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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT05964933
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 12 years or older
* Mature permanent tooth with deep caries/restorations
* Symptoms indicative of irreversible pulpitis (moderate to severe spontaneous lingering pain)
* Tooth is responsive to cold and electric pulp test (EPT) sensibility testing
* Tooth is restorable and can be adequately isolated during treatment
* One tooth (molar or premolar) per patient.
Exclusion Criteria:
* Teeth with active periodontal disease (pocket depth \>5mm)
* Teeth indicated for elective root canal treatment for restorative purposes
* Teeth with apical periodontitis
* Patients with complex medical histories that may affect their caries experience and healing ability (immunocompromised, radiotherapy etc.)
* Patients who are unable to consent
* History of trauma to the tooth
* Presence of apical radiolucency
* Patients who are pregnant or breast-feeding
* Teeth with any evidence of purulence or excessive bleeding that cannot be controlled with a cotton pellet with 2-4% hypochlorite for 10 minutes
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT05964933
Study Brief:
Protocol Section:
NCT05964933