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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT06679660
Eligibility Criteria:
Inclusion Criteria:
* Individuals classified as ASA 1 or ASA 2.
* Age range of 18 to 65 years.
* No known allergies to articaine or epinephrine.
* Absence of facial paresthesia.
* No use of analgesic medications within 6 hours prior to treatment.
* No use of medications, such as tricyclic antidepressants or beta blockers, that may interfere with anesthesia.
* No pathological conditions at the planned injection site.
* Periodontal pocket depth of 3 mm or less.
* Mandibular first or second premolars diagnosed with symptomatic irreversible pulpitis.
* Teeth meeting Glickman's gingival health criteria upon periodontal examination.
* Radiographically closed root apex with no detectable pathology.
* Patients must be literate and able to comprehend the use of a pain scale to provide informed consent voluntarily.
Exclusion Criteria:
* Presence of systemic conditions contraindicating endodontic treatment. Age below 18 or above 65 years.
* Pregnancy.
* Documented allergy to articaine with 1:100,000 epinephrine.
* Evidence of periapical pathology or radiolucency observed in radiographs.
* Recent use of central nervous system depressants or analgesic medication within 6 hours prior to treatment.
* Absence of reported lip numbness 10 minutes following IANB or MINB injection. Presence of a large restoration on the affected tooth.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06679660
Study Brief:
Protocol Section:
NCT06679660