- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06110494
A New Clinical Use of Ferumoxytol Nanoparticles: An Antibiofilm Treatment
October 25, 2023 updated by: Bekir Karabucak, University of Pennsylvania
Nanozyme-mediated Catalysis for Clinical Treatment of Biofilm Infections
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients presenting to the Department of Endodontics, School of Dental Medicine, University of Pennsylvania for evaluation and routine endodontic treatment of infected, necrotic teeth with chronic apical periodontitis will be asked to take part in the study if they meet the inclusion criteria and volunteer to participate.
After eligibility of the patient is confirmed, the patient will be assigned to treatments through the process of drawing lots from a box that was maintained in a locked cabinet.
Before treatment, patients will be thoroughly informed about the nature, potential risks and alternatives of the study as well as the root canal treatment.
Patients will be presented with a written consent form regarding the above mentioned study characteristics as well as the regular consent forms for the root canal therapy, including the consent form for endodontic treatement, acknowledgement of privacy practices and a patient understanding and informed consent form.
Briefly, the patient will be anesthetized and the tooth isolated with rubber dam.
30% H2O2 followed by 3% NaOCl will be used to disinfect the tooth and the rubber dam.
The removal of caries and the endodontic access will be carried out by sterile high-speed carbide burs.After access preparation with sterile burs and sterile saline irrigation, thermoplastic gutta percha was placed to temporarily block the orifice.
The field, including the pulp chamber, is cleaned and disinfected as described previously.
NaOCl is neutralized with 10% sodium thiosulfate.
Contamination control sample (S0) will be taken from the internal cavosurface angle where the paper points will accidentally touch during sampling.After initial access to the root canal orifices, working length will be measured and a bacteriological sample will be taken from the targeted canals (S1).
Sterile paper points will be placed into the canal, allowed to saturate and then transferred to a vial containing liquid dental transport media (LDT).
For NaOCl group (Positive control), canals will be instrumented up to size 25/0.04
taper using 2mL of 3% NaOCl in between files.
For Ferumoxytol/H2O2 group, canals will be instrumented up to size 25/0.04
taper using 2mL of a mixture of 6 mg/ml of Ferumoxytol with 3% H2O2.
For saline only group, canals will be instrumented up to size 25/0.04
taper using 2mL of saline.
When the final 25/0.04 taper apical size is reached, a second bacterial sample will be taken (S2).
Before all samplings, sodium hypochlorite, Feramehe/ H2O2 and Saline.
Canal contents will be deactivated with sodium thiosulphate for NaOCl,and saline wash will be used for Fer/H2O2 and saline treatments.
A wash step with 1 mL saline was done to wash the deactivating solution, and paper points were used to dry the canals.
A second bacterial sample was taken (S2) by placing LDT inside the canal, agitating it with 25/0.02
Hedstrom hand file, followed by absorbing the content with 2 paper points placed in the canal for 30 seconds each.
The paper points will be placed inside a tube containing LDT.
The remaining treatment sequences of the routine root canal therapy will be carried out after these procedures including further root-end enlargement and final routine irrigation protocol.
The root canals will be dried with paper points, a medication (calcium hydroxide) will be placed and the teeth sealed with a temporary restoration.
Patients will return after one to four weeks for completion of the root filling.
For the any of the groups, the treatment procedures carried out during this investigation do not differ from the standard root canal treatment protocol with the exception of additional irrigation step with the experimental solution and the bacteriologic sampling procedures.
The paper points used to take the bacteriological sampling will be transferred to the microbiology laboratory using a vial containing 1 ml of LDT.
The laboratory procedures will be performed at the University of Pennsylvania Leon Levy Oral Health Sciences Building of the School of Dental Medicine in the Microbiology Laboratory Vial labels will contain information on tooth number, sample number (S0-S1-S2) and the experimental group.
The samples will be diluted and plated in culture plates.
The culture plates will be incubated at 37°C in an anaerobic glove box containing 5% hydrogen, 5% CO2 and balance N2 for 5 days.
After incubation the number of colony forming units will be determined by using a stereoscope.
ANOVA and Students t-test will be used for statistical analysis.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
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 Fer nanoparticles application.
- Periodontal changes (pockets 3 mm, mobility Grade I or gingival edema).
- Radiographic presence of resorptive processes.
- Cracked and fractured teeth.
- if one of the inclusion criteria is not met
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Iron oxide nanoparticles treatment Ferumoxytol/H2O2
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.
|
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
Other Names:
|
Active Comparator: Sodium Hypochlorite (NaOCl)
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.
|
Participants receive a topical treatment through a root canal irrigation needle containing 3% NaOCl for 10 minutes contact time
Other Names:
|
Placebo Comparator: Saline (NaCl)
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.
|
Participants receive a topical treatment through a root canal irrigation needle containing 0.89% NaCl for 10 minutes contact time
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary outcome parameter will be the difference in bacterial reduction between the experimental group (Ferumoxytol) and comparison groups (positive and negative controls).
Time Frame: baseline and after 10 minutes of treatment
|
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 after applying different disinfection protocols.
Bacteria from each sample will be quantified.
|
baseline and after 10 minutes of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bekir Karabucak, DMD, MS, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 13, 2020
Primary Completion (Actual)
March 10, 2022
Study Completion (Actual)
March 10, 2022
Study Registration Dates
First Submitted
October 25, 2023
First Submitted That Met QC Criteria
October 25, 2023
First Posted (Actual)
October 31, 2023
Study Record Updates
Last Update Posted (Actual)
October 31, 2023
Last Update Submitted That Met QC Criteria
October 25, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Periodontal Diseases
- Mouth Diseases
- Tooth Diseases
- Jaw Diseases
- Periapical Diseases
- Periodontitis
- Periapical Periodontitis
- Dental Pulp Diseases
- Stomatognathic Diseases
- Anti-Infective Agents
- Hematinics
- Pharmaceutical Solutions
- Parenteral Nutrition Solutions
- Disinfectants
- Ferrosoferric Oxide
- Sodium Hypochlorite
- Eusol
Other Study ID Numbers
- 828211
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Only the participants chart numbers were collected during the study.
The study protocol, statistical analysis plan and informed consent form will be published as supporting information with the final manuscript
IPD Sharing Time Frame
the supporting information will be available with the publication
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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