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Clinical Trial Summary

Temporomandibular disorders (TMDs) represent a multifactorial pathological group that gives rise to a varied and complex symptomatology that includes decreased jaw movement, muscle and joint pain, joint crepitation and limitation or functional deviation of the jaw opening. All this is sometimes accompanied by headache and other painful symptoms in the neck musculature, incapacitating for many patients and at considerable public health expense. Intramuscular and intra-articular injections of botulinum toxin are a simple treatment that has proven to be effective in the treatment of the painful symptoms of these disorders, being a therapeutic option in situations of failure of conventional treatments, without presenting adverse effects. Our study presents the preliminary results of twenty patients treated with this therapy


Clinical Trial Description

TMDs are a common pathology affecting up to 70% of the population, with a maximum incidence in young patients. We used a sample of twenty patients recruited in the Maxillofacial Surgery Service of the University Hospital of Salamanca (Spain), who met the inclusion criteria, with unilateral painful symptomatology of more than three months duration. All patients were randomly treated by intramuscular and intra-articular injections of BTX (100 U) in 8 predetermined points. Pain symptomatology was assessed at the different locations, together with joint symptomatology, at baseline and 6 weeks after treatment. Adverse effects were also evaluated. In 85% of the patients, pain on oral opening improved and 90% showed improvement of pain on mastication. A 75% of the patients reported improvement in joint clicking/noise. Headaches improved or disappeared in 70% of the patients treated. Despite the limitations of the study and the preliminary results, intramuscular and intra-articular infiltrations with BTX were effective in the treatment of symptoms associated with TMDs, with minimal adverse effects. ;


Study Design


Related Conditions & MeSH terms

  • Disease
  • Joint Diseases
  • Temporomandibular Joint Disorder Bilateral
  • Temporomandibular Joint Disorders
  • Temporomandibular Joint Dysfunction Syndrome

NCT number NCT05651256
Study type Interventional
Source University of Salamanca
Contact
Status Completed
Phase Phase 2/Phase 3
Start date March 1, 2021
Completion date July 30, 2021

See also
  Status Clinical Trial Phase
Completed NCT04103047 - TMJ Dysfunction Following Use of SAD