Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06256042
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2024-01-23
Brief Title:
Effectiveness of Arthrocentesis and the Occlusal Splint in Treatment of the TMJ
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
Official Title:
Effectiveness of Arthrocentesis and the Occlusal Splint in Treatment of Disc Displacements of the Temporomandibular Joint
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare occlusal splint and arthrocentesis in patients with disc displacement withwithout 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 1occlusal plate and Gruoup 2 arthrocentesis to see if there is pain reduction and functional improvement in patients with disc displacement withwithout reduction
Is there a more effective treatment for this cases
Participants will answer a questionary about pain and functional limitations
Researchers will compare Group 1occlusal plate and Gruoup 2 arthrocentesis to see if there is pain reduction and functional improvement in patients with disc displacement withwithout 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 DCTMD 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None