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Outcomes of Bilateral Temporomandibular Joint Arthroscopy and the Role of a Second Intervention - Timings and Results

Primary Purpose

Bilateral Temporomandibular Joint Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
bilateral temporomandibular joint arthroscopy
Xeomin® (Merz)
Sponsored by
Instituto Portugues da Face
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bilateral Temporomandibular Joint Disorder focused on measuring Temporomandibular joint, TMJ arthroscopy, TMJ surgery

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age >16 years;
  • clinical diagnosis of bilateral intra-articular disorder;
  • clinical criteria for bilateral TMJ arthroscopy;
  • magnetic resonance imaging (MRI) assessing the intra-articular derangement

Exclusion Criteria:

  • The exclusion criteria included any history of previous TMJ surgical intervention or any facial trauma within the last 4 weeks prior the study.
  • Severe medical problems or mental illness, and pregnancy were also exclusion criteria

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    bilateral temporomandibular joint arthroscopy

    Arm Description

    Outcomes

    Primary Outcome Measures

    Pain (Visual Analogue Scale (0,10)
    VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain
    Pain (Visual Analogue Scale (0,10)
    VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain

    Secondary Outcome Measures

    Maximum mouth opening (MMO, mm)
    Mouth opening measured with a ruler (mm)
    Maximum mouth opening (MMO, mm)
    Mouth opening measured with a ruler (mm)
    Muscle tenderness (0-3 scale)
    0-3, corresponding to a muscle tenderness scale in masseter and temporalis muscle (0-whithout muscle tenderness, 3 - maximum muscle tenderness)
    Muscle tenderness (0-3 scale)
    0-3, corresponding to a muscle tenderness scale in masseter and temporalis muscle (0-whithout muscle tenderness, 3 - maximum muscle tenderness)

    Full Information

    First Posted
    August 24, 2021
    Last Updated
    September 8, 2021
    Sponsor
    Instituto Portugues da Face
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05027243
    Brief Title
    Outcomes of Bilateral Temporomandibular Joint Arthroscopy and the Role of a Second Intervention - Timings and Results
    Official Title
    Outcomes of Bilateral Temporomandibular Joint Arthroscopy and the Role of a Second Intervention - Timings and Results
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2, 2016 (Actual)
    Primary Completion Date
    June 26, 2021 (Actual)
    Study Completion Date
    July 31, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Instituto Portugues da Face

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Temporomandibular joint (TMJ) arthroscopy has been used successfully for intra-articular disorders. Until now, limited studies are available regarding the clinical evidence of bilateral TMJ arthroscopy for Dimitroulis 2-3. This prospective study investigated the efficacy of TMJ arthroscopy in patients with bilateral disorders, and also the need for a posterior surgery.
    Detailed Description
    Temporomandibular joint (TMJ) arthroscopy has been used successfully for intra-articular disorders. It was first introduced by Onishi at 1975, as a pioneering technique to treat painful joints and has been associated with a reduction in the number of open joints surgeries. This minimally invasive technique allows observation of the TMJ upper compartment tissues, and sometimes the lower compartment. Moreover, this intervention allows joint lysis and lavage (level 1 arthroscopy) and intra-articular surgical procedures (level 2-3 arthroscopy). Recent studies updated that TMJ arthroscopy promotes a reduction in pain and inflammatory process and restoring the mandibular function with low morbidity. Moreover, TMJ arthroscopy seems to be also long-term effective for relieving TMJ symptoms. Until now, limited studies are available regarding the clinical evidence of bilateral TMJ arthroscopy for Dimitroulis 2-3. This prospective study investigated the efficacy of TMJ arthroscopy in patients with bilateral disorders, and also the need for a posterior surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bilateral Temporomandibular Joint Disorder
    Keywords
    Temporomandibular joint, TMJ arthroscopy, TMJ surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Prospective study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    bilateral temporomandibular joint arthroscopy
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    bilateral temporomandibular joint arthroscopy
    Intervention Description
    The TMJ arthroscopy was performed with a 1.9-mm arthroscope including a video system, with a 2.8-mm outer protective cannula. Briefly, for TMJ arthroscopy level 1, the authors used the classic puncture with an entry point 10 mm anterior and 2 mm below the Holmlund-Hellsing (H-H) line. A second puncture with a 21-G needle was performed 30 mm anterior and 7 mm below the H-H line to wash the joint with 250-300 ml Ringer solution. After washing the joint, 1.5-2 cc of hyaluronic acid was injected into it. For level 2 TMJ arthroscopy, the second puncture was substituted by a 2.8-mm outer protective cannula with a sharp trocar until the joint was reached. The 2.8-mm cannula was used for (1) intra-articular coblation and/or (2) intrasynovial medication. Antibiotic and non-steroidal anti-inflammatory drugs were routinely prescribed. Patients were instructed to follow a soft diet for 3 days after surgery and 5 physiotherapy and 3 speech therapy exercise sessions after intervention.
    Intervention Type
    Drug
    Intervention Name(s)
    Xeomin® (Merz)
    Intervention Description
    For tenderness grade 2, 155U of Incobotulinum toxin A was injected in the masticatory muscles and for tenderness grade 3 195U of Incobotulinum toxin A was injected. The authors used Xeomin® (Merz) in all patients.
    Primary Outcome Measure Information:
    Title
    Pain (Visual Analogue Scale (0,10)
    Description
    VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain
    Time Frame
    Pre-surgery
    Title
    Pain (Visual Analogue Scale (0,10)
    Description
    VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain
    Time Frame
    Through study completion, an average of 2.5 years
    Secondary Outcome Measure Information:
    Title
    Maximum mouth opening (MMO, mm)
    Description
    Mouth opening measured with a ruler (mm)
    Time Frame
    Pre-surgery
    Title
    Maximum mouth opening (MMO, mm)
    Description
    Mouth opening measured with a ruler (mm)
    Time Frame
    Through study completion, an average of 2.5 years
    Title
    Muscle tenderness (0-3 scale)
    Description
    0-3, corresponding to a muscle tenderness scale in masseter and temporalis muscle (0-whithout muscle tenderness, 3 - maximum muscle tenderness)
    Time Frame
    Pre-surgery
    Title
    Muscle tenderness (0-3 scale)
    Description
    0-3, corresponding to a muscle tenderness scale in masseter and temporalis muscle (0-whithout muscle tenderness, 3 - maximum muscle tenderness)
    Time Frame
    Through study completion, an average of 2.5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age >16 years; clinical diagnosis of bilateral intra-articular disorder; clinical criteria for bilateral TMJ arthroscopy; magnetic resonance imaging (MRI) assessing the intra-articular derangement Exclusion Criteria: The exclusion criteria included any history of previous TMJ surgical intervention or any facial trauma within the last 4 weeks prior the study. Severe medical problems or mental illness, and pregnancy were also exclusion criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Ângelo, MD, PhD
    Organizational Affiliation
    Instituto Português da Face
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Outcomes of Bilateral Temporomandibular Joint Arthroscopy and the Role of a Second Intervention - Timings and Results

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