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

NCT05027243 | Completed

• 1 other identifier: TMJARTHRO
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bilateral Temporomandibular Joint Disorder

Keywords

Temporomandibular joint; TMJ arthroscopy; TMJ surgery

Outcome Measures

Primary Outcomes (2)

• Pain (Visual Analogue Scale (0,10)

  VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain

  Pre-surgery

• Pain (Visual Analogue Scale (0,10)

  VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain

  Through study completion, an average of 2.5 years

Secondary Outcomes (4)

• Maximum mouth opening (MMO, mm)

  Pre-surgery

• Maximum mouth opening (MMO, mm)

  Through study completion, an average of 2.5 years

• Muscle tenderness (0-3 scale)

  Pre-surgery

• Muscle tenderness (0-3 scale)

  Through study completion, an average of 2.5 years

Study Arms (1)

bilateral temporomandibular joint arthroscopy

EXPERIMENTAL

Procedure: bilateral temporomandibular joint arthroscopy; Drug: Xeomin® (Merz)

Interventions

bilateral temporomandibular joint arthroscopy 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.

bilateral temporomandibular joint arthroscopy

Xeomin® (Merz) 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.

bilateral temporomandibular joint arthroscopy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Instituto Portugues da Face: lead

MeSH Terms

Interventions

incobotulinumtoxinA

Study Officials

• David Ângelo, MD, PhD

  Instituto Português da Face

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director

Model Details: Prospective study

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: August 30, 2021
• Study Start: January 2, 2016
• Primary Completion: June 26, 2021
• Study Completion: July 31, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share