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
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
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
NCT ID
NCT05027243
First Posted
August 24, 2021
Last Updated
September 8, 2021
Sponsor
Instituto Portugues da Face
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
Learn more about this trial
Outcomes of Bilateral Temporomandibular Joint Arthroscopy and the Role of a Second Intervention - Timings and Results
We'll reach out to this number within 24 hrs