Clinical trial NCT04810429: Comparison of Temporomandibular Joint Arthroscopy With Botulinum Toxin Injection Versus Placebo
Official title: Comparison of Temporomandibular Joint Arthroscopy With Botulinum Toxin Injection Versus Placebo: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Temporomandibular Joint Disorders
Keywords: IncobotulinumoxinA
Temporomandibular Joint Disorder
Temporomandibular Joint arthroscopy
Randomized clinical trial
Lead sponsor: Instituto Portugues da Face
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Previous treatment to TMD
* Previous use of facial Botulinum Toxin
* Any contraindication for the use of BTXA according to XEOMIN SmPC

Primary outcomes:
measure: VAS score
timeFrame: 5 weeks after injection and TMJ arthroscopy
Secondary outcomes:
measure: Palpable joint click
timeFrame: 5 weeks after injection and TMJ arthroscopy
measure: Diet consistency tolerated
timeFrame: 5 weeks after injection and TMJ arthroscopy
measure: Muscle Tenderness
timeFrame: 5 weeks after injection and TMJ arthroscopy
measure: Maximum Mouth Opening
timeFrame: 5 weeks after injection and TMJ arthroscopy
measure: GICS
timeFrame: 5 weeks after injection and TMJ arthroscopy
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Instituto Português da Face
Study officials:
References: