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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT04794504
Eligibility Criteria:
Inclusion Criteria:
* All patients between the ages 18 and 65 undergoing BSSO at Kingsway Oral and Maxillofacial Surgery are eligible to participate in the study, provided they do not fit any of the exclusion criteria.
Exclusion Criteria:
-Patient with history of chronic pain conditions including, but not limited to: myofascial pain:
* TMD, internal disc derangement, and TMJ osteoarthritis
* chronic migraines/tension type headaches and cervical pain
* generalized anxiety disorder
* diagnosed neuropathic pain (neuralgias)
* Mentally incompetent individuals
* History of botulinum toxin use for cosmetic and therapeutic uses
* History of trauma or previous orthognathic surgery
* Patients with hypersensitivity to BoNT-A
* Pregnant women
* Nursing women
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04794504
Study Brief:
Protocol Section:
NCT04794504