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

Effectiveness of Arthrocentesis and the Occlusal Splint in Treatment of Disc Displacements of the Temporomandibular Joint

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

Study Overview

• Status: Completed
• Conditions: Temporomandibular Joint Disc Displacement; Anterior Disc Displacement
• Intervention / Treatment: Procedure: Arthrocentesis; Procedure: Occlusal splint

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05.403-905
    • University of São Paulo Faculty of Medicine Clinics Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Arthrocentesis; The patient then underwent arthrocentesis of the temporomandibular joint itself, following the Nitzan technique.
Active Comparator: Occlusal splint; A stabilizing maxillary acrylic occlusal splint was made, flat, total and adjusted in central relation (RC).	Procedure: Occlusal splint; a stabilizing maxillary acrylic occlusal splint was made, flat, total and adjusted in central relation (RC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Jaw function available in mouth opening and moviments of jaw	millimeter scale	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain available through of Visual Analogue Scale	the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10. It's been 0 (without pain) and 10 (worst pain)	6 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): January 15, 2024

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: February 4, 2024
• First Posted (Estimated): February 13, 2024

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Arthrocentesis; Anterior disc displacement; Temporomandibular joint; Interocclusal stabilizing splint.
• Additional Relevant MeSH Terms: Anti-Infective Agents; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Salicylic Acid
• Other Study ID Numbers: 50207321.8.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No