Effectiveness of Arthrocentesis and the Occlusal Splint in Treatment of the TMJ

NCT ID: NCT06256042

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-30
• Study Completion Date: 2024-01-15

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.

Conditions

Temporomandibular Joint Disc Displacement; Anterior Disc Displacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Arthrocentesis

Intervention Type: PROCEDURE

The patient then underwent arthrocentesis of the temporomandibular joint itself, following the Nitzan technique.

Occlusal splint

A stabilizing maxillary acrylic occlusal splint was made, flat, total and adjusted in central relation (RC).

Group Type: ACTIVE_COMPARATOR

Occlusal splint

Intervention Type: PROCEDURE

a stabilizing maxillary acrylic occlusal splint was made, flat, total and adjusted in central relation (RC).

Interventions

Occlusal splint

a stabilizing maxillary acrylic occlusal splint was made, flat, total and adjusted in central relation (RC).

Intervention Type: PROCEDURE

Arthrocentesis

The patient then underwent arthrocentesis of the temporomandibular joint itself, following the Nitzan technique.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gustavo Grothe Machado

Director of Oral and Maxillofacial Surgery Service

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of São Paulo Faculty of Medicine Clinics Hospital

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

50207321.8.0000.0068

Identifier Type: -

Identifier Source: org_study_id