Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06256042 |
Other study ID # |
50207321.8.0000.0068 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 30, 2021 |
Est. completion date |
January 15, 2024 |
Study information
Verified date |
February 2024 |
Source |
University of Sao Paulo General Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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
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.