Botox for Treatment of TMJ Disorder With Bruxism
Withdrawn before enrolling · Phase 1 · Has a placebo group
Conditions studied: Temporomandibular Joint Disorders, Bruxism, Temporomandibular Joint Dysfunction Syndrome, Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint
In brief
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
Key facts
- Study ID
- NCT02202070
- Run by
- Washington University School of Medicine
- People needed
- 0
- Starts
- 2015-01-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2018-01-23
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- aged 18-65 persons with a diagnosis of myofascial temporomandibular joint disorder refractory to conservative treatment for 6 months
You may not qualify if…
- 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
Where it is running
- Washington University School of Medicine — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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