Comparison of Temporomandibular Joint Arthroscopy With Botulinum Toxin Injection Versus Placebo
Condition: Temporomandibular Joint Disorders
MeSH terms: Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      There are several studies that have considered Botulinum toxin A (BoNT-A) injections are
      effective in treating symptoms for Temporomandibular Joint (TMJ) disorders. BoNT-A injections
      improve the hyper-tonicity of mandibular muscles and its consequent joint load reduction.
      Also injections of BoNT-A, for patients with articular disc displacement, resulted in pain
      relief and return of the normal movements of the mandible. The main goal of this study is to
      test the beneficial impact of BoNT-A injections in the masticatory muscles of patients
      submitted to TMJ surgical arthroscopy.
    

Detailed description: 
      Study Objective:

      To investigate the potential performance of incobotulinumtoxin-A (BTXA) in patients submitted
      to TMJ surgical arthroscopy. Besides the acceptable good outcomes of TMJ arthroscopy, the
      authors believe that using a single injection of BTXA into the temporalis and masseter
      muscles could reduce joint loading and pain, improving TMJ arthroscopy results.

      The proposed explanation for this study:

      TMJ arthroscopy is a minimal invasive surgical technique for different types of
      temporomandibular joint (TMJ) internal derangements. Besides the acceptable outcomes of TMJ
      arthroscopy, the authors believe that adding to this treatment a single injection of BTXA
      into the temporalis and masseter muscles could reduce joint loading, improving TMJ
      arthroscopic results.
    

Intervention name(s): Incobotulinumoxin A; TMJ surgical arthroscopy
Intervention type(s): Drug; Procedure
Intervention description(s): XEOMIN® (incobotulinumtoxinA) is an approved medication that inhibits the release of acetylcholine and muscle blockage. Xeomin is indicated for the symptomatic treatment of blepharospasm and hemifacial spasm, cervical dystonia of a predominantly rotational type (spasmodic torticollis), spasticity of the upper limbs and chronic sialorrhea due to neurological changes. Xeomin comes as a white powder for solution for injection. When dissolved Xeomin is a clear, colorless solution that does not contain particles. Xeomin is reconstituted before use with sterile sodium chloride 9 mg / ml (0.9%) solution, without preservatives, for injections.
The active substance is Clostridium botulinum type A neurotoxin (150 kD), without complexing proteins. The other components are human albumin and sucrose.; TMJ arthroscopy is a minimal invasive surgical technique for different types of temporomandibular joint (TMJ) internal derangements. Besides the acceptable outcomes of TMJ arthroscopy, the authors believe that adding to this treatment a single injection of BTXA into the temporalis and masseter muscles could reduce joint loading, improving TMJ arthroscopic results.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: For this randomized clinical trial an appropriate number of sealed envelopes will be prepared: 15 for placebo and 15 for the treated group. Patients with inclusion criteria will be seen in an orofacial pain session and assessed for pain using the VAS scale, by scoring the degree of pain between 0 (absence of pain) and 10 (maximum pain). Then the patients are proposed for TMJ arthroscopy. The nurse enters the room with the patient and asks to the patient to choose an envelope. In this moment, the envelope is placed on a table and the patient writes his name. The nurse accompanies the patient to the doctor's office. Alone, the nurse opens the envelope and sees the code and the indication of PLACEBO or BTXA. Then, she will prepare in her room, isolated from the whole team, 2 syringes. She will put the envelope in a bag and deliver a tray with 2 syringes for treatment and a code to identify the patient in the treatment room. The doctor injects the syringes according to the protocol.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: IncobotulinumoxinA; Temporomandibular Joint Disorder; Temporomandibular Joint arthroscopy; Randomized clinical trial