Comparison of Temporomandibular Joint Arthroscopy With Botulinum Toxin Injection Versus Placebo
- Conditions
- Temporomandibular Joint Disorders
- Interventions
- Drug: Incobotulinumoxin AProcedure: TMJ surgical arthroscopy
- Registration Number
- NCT04810429
- Lead Sponsor
- Instituto Portugues da Face
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- Patients with TMJ with indication for arthroscopy
- Age between 12-60 years old
- Minimum level of pain for inclusion should be 5/10 (on a 0-10 VAS scale)
- Previous treatment to TMD
- Previous use of facial Botulinum Toxin
- Any contraindication for the use of BTXA according to XEOMIN SmPC
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IncobotulinumoxinA TMJ surgical arthroscopy TMJ arthroscopy and Dose of IncobotulinumoxinA to be injected 100 U distributed in 2 syringes with 1 ml each: 25U (0.5ml) in Right Masseter / 25U (0.5ml) in Left Masseter / 25U (0.5ml) in Right Temporalis / 25U in Left Temporalis. Placebo TMJ surgical arthroscopy TMJ arthroscopy and Saline solution NaCl 0,9% in 2 syringes with 1 ml each. Injected in Right Masseter (0.5ml), Left Masseter (0.5ml), Right Temporalis (0.5ml) and Left Temporalis (0.5ml). IncobotulinumoxinA Incobotulinumoxin A TMJ arthroscopy and Dose of IncobotulinumoxinA to be injected 100 U distributed in 2 syringes with 1 ml each: 25U (0.5ml) in Right Masseter / 25U (0.5ml) in Left Masseter / 25U (0.5ml) in Right Temporalis / 25U in Left Temporalis.
- Primary Outcome Measures
Name Time Method VAS score 5 weeks after injection and TMJ arthroscopy Improvement in TMJ pain: measured by the patient using a Visual Analogue scale (VAS), with a range from 0 to 10, with 0 being no pain and 10 having maximum unbearable pain. VAS score will be measured every week before surgery and in the fifth week after surgery.
- Secondary Outcome Measures
Name Time Method Maximum Mouth Opening 5 weeks after injection and TMJ arthroscopy in cm
Muscle Tenderness 5 weeks after injection and TMJ arthroscopy Masseter muscle, temporalis muscle, temporalis tendon, and lateral capsule of the TMJ) - Muscle sensitivity scale (0-3)
GICS 5 weeks after injection and TMJ arthroscopy Global Impression of change by the subject
Palpable joint click 5 weeks after injection and TMJ arthroscopy Yes or No
Diet consistency tolerated 5 weeks after injection and TMJ arthroscopy regular diet, basic diet, liquid diet
Trial Locations
- Locations (1)
Instituto Português da Face
🇵🇹Lisboa, Portugal