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 @ 4:38 PM
Ignite Modification Date:
2025-12-24 @ 4:38 PM
NCT ID:
NCT06852066
Eligibility Criteria:
Inclusion Criteria:
Participants must meet all of the following criteria to be included in the study:
* Must be between 18 and 40 years old
* Must have bilaterally impacted mandibular third molars with bone retention
* Impacted teeth must be at a mesioangular angle, classified as Class 1-2 and A--B type (Pell \& Gregory classification)
* Must have an impacted tooth difficulty level of 3-5 according to the Pederson Difficulty Index
* Must be classified as ASA 1 (healthy individuals with no systemic diseases)
* Must be able to read and understand questionnaire forms and provide informed consent Must voluntarily agree to participate in the study and sign the informed consent form
Exclusion Criteria:
Participants will be excluded from the study if they meet any of the following criteria:
* Presence of any systemic disease (e.g., cardiovascular disease, liver disease, hematologic disorders, neoplastic diseases, rheumatic conditions, diabetes mellitus)
* History of psychiatric disorders or current use of anxiolytics, antidepressants, or anticonvulsants
* Use of anti-inflammatory, analgesic, or anxiolytic medications prior to the procedure that could affect pain, inflammation, or anxiety responses
* Chronic medication use, including antihistamines, NSAIDs, steroids, or antidepressants
* Presence of oral pathologies affecting pain perception (e.g., pulpitis, periodontitis, oral ulcers, cysts, or tumors)
* Suspected or confirmed pregnancy or breastfeeding
* Allergy to the local anesthetic (articaine) used in the study
* Hearing impairment that could interfere with study participation
* Presence of dentophobia (severe dental phobia)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT06852066
Study Brief:
Protocol Section:
NCT06852066