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 @ 3:18 AM
Ignite Modification Date:
2025-12-25 @ 3:18 AM
NCT ID:
NCT07239505
Eligibility Criteria:
Inclusion Criteria:
* Systemically healthy male patients (ASA I or II)
* Aged 18 to 50 years
* Presenting with symptomatic irreversible pulpitis in a restorable mandibular molar
* Preoperative moderate to severe pain (VAS ≥45 mm)
* Normal periapical tissue (no radiolucency, pocket depth ≤5 mm, mobility ≤ Grade I)
Exclusion Criteria:
Medically compromised patients (ASA III or higher)
* History of allergy or intolerance to Trinase or any of its components (trypsin, bromelain, rutin)
* Vertical root fracture
* External or internal root resorption
* Periodontal pocket depth \>5 mm
* Tooth mobility Grade II or III
* Presence of periapical lesion (radiolucency)
* Female patients (to standardize pain perception and hormonal factors)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT07239505
Study Brief:
Protocol Section:
NCT07239505