drugset / Trial / NCT04794504

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

NCT04794504 ↗

Phase 2 Unknown 64 enrolled Kingsway Oral & Maxillofacial Surgery
RandomizedParallel-groupTriple-blindSupportive care

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.

Timeline

Start
2021-04-19
Primary completion
2022-04-19
Completion
2026-04-19

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 100 iu Intramuscular

Indications