Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT06110494
Eligibility Criteria:
Inclusion Criteria:
1. Patients to welling 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 responding to thermal sensitivity testing negatively (difluordichlormethane at 50 °C) (Endo-Ice, Coltène/Whaledent Inc., Cuyahoga Falls, Ohio) and Negatively 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 canal and single and roots with single canals in 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 Fer nanoparticles application.
6. Periodontal changes (pockets 3 mm, mobility Grade I or gingival edema).
7. Radiographic presence of resorptive processes.
8. Cracked and fractured teeth.
9. if one of the inclusion criteria is not met
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06110494
Study Brief:
Protocol Section:
NCT06110494