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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07314866
Eligibility Criteria:
Inclusion Criteria:
* Systemically healthy patients aged 15 to 40 years.
* Mature permanent single-rooted teeth with clinical and radiographic diagnosis of pulp necrosis (or irreversible pulpitis with necrotic findings) associated with periapical radiolucency.
* Probing depth \< 3 mm and no abnormal tooth mobility.
* No previous endodontic treatment or apical surgery on the study tooth.
* Availability of an autologous donor tooth (impacted or nonfunctional third molar indicated for extraction) to obtain pulp tissue.
* Ability and willingness to attend follow-up visits and provide written informed consent.
Exclusion Criteria:
* Systemic conditions that may impair healing (e.g., uncontrolled diabetes mellitus, autoimmune disease) or use of immunosuppressive therapy.
* History of head and neck radiotherapy.
* Pregnancy or lactation.
* Poor oral hygiene or periodontal disease with probing depth ≥ 4 mm.
* Teeth with root fracture, internal/external root resorption, severe canal calcification, or non-restorable crown destruction.
* Inability to comply with follow-up schedule.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
40 Years
Study:
NCT07314866
Study Brief:
Protocol Section:
NCT07314866