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Clinical Trials/NCT06256042
NCT06256042
Completed
Not Applicable

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

University of Sao Paulo General Hospital1 site in 1 country24 target enrollmentMay 30, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Temporomandibular Joint Disc Displacement
Sponsor
University of Sao Paulo General Hospital
Enrollment
24
Locations
1
Primary Endpoint
Jaw function available in mouth opening and moviments of jaw
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 30, 2021
End Date
January 15, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gustavo Grothe Machado

Director of Oral and Maxillofacial Surgery Service

University of Sao Paulo General Hospital

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.

Outcomes

Primary Outcomes

Jaw function available in mouth opening and moviments of jaw

Time Frame: 6 months

millimeter scale

Secondary Outcomes

  • Pain available through of Visual Analogue Scale(6 months)

Study Sites (1)

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