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 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT07245004
Eligibility Criteria:
Inclusion Criteria:
* Healthy patients aged at least 18 years old with deep or extremely deep carious lesions in mature permanent posterior teeth diagnose with symptomatic irreversible pulpitis. Diagnoses are confirmed using Electric Pulp Test(EPT) and cold test. Pulpal and periapical diagnoses are based on terminology from the American Association of Endodontists (AAE, 2013).
* Posterior teeth with moderate or severe pain according to the Visual Analog Scale(VAS):no pain(0), mild pain, non-disruptive to routine activity (1-3), moderate pain, interferes with daily life but no need analgesic intake (4-6) and severe pain, interferes with daily life and need analgesic intake (7-10).
* Teeth that response negatively to percussion and palpation tests.
* Teeth without periapical pathosis.
* Teeth are restorable with direct composite restoration.
Exclusion Criteria:
* Teeth with subgingival caries and/or clinical attachment loss more than 3 mm and probing depth more than 4 mm.
* Negative responses to pulp sensibility tests, presence of sinus tracts, swelling, non-restorable crowns, immature roots, or no pulp exposure following complete caries removal in case of pre-operative diagnosis as asymptomatic irreversible pulpitis.
* Patients with systemic diseases involving bleeding disorders such as hemophilia, Von Willebrand disease, platelet disorders. And patients under taking all kind of anticoagulant and anti-platelet.
* Patients who had taken analgesics or anti-inflammatory drugs within the previous 24 hours.
* Patients taking opioids.
* Known allergies to non-steroidal anti-inflammatory drugs (NSAIDs).
* Pregnant or lactating patients.
* Teeth with pulpal obliteration.
* Necrotic pulp is found after access opening.
* Bleed cannot be stopped within 8 minutes after full pulpotomy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07245004
Study Brief:
Protocol Section:
NCT07245004