Clinical trial NCT06256042: Effectiveness of Arthrocentesis and the Occlusal Splint in Treatment of the TMJ
Official title: Effectiveness of Arthrocentesis and the Occlusal Splint in Treatment of Disc Displacements of the Temporomandibular Joint
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Disc Displacement
Anterior Disc Displacement
Keywords: Temporomandibular joint
Anterior disc displacement
Arthrocentesis
Interocclusal stabilizing splint.
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stabilizing interocclusal plate (IOP): a stabilizing maxillary acrylic occlusal plate was made, flat, total and adjusted in central relation (RC). Advice and guidance on the disease.

Arthrocentesis: Delimitation of a corner-tragus line to mark points A (10mm in front of the tragus and 2mm below the CT line) and B (20mm in front of the tragus and 10mm below the CT line); Local intra- and extra-oral antisepsis with aqueous chlorhexidine 0.12% and 0.2%, respectively; Local anesthesia of the auriculotemporal and intra-capsular nerve with mepivacaine 2% + Epinephrine 1:100,000; Insertion of the first 30x0.8 mm needle at point A and injection of 2-3 mL of Lactated Ringer; Insert the second 30x0.8 mm needle into point B Wash with 100-200mL of Ringer Lactate; Removal of the second needle; Injection of 1mL of 20mg Triamcinolone diluted in 0.9% saline solution (1:1) through the needle at point A.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare occlusal splint and arthrocentesis in patients with disc displacement with/without reduction. The main question it aims to answer are:

• Is there a more effective treatment for this cases?

Participants will answer a questionary about pain and functional limitations.

Researchers will compare Group 1(occlusal plate) and Gruoup 2 (arthrocentesis) to see if there is pain reduction and functional improvement in patients with disc displacement with/without reduction

Detailed description: Introduction: Temporomandibular joint disc displacement is a disorder in which the articular disc is anteriorly displaced from its correct position in relation to the mandibular condyle and mandibular fossa. Traditionally, the initial treatment of disc displacements involves several conservative measures, among them, the stabilizing interocclusal splint. However, in cases where there is associated opening limitation, such as intermittent lock and closed-lock, arthrocentesis has been suggested as another initial treatment modality due to its faster effect in preventing disease progression to a more advanced stage, in addition to reducing the chances of pain chronicity and central sensitization. Objectives: The present study aimed to compare and analyze the effectiveness and benefits of performing arthrocentesis as the initial treatment in patients with DDWR with intermittent lock and in patients with DDWoR, compared to the stabilizing interocclusal splint. Additionally, it had as secondary objectives to characterize the sample according to demographic, systemic, local and psychosocial factors in both groups and to correlate the clinical characteristics of the included patients with the imaging findings of the MRI scans. Methods: A randomized, prospective, longitudinal pilot study was performed. The sample was obtained by convenience from a demand through consultations and referral, among patients treated at the Oral and Maxillofacial Surgery Service of HCFMUSP, from June 2021 to July 2023. Patients with diagnoses of: DDWR intermittent lock and DDWoR with opening mouth limitation. Study patients underwent an initial assessment using a clinical questionnaire (DC/TMD) and underwent an initial TMJ MRI. Then, they were randomly divided into two groups according to the treatment to which they would be submitted: stabilizing inter-occlusal splint (group 1) or arthrocentesis (group 2). After treatment was instituted, patients were evaluated at 1, 2, 3 and 6 months regarding clinical parameters of pain, functionality and psychosocial status.

Eligibility criteria: Inclusion Criteria:

* Patients at least 18 years old;
* Diagnosed with disc displacement with reduction with intermittent block or disc displacement without reduction;
* Availability of clinical follow-up for 6 months.

Exclusion Criteria:

* Pregnant patients;
* Patients undergoing conservative or invasive interventions to treat TMD in the last 6 months;
* Inability to use a stabilizing occlusal splint;
* Presence of toothache, neoplasms or medical contraindication for study participation.

Primary outcomes:
measure: Jaw function available in mouth opening and moviments of jaw
timeFrame: 6 months
Secondary outcomes:
measure: Pain available through of Visual Analogue Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo Faculty of Medicine Clinics Hospital
Study officials:
References: