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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bilateral Temporomandibular Joint Disorder

Intervention / Treatment
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* Procedure: bilateral temporomandibular joint arthroscopy
* Drug: Xeomin® (Merz)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bilateral temporomandibular joint arthroscopy<br> | Procedure: bilateral temporomandibular joint arthroscopy<br>* 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.<br>Drug: Xeomin® (Merz)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (Visual Analogue Scale (0,10) | VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain | Pre-surgery | 
| Pain (Visual Analogue Scale (0,10) | VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain | Through study completion, an average of 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum mouth opening (MMO, mm) | Mouth opening measured with a ruler (mm) | Pre-surgery | 
| Maximum mouth opening (MMO, mm) | Mouth opening measured with a ruler (mm) | Through study completion, an average of 2.5 years | 
| 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) | Pre-surgery | 
| 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) | Through study completion, an average of 2.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Temporomandibular joint, TMJ arthroscopy, TMJ surgery