Clinical Trials Directory

Trials / Completed

CompletedNCT06256042

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
University of Sao Paulo General Hospital · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
PROCEDUREOcclusal splinta stabilizing maxillary acrylic occlusal splint was made, flat, total and adjusted in central relation (RC).
PROCEDUREArthrocentesisThe patient then underwent arthrocentesis of the temporomandibular joint itself, following the Nitzan technique.

Timeline

Start date
2021-05-30
Primary completion
2022-02-28
Completion
2024-01-15
First posted
2024-02-13
Last updated
2024-02-13

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT06256042. Inclusion in this directory is not an endorsement.