Comparison of Temporomandibular Joint Arthroscopy With Botulinum Toxin Injection Versus Placebo (ARTHROBTX)

Instituto Portugues da Face

Status and phase: Completed; Phase 4

Conditions: Temporomandibular Joint Disorders

Treatments: Drug: Incobotulinumoxin A; Procedure: TMJ surgical arthroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT04810429

Eudrac: 2020-005610-18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 12 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

15 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Procedure: TMJ surgical arthroscopy

IncobotulinumoxinA

Active Comparator group

Description:

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.

Treatment:

Drug: Incobotulinumoxin A

Procedure: TMJ surgical arthroscopy