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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT06640218
Eligibility Criteria:
Inclusion Criteria:
* Age range is from 18 to 40 years old.
* No sex predilection
* Patients seeking root canal treatment.
* restorable teeth.
* Positive patient acceptance for participating in the study.
* patients able to sign informed consent.
* Systematically healthy patient (ASA I, Il).
* Patient who can understand the numerical rate scale and sign an informed consent.
* Mandibular first molar teeth with pain on bite or percussion
* Preoperative sharp (moderate or severe) pain.
* Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).
* widening in periodontal membrane space in radiographic appearance.
Exclusion Criteria:
* Patients with American Association of Anesthesiologists (ASA) classifications other than ASA 1 \& Il
* Patients who have already ingested preoperative medication, such as analgesics, non-steroidal, or steroidal anti-inflammatory drugs, within 12 hours of the start of treatment.
* This was done to prevent any misinterpretation of the diagnosis or post-treatment pain severity, as these drugs substantially lower post-endodontic pain (Jorge-Arajo et al.,2018).
* Patients with NSAID allergy.
* Patients having two or more adjacent teeth needing root canal therapy
* Pregnant patients.
* Patients with bleeding disorder.
* Patients with long-term corticosteroid use.
* Teeth having:
* Necrotic pulp.
* History or presence of swelling or fistulous tract.
* Acute/chronic periapical abscess.
* Mobility more than grade 1.
* Pocket depth of more than 5mm
* No possible restorability.
* Previous root canal treatment.
* Periapical radiolucency.
* External or internal resorption
* Vertical root fracture.
* TMJ problems, bruxism, clenching or traumatic occlusion.
* Inability to understand and perform the given instructions.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT06640218
Study Brief:
Protocol Section:
NCT06640218