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
Phase:
Phase 1
Details
Lead Sponsor:
Washington University School of Medicine
Treatments:
abobotulinumtoxinA Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA