Trials / Completed
CompletedNCT05027243
Outcomes of Bilateral Temporomandibular Joint Arthroscopy and the Role of a Second Intervention - Timings and Results
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Instituto Portugues da Face · Academic / Other
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | 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. |
| DRUG | 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. |
Timeline
- Start date
- 2016-01-02
- Primary completion
- 2021-06-26
- Completion
- 2021-07-31
- First posted
- 2021-08-30
- Last updated
- 2021-09-16
Source: ClinicalTrials.gov record NCT05027243. Inclusion in this directory is not an endorsement.