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Botox for Treatment of TMJ Disorder With Bruxism (TMJ)

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ClinicalTrials.gov Identifier: NCT02202070
Recruitment Status : Withdrawn (Funding)
First Posted : July 28, 2014
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Ethan Baughman, Washington University School of Medicine

Brief Summary:

Hypothesis: Myofascial temporomandibular joint disorder and related symptoms are associated with mandibular condyle and temporal fossa overloading secondary to temporalis and masseter muscle hyperactivity and spasm

This study will examine the use of onabotulinumtoxinA (Botox) to treat myofascial pain disorder in patients with bruxism who frequently exhibit signs of temporomandibular joint disorder (TMD) in a double blind cross-over randomized clinical trial by injecting 50 units Botox in temporalis and masseter muscles in 32 patients with 6 months follow up.

The objective of the proposed study will be to establish the safety and efficacy of botox in treating TMD associated with bruxism. By the time patients reach the specialists office, most have failed maximal conservative therapies, including non-chew diet, night guard, oral analgesics, muscle relaxants, physical therapy, and a portion have even undergone more invasive procedures, such as manipulation under anesthesia, arthroscopy, and arthroplasty surgeries with limited improvement or recurrence. Primary outcome of the study will be 50% reduction in pain. Secondary outcomes will be 50% reduction in surgical therapy, 25% increase in maximal inter-incisal opening (MIO). The investigators look forward to working with you on the proposed study


Condition or disease Intervention/treatment Phase
Temporomandibular Joint Disorders Bruxism Temporomandibular Joint Dysfunction Syndrome Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint Drug: onabotulinumtoxinA Phase 1

Detailed Description:
The study will enroll 32 patients with myofascial TMD. Patient will be aged 18-65. Exclusion criteria will include neuromuscular diseases, prior botox injections within previous 12 months, pregnancy, and fibromyalgia. All patients will be selected from the outpatient clinic, complaining of TMJ disease associated with bruxism. Screening will include a thorough history and exam, and TMJ CT scan or MRI. Patients with neuromuscular disorders, musculoskeletal disorders, and prior Botox injections will be excluded. Patients who have not already undergone conservative treatment will be managed with 3 months conservative therapies prior to becoming eligible. All patients will be informed and consented for participation in the study and Botox injections. Baseline pain questionnaire, physical exam will be performed. Patients will be randomized to receive normal saline or botox injections. All patients will crossover for the second set of injections at 3 months. All patients will receive up to a total of 200 Botox units at either 0 or 3 month time points. In this regard, patients will act as their own placebo control. Botox will be prepared according to the manufacturer's instructions. Briefly, the lyophilized protein will be reconstituted with preservative-free normal saline and drawn into 1-mL syringe. While the patient is sitting in the office procedure chair, 25 to 50 U of Botox will be injected into each temporalis muscle and 25 to 50 U of Botox will be injected into the each masseter muscle. The patient will be instructed to keep head elevated for 8 hours. Patients will be called 3 times after the first round of injections, to monitor for adverse events. Patients will be seen in clinic at 3 months and asked to fill out a second pain questionnaire. They will also undergo second physical exam, and then receive a second set of injections (crossover). Patients will be seen in clinic at 6 months and asked to fill out a third pain questionnaire undergo third physical exam. Patients will be called 3 times after the second round of injections, to monitor for adverse events. Patients will be seen in clinic at 6 months and asked to fill out a third pain questionnaire undergo a third physical exam

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Role of Botox in Myofascial Temporomandibular Disorder
Actual Study Start Date : January 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Botox injection first, followed by placebo
50 units Botox injection in masseter and temporalis muscles in the first 3 months, then second injection of normal saline at placebo in second 3 months
Drug: onabotulinumtoxinA
Other Name: BOTOX

Experimental: Placebo injection first, followed Botox
Injection of normal saline at placebo in first 3 months, then 50 units Botox injection in masseter and temporalis muscles in the second 3 months.
Drug: onabotulinumtoxinA
Other Name: BOTOX




Primary Outcome Measures :
  1. 50% reduction in pain [ Time Frame: 6 months ]
    Patients will be seen in clinic every 3 months and asked to fill out questionaire. Questionaire will include with visual analogue scale (VAS) average pain over previous week, month


Secondary Outcome Measures :
  1. 25% increase in maximal opening at incisors [ Time Frame: 6 months ]
    Patients will be seen in clinic every 3 months. Providers will objectively measure maximal opening at incisors (MOI), lateral and anterior mandible excursion on clinical exam.


Other Outcome Measures:
  1. 50% reduction in progression of disease to surgery [ Time Frame: 6 months ]
    Patients will be monitored for TMJ arthoscopic and arthoplasty procedures



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged 18-65 persons with a diagnosis of myofascial temporomandibular joint disorder refractory to conservative treatment for 6 months

Exclusion Criteria:

  • pregnancy
  • rheumatoid arthritis
  • ankylosing spondylitis
  • psoriatic arthritis
  • fibromyalgia
  • neuropathic pain
  • pain of dental origin
  • muscle relaxant use
  • aminoglycoside use
  • prior Botox use
  • neuropathic pain
  • trigeminal neuralgia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202070


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Alan A Harvey, DMD Assistant Professor, Department of Otolaryngology

Additional Information:
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Responsible Party: Ethan Baughman, Plastic surgery resident physician, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02202070     History of Changes
Other Study ID Numbers: AAHEJB
First Posted: July 28, 2014    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Keywords provided by Ethan Baughman, Washington University School of Medicine:
onabotulinumtoxinA
Temporomandibular Joint Disorders
Bruxism
Temporomandibular Joint Dysfunction Syndrome
Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint
Additional relevant MeSH terms:
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Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Fibromyalgia
Myofascial Pain Syndromes
Bruxism
Disease
Syndrome
Pathologic Processes
Tooth Diseases
Stomatognathic Diseases
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Botulinum Toxins, Type A
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents