact time of the irrigant 3 min. Upon completion of irrigation, a third bacterial sample (S3) was taken following the deactivation, washing, drying, and sampling steps as described previously

Also known as: NaOCl with passive ultrasonic activation, adjunctive irrigation step

Iron oxide nanoparticles treatment Ferumoxytol/H2O2; Saline (NaCl); Sodium Hypochlorite (NaOCl)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients to welling 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) and Negatively 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 canal and single and roots with single canals in 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 Fer nanoparticles application.
• Periodontal changes (pockets 3 mm, mobility Grade I or gingival edema).
• Radiographic presence of resorptive processes.
• Cracked and fractured teeth.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Periapical Periodontitis; Dental Pulp Diseases

Interventions

Iron, Dietary; Ferrosoferric Oxide; Sodium Hypochlorite; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Iron Compounds; Inorganic Chemicals; Ferric Compounds; Ferrous Compounds; Minerals; Hypochlorous Acid; Chlorine Compounds; Oxides; Oxygen Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid

Limitations and Caveats

we emphasize the limitation of our clinical study. Limitations include the small sample size

Results Point of Contact

• Title: Dr. Bekir Karabucak Chair of the Department of Endodontics
• Organization: University of Pennsylvania

bekirk@upenn.edu

215-898-4927

Study Officials

• Bekir Karabucak, DMD, MS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: July 13, 2020
• Primary Completion: March 10, 2022
• Study Completion: March 10, 2022
• Last Updated: August 28, 2024
• Results First Posted: August 28, 2024

Record last verified: 2024-08

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)