Status:
COMPLETED
A New Clinical Use of Ferumoxytol Nanoparticles: An Antibiofilm Treatment
Lead Sponsor:
University of Pennsylvania
Conditions:
Apical Periodontitis
Pulp Disease, Dental
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 Ferumox...
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 api...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2022
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06110494
Start Date
July 13 2020
End Date
March 10 2022
Last Update
August 28 2024
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104