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Enrolling By Invitation
NCT07518901
Nanozymes in Endodontics
Conditions: Apical Periodontitis, Endodontic Disease, Root Canal Infection
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 72
Sponsor: University of Pennsylvania
Location: Penn Dental Medicine, Department of Endodontics Philadelphia Pennsylvania
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.
Eligibility Criteria
Inclusion Criteria:
1. Patients willing to participate in the study.
2. Patients are 18 years or above.
3. Non-contributory medical history (Patient can be seen for regular dental appointment in PDM; ASA classes I and II).
4. Tooth requiring root canal treatment with radiographic presence of periapical radiolucency and
1. responding to thermal sensitivity testing negatively (Difluordichlormethane at 50 °C, Endo-Ice,
2. Coltène/Whaledent Inc., Cuyahoga Falls, Ohio) or a negative response to EPT testing.
5. Tooth with adequate remaining tooth structure for proper isolation with rubber dam.
6. No history of previous endodontic treatment on the tooth.
7. Teeth with single roots or multirooted teeth.
Exclusion Criteria:
1. Self-reported pregnancy.
2. Patients requiring antibiotic premedication prior to dental treatment.
3. Patients with multiple drug allergies.
4. Patients with known hypersensitivity to Ferumoxytol nanoparticles or any iron products.
5. Patients who are scheduled for MRI for the head region within three months after Ferumoxytol nanoparticles application.
6. Periodontal changes (pockets 3 mm, mobility Grade I, or gingival edema).
7. Patients who cannot return for a subsequent appointment or follow-ups.
8. Radiographic presence of resorptive processes.
9. Cracked and fractured teeth.
Source: ClinicalTrials.gov (NCT07518901). StuddyBuddy aggregates publicly available trial information.