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

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

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.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Joint Disorders
• Intervention / Treatment: Procedure: TMJ surgical arthroscopy; Drug: Incobotulinumoxin A

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• Portugal
  • Lisboa, Portugal, 1050-227
    • Instituto Português da Face

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 56 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 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).	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.
Active Comparator: IncobotulinumoxinA; 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.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Palpable joint click	Yes or No	5 weeks after injection and TMJ arthroscopy
Diet consistency tolerated	regular diet, basic diet, liquid diet	5 weeks after injection and TMJ arthroscopy
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
Maximum Mouth Opening	in cm	5 weeks after injection and TMJ arthroscopy
GICS	Global Impression of change by the subject	5 weeks after injection and TMJ arthroscopy

Collaborators and Investigators

• Sponsor: Instituto Portugues da Face

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2022
• Last Update Submitted That Met QC Criteria: October 20, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Randomized clinical trial; IncobotulinumoxinA; Temporomandibular Joint Disorder; Temporomandibular Joint arthroscopy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: Eudrac: 2020-005610-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: A study Protocol and clinical study report will be avaiable in the end of the study.
• IPD Sharing Time Frame: At the moment it is not possible to predict
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No