Comparison of Temporomandibular Joint Arthroscopy With Botulinum Toxin Injection Versus Placebo

Temporomandibular Joint Disorders Clinical Trial

— ARTHROBTX  

Official title:

Comparison of Temporomandibular Joint Arthroscopy With Botulinum Toxin Injection Versus Placebo: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04810429
• Other study ID #: Eudrac: 2020-005610-18
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2022
• Source: Instituto Portugues da Face
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Drug:
• Incobotulinumoxin A
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.

Procedure:
• TMJ surgical arthroscopy
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.

Locations

Country	Name	City	State
Portugal	Instituto Português da Face	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Portugues da Face

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS score	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.	5 weeks after injection and TMJ arthroscopy
Secondary	Palpable joint click	Yes or No	5 weeks after injection and TMJ arthroscopy
Secondary	Diet consistency tolerated	regular diet, basic diet, liquid diet	5 weeks after injection and TMJ arthroscopy
Secondary	Muscle Tenderness	Masseter muscle, temporalis muscle, temporalis tendon, and lateral capsule of the TMJ) - Muscle sensitivity scale (0-3)	5 weeks after injection and TMJ arthroscopy
Secondary	Maximum Mouth Opening	in cm	5 weeks after injection and TMJ arthroscopy
Secondary	GICS	Global Impression of change by the subject	5 weeks after injection and TMJ arthroscopy