Status:
NOT_YET_RECRUITING
Investigating Temporalis and Masseter Botox Injection Before Orthognathic Surgery to Improve Postoperative Pain
Lead Sponsor:
Kingsway Oral & Maxillofacial Surgery
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Jaw surgery has become a very successful way to improve the appearance and functional needs of patients. Like any surgery, jaw surgery comes with a host of possible issues that patients may experience...
Detailed Description
Background and Rationale: Dentofacial deformities in the maxillofacial skeleton often require surgical intervention to correct aesthetic and functional deficiencies (Naran, Steinbacher, and Taylor, 20...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 19 2026
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04794504
Start Date
April 19 2021
End Date
April 19 2026
Last Update
March 12 2021
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