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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05027243
Enrollment
46
Registered
2021-08-30
Start date
2016-01-02
Completion date
2021-07-31
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bilateral Temporomandibular Joint Disorder

Keywords

Temporomandibular joint, TMJ arthroscopy, TMJ surgery

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.

Interventions

PROCEDUREbilateral temporomandibular joint arthroscopy

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.

DRUGXeomin® (Merz)

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.

Sponsors

Instituto Portugues da Face
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Prospective study

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain (Visual Analogue Scale (0,10)Pre-surgeryVAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain

Secondary

MeasureTime frameDescription
Maximum mouth opening (MMO, mm)Pre-surgeryMouth opening measured with a ruler (mm)
Muscle tenderness (0-3 scale)Pre-surgery0-3, corresponding to a muscle tenderness scale in masseter and temporalis muscle (0-whithout muscle tenderness, 3 - maximum muscle tenderness)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026