Investigating Temporalis and Masseter Botox Injection Before Orthognathic Surgery to Improve Postoperative Pain

• Status: Not yet recruiting
• Trial end date: 2026-04-19
• Target enrollment: 0
• Participant gender: All

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 during their recovery. Although some of the most serious complications, like infections, have reliable ways to alleviate the symptoms, patients must endure several other discomforting factors. These include postoperative pain and muscle spasms. Botox® is becoming an increasingly used intervention to treat muscle related disorders (including temporomandibular disorders and chronic myofascial pain) in the head and beck region. The investigators believe that by injecting Botox® into the muscles surrounding the surgical area, patients may experience a relief in tension-related discomfort, leading to less pain and better jaw function during recovery from surgery. Further, the side effects of Botox® are either very minimal or exceedingly rare. Ultimately, Botox® may serve as a great alleviating factor with few downsides, and represent a supplementary approach to helping mitigate postoperative pain.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kingsway Oral & Maxillofacial Surgery
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A

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