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 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT07289633
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 years or older with adequate oral hygiene.
* Teeth with no previous endodontic or restorative treatment.
* Teeth that do not respond to cold test and electric pulp test during vitality assessment.
* Teeth that are asymptomatic prior to treatment.
* Mandibular first or second molar teeth with complete root development.
* No bleeding observed in the pulp chamber after caries removal.
* Teeth with a Periapical Index (PAI) score of 3 or less.
* Patients who have not used antibiotics within the last 1 month.
* Patients who have not used analgesics within the last 72 hours.
Exclusion Criteria:
* Presence of systemic diseases that may affect healing (e.g., uncontrolled diabetes, immunosuppression).
* Pregnancy or breastfeeding.
* Teeth with a history of trauma, resorption, or previous endodontic access.
* Teeth with root canal calcifications or anatomical abnormalities preventing standard instrumentation.
* Presence of sinus tract, swelling, or acute apical abscess.
* Teeth with a Periapical Index (PAI) score greater than 3.
* Patients taking medications that may alter pain perception (e.g., corticosteroids, neuropathic pain medications).
* Patients unable to comply with follow-up pain recordings.
* Patients with known allergy to any materials used in the study (e.g., sodium hypochlorite, sealers).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07289633
Study Brief:
Protocol Section:
NCT07289633