Efficacy of Botulinum Toxin in Temporomandibular Disorders
Condition: Temporomandibular Joint Disorder Bilateral
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Joint Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

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
    

Detailed 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.
    

Intervention name(s): Botulinum toxin type A injection
Intervention type(s): Drug
Intervention description(s): The solution for injection was prepared immediately before the intervention, by dissolving the vials of BTX, kept refrigerated at 5ºC, in 1 ml of sterile saline solution at room temperature. Eight injection sites were marked, three located in the masseter muscle, two in the lateral pterygoid muscle, one in the temporomandibular joint (TMJ) and two in the temporalis muscle. A 1 cc marked insulin syringe was used for intramuscular injection of the prepared solution, according to the locations and amounts proposed by Kim et al. and Ho et al. with a total dose of 100 U in each patient.distributed at the different injection sites.
Other intervention name(s): Botox® 100 U, Allergan Pharmaceuticals Westport, Ireland
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Single Group Assignment
Intervention model description: clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Botulinum toxin; Temporomandibular joint disorders; Masticatory disfunction syndrome; Randomized clinical trial