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NCT Number: NCT04810429

Comparison of Temporomandibular Joint Arthroscopy With Botulinum Toxin Injection Versus Placebo

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.

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Key information

Conditions

Temporomandibular Joint Disorders Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases

Age range

12 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto Português da Face

Lisbon, 1050-227, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Incobotulinumoxin A

Drug

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 surgical arthroscopy

Procedure

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.

Primary outcomes

  1. VAS score

    Time frame: 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 outcomes

  1. Palpable joint click

    Time frame: 5 weeks after injection and TMJ arthroscopy

    Yes or No

  2. Diet consistency tolerated

    Time frame: 5 weeks after injection and TMJ arthroscopy

    regular diet, basic diet, liquid diet

  3. Muscle Tenderness

    Time frame: 5 weeks after injection and TMJ arthroscopy

    Masseter muscle, temporalis muscle, temporalis tendon, and lateral capsule of the TMJ) - Muscle sensitivity scale (0-3)

  4. Maximum Mouth Opening

    Time frame: 5 weeks after injection and TMJ arthroscopy

    in cm

  5. GICS

    Time frame: 5 weeks after injection and TMJ arthroscopy

    Global Impression of change by the subject

Sponsors and collaborators

Lead sponsor

Instituto Portugues da Face

Other

Registry information

Official study title

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

Acronym: ARTHROBTX

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 23, 2021
Registry last updated
Oct 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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