Pain, PostoperativePhase 2NCT04794504
Investigating Temporalis and Masseter Botox Injection Before Orthognathic Surgery to Improve Postoperative Pain
A Phase 2 study testing Botox 100 UNT Injection and 0.9% Saline Injection in people with Pain, Postoperative, run by Kingsway Oral & Maxillofacial Surgery.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Botox 100 UNT Injection and 0.9% Saline Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 19 Apr 2021to 19 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -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
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Botulinum Toxin Type A Injected Into the Temporalis and Masseter Before Orthognathic Surgery to Improve Postoperative Pain
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.
Read the 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, 2018). Often, patients suffer a number of postoperative complications, including postoperative pain and muscle spasms (Phillips, Blakey, and Jaskolka, 2008). While post-operative analgesics are used, regimens are often unsatisfactory in their ability to alleviate patient discomfort (Raschke et al. 2018). Botulinum toxin type A variants (BoNT-A; including Botox®) are becoming an increasingly used intervention to treat muscle-related disorders in the head and neck region, including migraines, myofascial pain, and temporomandibular joint disorders (Walker \& Dayan, 2014; Dodick et al, 2010; Mimeh, Fenech, Myers, \& Ghanem, 2019; Khalifeh et al., 2016, Machado et al., 2020). This occurs by inducing a flaccid muscle paralysis, which alleviates tension-related discomfort (Kwon et al., 2019). Thus by injecting Botox® into the muscles surrounding the surgical area preoperatively, patients may experience a relief in tension-related muscle pain and better jaw function during recovery from surgery. In addition to its great safety profile, where side effects are either very minimal or exceedingly rare, Botox® may serve as a great supplemental option to current postoperative analgesic regimens (Dressler et al., 2015, Yeh et al., 2018).
Objective: The primary objective of this study is to investigate whether preoperative injection of Botox® into the temporalis and masseter in patients undergoing bilateral sagittal split osteotomies (BSSO) will improve pain scores and spasms in the immediate 2 week, as well as 6 week, postoperative periods. Additionally, patients will be followed 5 years from the time of surgery to look for indicators of relapse, including infection and hardware failure.
Research question: Can injecting Botox® into facial muscles 2 weeks prior to orthognathic surgery result in decreased pain and muscle spasms postoperatively?
Methods: The investigators plan to do a pilot study involving patients undergoing BSSO to evaluate postoperative pain scores and muscle spasms. There is a lack of evidence investigating post-operative pain management in orthognathic surgery using Botox®, thus the studies outlined in this proposal will serve as a pilot project. However, to guide sample size determination, another study investigating incobotulinumtoxinA, one of the variants of botulinum toxin with a similar potency profile to Botox® (Scaglione, 2016), was used. This product has been used as a therapeutic treatment for temporomandibular disorders to manage myofascial pain (Patel, Lerner, and Blitzer, 2017). For these studies, based on previous experiences, a pain difference of 15% was determined to be clinically significant. Assuming a normal distribution, a continuous pain outcome, with an ⍺-level of 0.05, and a power of 80%, the investigators estimate 32 patients/group will need to be enrolled to capture this difference.
This will be a double-blinded study. The patients, principal investigators and trained observers analyzing the data will be blinded to the two groups. Half of the patients will receive BoNT-A injections (Botox® Therapeutic by Allergan, Inc), with the other half receiving 0.9% normal saline injections as a control cohort. Injections for both cohorts will be done two weeks preoperatively. Patients will be randomly designated to one of the two groups by a research assistant at Kingsway Oral and Maxillofacial surgery not named to the investigative team. Patients will be randomized into two groups using a 2:2 randomized block design. A computer-generated algorithm developed the randomization sequence which allowed for allotment of each patient into either group 1 (indicating Botox® injection) or 2 (indicating saline injection). Patients will not be informed of the group they belong to, only that they will be injected with either Botox® or saline; the surgical assistants will prepare either the Botox® injection or the 0.9% normal saline injection. The injection will be given to the surgeons performing the procedures with no knowledge of which patients will be getting which injection.
BSSO will be performed by Dr. Clayton Davis, Dr. Kevin Lung, and Dr. Matt Fay according to Kinsgway Oral and Maxillofacial Surgery clinical protocols. Patients will be asked to complete a numerical response scale (NRS) daily for 14 consecutive days, starting on postoperative day 1. Each day, the highest pain rating will be recorded as a whole number on a 0-10 scale. In the same 2 week timeframe, patients will also be asked to track any muscle spasms daily in the form of a "yes/no" question. At the 6 week follow-up appointment, patients will be asked to rate their pain at the current time on the NRS, and will be asked about further muscle spasms in the 2-6 week postoperative period in the form of a "yes/no" question. In order to track pain scores and muscle spasms, a paper questionnaire will be distributed to all patients. In addition to scoring pain daily on the NRS, patients will be asked to track: the time of the most severe pain, medications that were taken to help with the pain, pain intensity 1 hour after medication was taken, location of the pain, activities that led to onset of pain, and occurrence of muscle spasms. At the 2 week follow-up appointment, patients will bring back their paper copy of the questionnaire. Hardware failure and infection will be documented in the patient's chart, and will be viewed retrospectively study 5 years from now in the form of chart reviews of all study participants.
- Conditions
- Pain, Postoperative
- Being tested
- Botox 100 UNT Injection, 0.9% Saline Injection
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox 100 UNT InjectionDrug
Also called OnabotulinumtoxinA
Botox will be injected intramuscularly into the masseter and temporalis muscles bilaterally to investigate if it can supplement postoperative analgesia in orthognathic surgery patients
0.9% Saline InjectionOther
As a placebo control to the 100 UNT Botox injection, 0.9% saline will be injected intramuscularly into the masseter and temporalis muscles bilaterally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: 0.9% Saline Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
At the 6 week follow-up appointment, patients will be asked if they experienced muscle spasms in the 2-6 week postoperative period. Answers will be collected and reported as a proportion answering "yes" and "no", comparing the botox injection and saline injection groups
Measured: 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
Five years after initiating this study, a retrospective analysis will be performed of participant's chart to note any infections or hardware failures that occurred, and if differences between the botox injection and saline injection group exist in these parameters
Measured: 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
Single pain scores on a 0-10 numerical rating scale will be collected at a 6 week follow-up appointment with 0 representing no pain, and 10 being the most severe pain.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start19 Apr 2021 (estimated)
- Primary completion19 Apr 2022 (estimated)
- Study completion19 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will have two independent groups, one receiving botox injection, and another receiving saline injection.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kingsway Oral & Maxillofacial Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794504
- Sponsor's protocol ID
- CCF2021
- Other IDs
- 248417
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be kept strictly confidential to the sponsors and scientific team appointed to this study by HREBA, and will not be distributed to other researchers.
Publications
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.
PubMed 26959061Patel 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.
PubMed 28290229Naran S, Steinbacher DM, Taylor JA. Current Concepts in Orthognathic Surgery. Plast Reconstr Surg. 2018 Jun;141(6):925e-936e. doi: 10.1097/PRS.0000000000004438.
PubMed 29794714Phillips 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.
PubMed 18848110Raschke 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.
PubMed 28293792Walker TJ, Dayan SH. Comparison and overview of currently available neurotoxins. J Clin Aesthet Dermatol. 2014 Feb;7(2):31-9.
PubMed 24587850Dodick 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.
PubMed 20487038Kwon 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.
PubMed 31649901Mimeh 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.
PubMed 30184084Khalifeh 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.
PubMed 27737756Machado 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.
PubMed 31513934Dressler 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.
PubMed 25030362Yeh 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.
PubMed 30091170
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin Type A Injected Into the Temporalis and Masseter Before Orthognathic Surgery to Improve Postoperative Pain
- ClinicalTrials.gov ID
- NCT04794504
- Acronym / sponsor ID
- CCF2021
- Conditions
- Pain, Postoperative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Kingsway Oral & Maxillofacial SurgeryUniversity, hospital or other
- Study start
- 19 Apr 2021 (estimated)
- Primary completion
- 19 Apr 2022 (estimated)
- Study completion
- 19 Apr 2026 (estimated)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 2018). Often, patients suffer a number of postoperative complications, including postoperative pain and muscle spasms (Phillips, Blakey, and Jaskolka, 2008). While post-operative analgesics are used, regimens are often unsatisfactory in their ability to alleviate patient discomfort (Raschke et al. 2018). Botulinum toxin type A variants (BoNT-A; including Botox®) are becoming an increasingly used intervention to treat muscle-related disorders in the head and neck region, including migraines, myofascial pain, and temporomandibular joint disorders (Walker \& Dayan, 2014; Dodick et al, 2010; Mimeh, Fenech, Myers, \& Ghanem, 2019; Khalifeh et al., 2016, Machado et al., 2020). This occurs by inducing a flaccid muscle paralysis, which alleviates tension-related discomfort (Kwon et al., 2019). Thus by injecting Botox® into the muscles surrounding the surgical area preoperatively, patients may experience a relief in tension-related muscle pain and better jaw function during recovery from surgery. In addition to its great safety profile, where side effects are either very minimal or exceedingly rare, Botox® may serve as a great supplemental option to current postoperative analgesic regimens (Dressler et al., 2015, Yeh et al., 2018).
Objective: The primary objective of this study is to investigate whether preoperative injection of Botox® into the temporalis and masseter in patients undergoing bilateral sagittal split osteotomies (BSSO) will improve pain scores and spasms in the immediate 2 week, as well as 6 week, postoperative periods. Additionally, patients will be followed 5 years from the time of surgery to look for indicators of relapse, including infection and hardware failure.
Research question: Can injecting Botox® into facial muscles 2 weeks prior to orthognathic surgery result in decreased pain and muscle spasms postoperatively?
Methods: The investigators plan to do a pilot study involving patients undergoing BSSO to evaluate postoperative pain scores and muscle spasms. There is a lack of evidence investigating post-operative pain management in orthognathic surgery using Botox®, thus the studies outlined in this proposal will serve as a pilot project. However, to guide sample size determination, another study investigating incobotulinumtoxinA, one of the variants of botulinum toxin with a similar potency profile to Botox® (Scaglione, 2016), was used. This product has been used as a therapeutic treatment for temporomandibular disorders to manage myofascial pain (Patel, Lerner, and Blitzer, 2017). For these studies, based on previous experiences, a pain difference of 15% was determined to be clinically significant. Assuming a normal distribution, a continuous pain outcome, with an ⍺-level of 0.05, and a power of 80%, the investigators estimate 32 patients/group will need to be enrolled to capture this difference.
This will be a double-blinded study. The patients, principal investigators and trained observers analyzing the data will be blinded to the two groups. Half of the patients will receive BoNT-A injections (Botox® Therapeutic by Allergan, Inc), with the other half receiving 0.9% normal saline injections as a control cohort. Injections for both cohorts will be done two weeks preoperatively. Patients will be randomly designated to one of the two groups by a research assistant at Kingsway Oral and Maxillofacial surgery not named to the investigative team. Patients will be randomized into two groups using a 2:2 randomized block design. A computer-generated algorithm developed the randomization sequence which allowed for allotment of each patient into either group 1 (indicating Botox® injection) or 2 (indicating saline injection). Patients will not be informed of the group they belong to, only that they will be injected with either Botox® or saline; the surgical assistants will prepare either the Botox® injection or the 0.9% normal saline injection. The injection will be given to the surgeons performing the procedures with no knowledge of which patients will be getting which injection.
BSSO will be performed by Dr. Clayton Davis, Dr. Kevin Lung, and Dr. Matt Fay according to Kinsgway Oral and Maxillofacial Surgery clinical protocols. Patients will be asked to complete a numerical response scale (NRS) daily for 14 consecutive days, starting on postoperative day 1. Each day, the highest pain rating will be recorded as a whole number on a 0-10 scale. In the same 2 week timeframe, patients will also be asked to track any muscle spasms daily in the form of a "yes/no" question. At the 6 week follow-up appointment, patients will be asked to rate their pain at the current time on the NRS, and will be asked about further muscle spasms in the 2-6 week postoperative period in the form of a "yes/no" question. In order to track pain scores and muscle spasms, a paper questionnaire will be distributed to all patients. In addition to scoring pain daily on the NRS, patients will be asked to track: the time of the most severe pain, medications that were taken to help with the pain, pain intensity 1 hour after medication was taken, location of the pain, activities that led to onset of pain, and occurrence of muscle spasms. At the 2 week follow-up appointment, patients will bring back their paper copy of the questionnaire. Hardware failure and infection will be documented in the patient's chart, and will be viewed retrospectively study 5 years from now in the form of chart reviews of all study participants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- We will have two independent groups, one receiving botox injection, and another receiving saline injection.
| Arm | Type | Receives |
|---|---|---|
| Botox Injection Group | Experimental | Drug: Botox 100 UNT InjectionTwo 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. |
| Saline Injection Group | Placebo comparator | Other: 0.9% Saline InjectionTwo 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- -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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botox 100 UNT InjectionAlso: OnabotulinumtoxinABotox will be injected intramuscularly into the masseter and temporalis muscles bilaterally to investigate if it can supplement postoperative analgesia in orthognathic surgery patients | Drug | Botox Injection Group |
| 0.9% Saline InjectionAs a placebo control to the 100 UNT Botox injection, 0.9% saline will be injected intramuscularly into the masseter and temporalis muscles bilaterally | Other | Saline Injection Group |
Primary outcome
Investigating a role of Botox intramuscular injection in reducing postoperative pain scores in orthognathic surgery patients 2 and 6 weeks after surgery
Time frame: 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
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.
3 secondary outcomes
Investigating a role of Botox intramuscular injection in reducing postoperative muscle spams orthognathic surgery patients 2 weeks after surgery
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Background: PubMed 26959061Scaglione 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.
- Background: PubMed 28290229Patel 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.
- Background: PubMed 29794714Naran S, Steinbacher DM, Taylor JA. Current Concepts in Orthognathic Surgery. Plast Reconstr Surg. 2018 Jun;141(6):925e-936e. doi: 10.1097/PRS.0000000000004438.
- Background: PubMed 18848110Phillips 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.
- Background: PubMed 28293792Raschke 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.
- Background: PubMed 24587850Walker TJ, Dayan SH. Comparison and overview of currently available neurotoxins. J Clin Aesthet Dermatol. 2014 Feb;7(2):31-9.
- Background: PubMed 20487038Dodick 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.
- Background: PubMed 31649901Kwon 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.
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- Individual participant dataSharing planned: No. IPD will be kept strictly confidential to the sponsors and scientific team appointed to this study by HREBA, and will not be distributed to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botox 100 UNT Injection and 0.9% Saline Injection in people with Pain, Postoperative, run by Kingsway Oral & Maxillofacial Surgery.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kevin E Lung, DDS (7804546565, k.lung@kingswayos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigating a role of Botox intramuscular injection in reducing postoperative pain scores in orthognathic surgery patients 2 and 6 weeks after surgery (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04794504, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2021.