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

Not Applicable

Completed

• Conditions: Bilateral Temporomandibular Joint Disorder
• Interventions: Procedure: bilateral temporomandibular joint arthroscopy; Drug: Xeomin® (Merz)

• Registration Number: NCT05027243
• Lead Sponsor: Instituto Portugues da Face

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.

Study Timeline

• Study Start: 2016-01-02
• Primary Completion: 2021-06-26
• Study Completion: 2021-07-31
• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-08-24
• Study First Posted: 2021-08-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bilateral temporomandibular joint arthroscopy	Xeomin® (Merz)	-
bilateral temporomandibular joint arthroscopy	bilateral temporomandibular joint arthroscopy	-

Primary Outcome Measures

Name	Time	Method
Pain (Visual Analogue Scale (0,10)	Through study completion, an average of 2.5 years	VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain

Secondary Outcome Measures

Name	Time	Method
Muscle tenderness (0-3 scale)	Through study completion, an average of 2.5 years	0-3, corresponding to a muscle tenderness scale in masseter and temporalis muscle (0-whithout muscle tenderness, 3 - maximum muscle tenderness)
Maximum mouth opening (MMO, mm)	Through study completion, an average of 2.5 years	Mouth opening measured with a ruler (mm)