Comparative Assessment of Arthrocentesis Methods in TMJ Disorders

NCT07327099 | Completed

• 1 other identifier: KTU-DHF-HMO-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorders (TMD); Temporomandibular Joint Disc Displacement, With Reduction

Outcome Measures

Primary Outcomes (1)

• TMJ Pain

  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.

  before the procedure, at 1 month and at 6 months

Study Arms (2)

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.

Procedure: Y-shaped cannula without a source

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.

Procedure: Y-shaped cannula with a source

Interventions

Y-shaped cannula without a source PROCEDURE

Y-shaped cannula without a source Arthrocentesis performed by simultaneously and concentrically placing two manually Y-shaped bent needles into the joint cavity.

Non-Welded Y-Cannula Group

Y-shaped cannula with a source PROCEDURE

Y-shaped cannula with a source Arthrocentesis performed by simultaneously and concentrically placing two manually Y-shaped bent needles into the joint cavity.

Welded Y-Cannula Group

Eligibility Criteria

• Age: 17 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Helin Merve Özalp: lead

Study Sites (1)

Ktu Dentistry

Trabzon, Ortahisar, 61000, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 28618972 RESULT

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: ressearcher assistant

Model Details: Arthrocentesis was performed on the first group using a method developed by Mun et al., involving two 22-gauge needles bent to form a 'Y' shape with the tips facing each other, and on the second group using a factory-made Y-shaped cannula developed by Rahal et al.

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 8, 2026
• Study Start: August 1, 2024
• Primary Completion: August 15, 2025
• Study Completion: September 15, 2025
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)