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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT05687760
Eligibility Criteria:
Inclusion Criteria:
1. Patients who are free from any physical or mental handicapping condition with no underlying systemic disease (ASA I or II) .
2. Age between 25-50 years old.
3. Males \& Females.
4. Patients who can understand pain scale and can sign the informed consent.
5. Mandibular Single rooted premolars, having single root canal:
* Diagnosed clinically with pulp necrosis.
* Absence of spontaneous pulpal pain.
* Positive pain on percussion denoting apical periodontitis.
* Slight widening in the periodontal membrane space with or without periapical radiolucency radiographically.
* Normal occlusal contact with opposing teeth
Exclusion Criteria:
* Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients have shown higher incidence of pain and lower healing rate.
* Pregnant women: Avoid radiation exposure, anesthesia, and medication.
* If antibiotics have been administrated by the patient during the past 12 hours preoperatively might alter their pain perception.
* Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation.
* Teeth that shows association with acute periapical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain.
* Greater than grade I mobility or pocket depth greater than 5mm. Need special surgical and/or periodontal therapy.
* No restorability: Hopeless tooth.
* Immature teeth.
* Radiographic evidence of external or internal root resorption.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
50 Years
Study:
NCT05687760
Study Brief:
Protocol Section:
NCT05687760