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

NCT ID: NCT05027243

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-02
• Study Completion Date: 2021-07-31

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.

Conditions

Bilateral Temporomandibular Joint Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bilateral temporomandibular joint arthroscopy

Group Type: EXPERIMENTAL

bilateral temporomandibular joint arthroscopy

Intervention Type: PROCEDURE

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.

Xeomin® (Merz)

Intervention Type: DRUG

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.

Interventions

bilateral 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.

Intervention Type: PROCEDURE

Xeomin® (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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Portugues da Face

OTHER

Sponsor Role: lead

Responsible Party

David Faustino Ângelo

Clinical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Ângelo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Português da Face

Other Identifiers

TMJARTHRO

Identifier Type: -

Identifier Source: org_study_id