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

NCT04794504 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: CCF2021248417
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Investigating a role of Botox intramuscular injection in reducing postoperative pain scores in orthognathic surgery patients 2 and 6 weeks after surgery

  At a two week endpoint postoperatively, orthognathic surgery patients will be asked to submit the results of the 2-week numerical rating scale questionnaire. The numerical rating scale will be administered from 0 to 10 (integer values only), with 0 representing no pain, and 10 representing the most severe pain. Co-investigators will gather this data, and the blinding protocol will be broken after the final participant submits their questionnaire to assign patients into their appropriate groups for analysis. Pain score trends between the Botox® and saline groups will be compared on a day-to-day basis, with potential use of area under curve analysis to get a scope of the overall pain scores over the 14 day postoperative period. Single pain scores at a 6 week follow-up appointment will also be collected.

  Analysis of this outcome will be ongoing throughout the study duration, and will end with the final orthognathic surgery patient completing their 2 week pain assessment

Secondary Outcomes (3)

• Investigating a role of Botox intramuscular injection in reducing postoperative muscle spams orthognathic surgery patients 2 weeks after surgery

  Analysis of this outcome will be ongoing throughout the study duration, and will end with the final orthognathic surgery patient completing their 6 week pain assessment

• Investigating a role of Botox intramuscular injection in reducing hardware failure and rates of infection 5 years postoperatively

  Analysis of this outcome will be ongoing throughout the study duration, and will end 5 years from the final participants day of surgery

• Investigating a role of Botox intramuscular injection in reducing postoperative pain scores in orthognathic surgery patients 6 weeks after surgery

  Analysis of this outcome will be ongoing throughout the study duration, and will end with the final orthognathic surgery patient completing their 6 week pain assessment

Study Arms (2)

Botox Injection Group

EXPERIMENTAL

Two weeks pre-operatively, patients in the Botox injection group will receive intramuscular injections of Botox totaling 100U bilaterally (50U/side). 10 U will be injected into the temporalis (over 5 sites) and 40 U will be injected into the masseter muscle (over 4 sites). Botox will be reconstituted from a powdered form in 2cc of 0.9% sterile saline, and appropriate volumes will be administered.

Drug: Botox 100 UNT Injection

Saline Injection Group

PLACEBO COMPARATOR

Two weeks pre-operatively, patients in the saline injection group will receive intramuscular injections of Botox totaling the same volumes administered for Botox patients above, across the same number of sites in the temporalis and masseter muscles bilaterally.

Other: 0.9% Saline Injection

Interventions

Botox 100 UNT Injection DRUG

Botox will be injected intramuscularly into the masseter and temporalis muscles bilaterally to investigate if it can supplement postoperative analgesia in orthognathic surgery patients

Also known as: OnabotulinumtoxinA

Botox Injection Group

0.9% Saline Injection OTHER

As a placebo control to the 100 UNT Botox injection, 0.9% saline will be injected intramuscularly into the masseter and temporalis muscles bilaterally

Saline Injection Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kingsway Oral & Maxillofacial Surgery: lead

Related Publications (13)

• Scaglione F. Conversion Ratio between Botox(R), Dysport(R), and Xeomin(R) in Clinical Practice. Toxins (Basel). 2016 Mar 4;8(3):65. doi: 10.3390/toxins8030065.

  PMID: 26959061 BACKGROUND

• Patel AA, Lerner MZ, Blitzer A. IncobotulinumtoxinA Injection for Temporomandibular Joint Disorder. Ann Otol Rhinol Laryngol. 2017 Apr;126(4):328-333. doi: 10.1177/0003489417693013. Epub 2017 Feb 1.

  PMID: 28290229 BACKGROUND

• Naran S, Steinbacher DM, Taylor JA. Current Concepts in Orthognathic Surgery. Plast Reconstr Surg. 2018 Jun;141(6):925e-936e. doi: 10.1097/PRS.0000000000004438.

  PMID: 29794714 BACKGROUND

• Phillips C, Blakey G 3rd, Jaskolka M. Recovery after orthognathic surgery: short-term health-related quality of life outcomes. J Oral Maxillofac Surg. 2008 Oct;66(10):2110-5. doi: 10.1016/j.joms.2008.06.080.

  PMID: 18848110 BACKGROUND

• Raschke GF, Meissner W, Peisker A, Djedovic G, Rieger U, Guentsch A, Dammeier MG, Schultze-Mosgau S. Bilateral sagittal split osteotomy-parameters and correlations of postoperative pain management. Clin Oral Investig. 2018 Jan;22(1):181-187. doi: 10.1007/s00784-017-2097-z. Epub 2017 Mar 14.

  PMID: 28293792 BACKGROUND

• Walker TJ, Dayan SH. Comparison and overview of currently available neurotoxins. J Clin Aesthet Dermatol. 2014 Feb;7(2):31-9.

  PMID: 24587850 BACKGROUND

• Dodick DW, Turkel CC, DeGryse RE, Aurora SK, Silberstein SD, Lipton RB, Diener HC, Brin MF; PREEMPT Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program. Headache. 2010 Jun;50(6):921-36. doi: 10.1111/j.1526-4610.2010.01678.x. Epub 2010 May 7.

  PMID: 20487038 BACKGROUND

• Kwon KH, Shin KS, Yeon SH, Kwon DG. Application of botulinum toxin in maxillofacial field: part I. Bruxism and square jaw. Maxillofac Plast Reconstr Surg. 2019 Oct 1;41(1):38. doi: 10.1186/s40902-019-0218-0. eCollection 2019 Dec.

  PMID: 31649901 BACKGROUND

• Mimeh H, Fenech Magrin AM, Myers S, Ghanem AM. A Critical Review of Botulinum Toxin Type A in the Prophylactic Treatment of Chronic Migraine in Adults. Aesthet Surg J. 2019 Jul 12;39(8):898-907. doi: 10.1093/asj/sjy224.

  PMID: 30184084 BACKGROUND

• Khalifeh M, Mehta K, Varguise N, Suarez-Durall P, Enciso R. Botulinum toxin type A for the treatment of head and neck chronic myofascial pain syndrome: A systematic review and meta-analysis. J Am Dent Assoc. 2016 Dec;147(12):959-973.e1. doi: 10.1016/j.adaj.2016.08.022. Epub 2016 Oct 10.

  PMID: 27737756 BACKGROUND

• Machado D, Martimbianco ALC, Bussadori SK, Pacheco RL, Riera R, Santos EM. Botulinum Toxin Type A for Painful Temporomandibular Disorders: Systematic Review and Meta-Analysis. J Pain. 2020 Mar-Apr;21(3-4):281-293. doi: 10.1016/j.jpain.2019.08.011. Epub 2019 Sep 9.

  PMID: 31513934 BACKGROUND

• Dressler D, Saberi FA, Kollewe K, Schrader C. Safety aspects of incobotulinumtoxinA high-dose therapy. J Neural Transm (Vienna). 2015 Feb;122(2):327-33. doi: 10.1007/s00702-014-1252-9. Epub 2014 Jul 17.

  PMID: 25030362 BACKGROUND

• Yeh YT, Peng JH, Peng HP. Literature review of the adverse events associated with botulinum toxin injection for the masseter muscle hypertrophy. J Cosmet Dermatol. 2018 Oct;17(5):675-687. doi: 10.1111/jocd.12721. Epub 2018 Aug 9.

  PMID: 30091170 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Kevin E Lung, DDS

CONTACT

7804546565; k.lung@kingswayos.com

Matthew Fay, DDS

CONTACT

7804546565; mfay@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All sponsors and collaborators will be blinded, and randomization and mixing of solutions will be done by an assistant not involved in the study. Half way through the study, one of the members of the research team will be unblinded to ensure confounders are appropriately matched in each of the two arms.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will have two independent groups, one receiving botox injection, and another receiving saline injection.

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 12, 2021
• Study Start: April 19, 2021
• Primary Completion: April 19, 2022
• Study Completion: April 19, 2026
• Last Updated: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share