Clinical trial NCT06766851: Evaluation of the Effectiveness of Arthrocentesis Using Catheter in the Treatment of Temporamandibular Joint Disorders
Official title: Comparison of Single-Needle Arthrocentesis and Intravenous Catheter-Assisted Arthrocentesis in the Management of Temporomandibular Joint Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TMJ Disc Disorder
Treatment
Arthrocentesis
Keywords: Branul
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study focused on arthrocentesis performed using a catheter, aiming to assess its effects on pain perception and mouth opening in patients with TMJ disorders.

Detailed description: Two groups will be formed consisting of patients who present with complaints of TMJ pain, limited mouth opening and hearing sounds in the joint and are diagnosed with TMJ disorder. After explaining the I-PRF protocol obtained by taking blood to both groups and obtaining the necessary consents, arthrocentesis will be performed on the relevant joint area using a catheter for the patients in the first group and a single needle for the patients in the second group. Patients will be called for check-ups on the 1st day, 1st week and 1st month after the protocols and the current perceived pain level before and after the treatment will be determined by scoring with Visual Analog Scala (VAS) and measuring the mouth opening with a ruler ( mm).

Eligibility criteria: Patients included in this study were adult individuals aged 18 years and older who were diagnosed with stage 3 or higher temporomandibular joint (TMJ) disorder according to the Wilkes classification, based on magnetic resonance imaging (MRI) in addition to clinical evaluation. Eligible patients had unilateral internal TMJ disorder and exhibited clinical symptoms such as TMJ-related pain and/or joint sounds, and limited mouth opening. Furthermore, only patients whose symptoms persisted despite at least one month of occlusal splint therapy were included.

Exclusion criteria were as follows: patients diagnosed with myofascial pain or muscle-related functional limitation; those who had previously undergone intra-articular injection or other invasive procedures involving the TMJ; patients with connective tissue diseases such as rheumatoid arthritis or with neurological disorders; patients with a history of major jaw trauma; and individuals with psychiatric disorders or a history of substance abuse.

Primary outcomes:
measure: The measurement of pain-free maximum mouth opening (MMO) in millimeters
timeFrame: Preopretive, Postoperative 1st day, 1st week and 1st month
measure: Change in post-operative pain assessed
timeFrame: Preoperative, Postoperative 1st day, 1st week and 1st month
Secondary outcomes:
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Eskişehir Osmangazi University
Study officials:
References:
citation: Hasanoglu Erbasar GN, Senturk MF, Sancak K. The Short-Term Results of the Modified Concentric-Needle Technique for Single-Puncture Arthrocentesis: A Preliminary Study. J Coll Physicians Surg Pak. 2024 Jun;34(6):717-722. doi: 10.29271/jcpsp.2024.06.717.
citation: Senturk MF, Yazici T, Gulsen U. Techniques and modifications for TMJ arthrocentesis: A literature review. Cranio. 2018 Sep;36(5):332-340. doi: 10.1080/08869634.2017.1340226. Epub 2017 Jun 15.