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:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT06081335
Eligibility Criteria:
Inclusion Criteria:
* Single rooted mandibular second premolar teeth with complete root formation
* Pulpal diagnosis: Symptomatic irreversible pulpitis
* Periapical diagnosis: symptomatic apical periodontitis with no visible periapical radiolucent area
* Patients with pre-operative pain records above 4 on Numerical Rating Scale (NRS) to ensure standardization
Exclusion Criteria:
1. The presence of any systemic disease or allergic reactions
2. Pregnant and lactating females
3. Patients on antibiotic or anti-inflammatory medication
4. Use of analgesics a week prior to treatment
5. A radiographically untraceable canal or an excessively curved root
6. The presence of periapical radiolucency or sinus tract.
7. Teeth with open apices
8. Severe periodontal disease (generalized or localized to the tooth in question)
9. Absence of bleeding in the pulp chamber on access cavity preparation
10. Internal or external resorption
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT06081335
Study Brief:
Protocol Section:
NCT06081335