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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06256042
Enrollment
24
Registered
2024-02-13
Start date
2021-05-30
Completion date
2024-01-15
Last updated
2024-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Joint Disc Displacement, Anterior Disc Displacement

Keywords

Temporomandibular joint, Anterior disc displacement, Arthrocentesis, Interocclusal stabilizing splint.

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.

Interventions

PROCEDUREOcclusal splint

a stabilizing maxillary acrylic occlusal splint was made, flat, total and adjusted in central relation (RC).

The patient then underwent arthrocentesis of the temporomandibular joint itself, following the Nitzan technique.

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Stabilizing interocclusal plate (IOP): a stabilizing maxillary acrylic occlusal plate was made, flat, total and adjusted in central relation (RC). Advice and guidance on the disease. 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Jaw function available in mouth opening and moviments of jaw6 monthsmillimeter scale

Secondary

MeasureTime frameDescription
Pain available through of Visual Analogue Scale6 monthsthe 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)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026