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Clinical Trials/NCT07327099
NCT07327099
Completed
Not Applicable

Clinical Evaluation of Different Arthrocentesis Techniques in the Treatment of Temporomandibular Joint Disorders

Helin Merve Özalp1 site in 1 country50 target enrollmentStarted: August 1, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Helin Merve Özalp
Enrollment
50
Locations
1
Primary Endpoint
TMJ Pain

Overview

Brief Summary

Temporomandibular disorders (TMD) are common conditions in society, characterised by symptoms such as pain, limited movement and joint noises, which negatively affect an individual's quality of life. The primary goal of treatment is to restore the physiological functions of the joint by eliminating the aetiological factors. In cases where conservative methods prove ineffective, arthrocentesis, a minimally invasive approach, comes to the fore. Arthrocentesis aims to reduce pain by removing inflammatory mediators and to increase joint mobility. In this study, the intraoperative parameters and clinical outcomes of different arthrocentesis techniques were compared and evaluated in patients with Wilkes stage 2-3 TME disorders.

Detailed Description

Introduction

Temporomandibular disorders (TMD) are common symptoms in society, characterized by pain, limited movement, and all sounds, which are often negatively impacted by individual life circumstances. The primary goal of treatment is to eliminate the etiological factors and restore the replaceable functions of the parts. Arthrocentesis, a minimally invasive approach, is emphasized in cases where conservative treatment is beneficial. Arthrocentesis reduces pain by removing inflammatory mediators and increases joint mobility. This effective treatment was evaluated by comparing the intraoperative parameters and clinical success of different arthrocentesis techniques in patients with Wilkes stage 2-3 TMJ disorders.

Materials and Methods

This study is being conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Karadeniz Technical University. Fifty patients (Group 1: n=25, Group 2: n=25) treated with two different arthrocentesis technologies were enrolled retrospectively. The first group was the study of Mun et al. Arthrocentesis was performed using the method employed by Rahal et al., which consisted of two 22-gauge needles bent to form a "Y" shape and placed simultaneously and concentrically. The second group underwent arthrocentesis using a fabricated Y-shaped cannula used by Rahal et al. Each treatment was performed under local anesthesia, and the upper regions were irrigated with an average of 100 ml of Ringer's lactate solution. Following arthrocentesis, 1 ml of hyaluronic acid was injected into the patients. Preoperative and postoperative values were evaluated by comparing the groups at 1 to 6 months. Furthermore, intraoperative arthrocentesis efficiency (number of needle insertions, procedure time, complication rate, and treatment tolerance) was compared between the groups.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
17 Years to 75 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients with unilateral TME disorders who:
  • Are in stages 2-3 of the Wilkes classification
  • Have not undergone interventional treatment prior to arthroscopy
  • Have undergone conservative treatment prior to arthroscopy without successful results

Exclusion Criteria

  • Patients with TME irregularities who have undergone interventional treatment (minimally invasive and invasive)
  • Patients with bilateral TME disorders
  • Patients with incomplete recorded data

Arms & Interventions

Non-Welded Y-Cannula Group

Active Comparator

Group 1: The first group underwent arthrocentesis using a method developed by Mun et al., involving two 22-gauge needles bent to form a Y-shape with their angles facing each other.

Intervention: Y-shaped cannula without a source (Procedure)

Welded Y-Cannula Group

Active Comparator

Group 2: The second group underwent arthrocentesis using a method developed by Rahal et al., involving a factory-made Y-shaped cannula.

Intervention: Y-shaped cannula with a source (Procedure)

Outcomes

Primary Outcomes

TMJ Pain

Time Frame: before the procedure, at 1 month and at 6 months

TMJ Pain intensity was assessed using the Visual Analog Scale (VAS). The VAS ranges from a minimum score of 1 to a maximum score of 10, where 1 indicates the best condition (no pain) and 10 indicates the worst condition (maximum pain). Higher scores on the scale represent greater pain severity. Accordingly, an increase in the score reflects a higher level of perceived pain by the patients.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Helin Merve Özalp
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Helin Merve Özalp

ressearcher assistant

Karadeniz Technical University

Study Sites (1)

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