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

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ClinicalTrials.gov Identifier: NCT04810429
Recruitment Status : Recruiting
First Posted : March 23, 2021
Last Update Posted : March 23, 2021
Sponsor:
Information provided by (Responsible Party):
Instituto Portugues da Face

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.

Condition or disease Intervention/treatment Phase
Temporomandibular Joint Disorders Drug: Incobotulinumoxin A Procedure: TMJ surgical arthroscopy Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Investigator)
Masking Description: atients 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
Official Title: Comparison of Temporomandibular Joint Arthroscopy With Botulinum Toxin Injection Versus Placebo: a Randomized Clinical Trial
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04810429


Locations
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Portugal
Instituto Português da Face Recruiting
Lisboa, Portugal, 1050-227
Contact: David Ângelo, PhD, MD    +351214412544    david.angelo@ipface.pt   
Contact: Henrique Cardoso, PhD    +351214412544    henrique.cardoso@ipface.pt   
Principal Investigator: David Ângelo, MD, PhD         
Sub-Investigator: David Sanz, MD         
Sub-Investigator: Henrique Cardoso, PhD         
Sub-Investigator: Adriana Santos, BsC         
Sponsors and Collaborators
Instituto Portugues da Face
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Responsible Party: Instituto Portugues da Face
ClinicalTrials.gov Identifier: NCT04810429    
Other Study ID Numbers: Eudrac: 2020-005610-18
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A study Protocol and clinical study report will be avaiable in the end of the study.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: At the moment it is not possible to predict

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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
Keywords provided by Instituto Portugues da Face:
IncobotulinumoxinA
Temporomandibular Joint Disorder
Temporomandibular Joint arthroscopy
Randomized clinical trial
Additional relevant MeSH terms:
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Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes