Evaluation of the Effectiveness of Arthrocentesis Using Catheter in the Treatment of Temporamandibular Joint Disorders

September 15, 2025 updated by: Gorkem Tekin, Eskisehir Osmangazi University

Comparison of Single-Needle Arthrocentesis and Intravenous Catheter-Assisted Arthrocentesis in the Management of Temporomandibular Joint Disorders

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Eskişehir, Turkey (Türkiye), 26480
        • Eskisehir Osmangazi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: conventional single needle group
Patients presenting temporomandibular joint disc displacement without reduction (DDwoR) treated with single puncture arthrocentesis + I-PRF
Other: Procedure: TMJ Arthrocentesis
Temporomandibular joint arthrocentesis
Experimental: Catheter group
Patients presenting temporomandibular joint disc displacement without reduction (DDwoR) treated with catheter arthrocentesis. The upper joint space was entered with a 16 gauge 45 mm long branul. The 16 gauge metal cannula was removed and the plastic sheath was left in the upper joint space. The 18 gauge metal cannula, which was 1 size smaller, was placed inside the sheath. The irrigation solution was administered through the 18 gauge metal cannula and the irrigation solution flowed out of the space between the cannula and the sheath + I-PRF
Other: Procedure: TMJ Arthrocentesis
Temporomandibular joint arthrocentesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The measurement of pain-free maximum mouth opening (MMO) in millimeters
Time Frame: Preopretive, Postoperative 1st day, 1st week and 1st month
Pain-free MMO was measured as the distance between the incisal edges of the upper and lower incisors while patient's mouth is open as possible without any assistance and without pain. Three measurements were performed, and their average is recorded.
Preopretive, Postoperative 1st day, 1st week and 1st month
Change in post-operative pain assessed
Time Frame: Preoperative, Postoperative 1st day, 1st week and 1st month
A visual analog scale (VAS) was used, grading from 1 to 10 (1: no pain, 10: unbearable pain)
Preoperative, Postoperative 1st day, 1st week and 1st month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eskisehir Osmangazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2024

Primary Completion (Actual)

August 15, 2025

Study Completion (Actual)

September 15, 2025

Study Registration Dates

First Submitted

January 4, 2025

First Submitted That Met QC Criteria

January 8, 2025

First Posted (Actual)

January 9, 2025

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EskisehirOU-TEKIN-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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