Clinical trial NCT05027243: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bilateral Temporomandibular Joint Disorder
Keywords: Temporomandibular joint
TMJ arthroscopy
TMJ surgery
Lead sponsor: Instituto Portugues da Face
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 46
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain (Visual Analogue Scale (0,10)
timeFrame: Pre-surgery
measure: Pain (Visual Analogue Scale (0,10)
timeFrame: Through study completion, an average of 2.5 years
Secondary outcomes:
measure: Maximum mouth opening (MMO, mm)
timeFrame: Pre-surgery
measure: Maximum mouth opening (MMO, mm)
timeFrame: Through study completion, an average of 2.5 years
measure: Muscle tenderness (0-3 scale)
timeFrame: Pre-surgery
measure: Muscle tenderness (0-3 scale)
timeFrame: Through study completion, an average of 2.5 years
Other outcomes:
Locations:
Study officials:
affiliation: Instituto Português da Face
name: David Ângelo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: