EFFECT OF TMJ ARTHROCENTESIS ON ARTICULAR CAPSULAR WIDTH: AN ULTRASONOGRAPHIC STUDY (TMJ ARTHROCENT)

April 22, 2026 updated by: sema kaya, Yuzuncu Yil University

TEMPOROMANDIBULAR JOINT ARTHROCENTESIS AND ITS EFFECT ON ARTICULAR CAPSULAR WIDTH: A CLINICAL ULTRASONOGRAPHIC STUDY

This study is designed as a prospective cohort study evaluating the effect of temporomandibular joint arthrocentesis on articular capsular width using ultrasonography. The study is being conducted at the Faculty of Dentistry, Van Yuzuncu Yil University, Turkey, in accordance with the principles of the Declaration of Helsinki. Ethical approval has been obtained from the Van Yuzuncu Yil University Clinical Research Ethics Committee (approval no. 2025/02-07, dated February 28, 2025).

The study includes systemically healthy adult participants with unilateral intra-articular temporomandibular disorder who have not responded adequately to at least six months of conservative management, including medication, occlusal splint therapy, or physiotherapy. Exclusion criteria are systemic rheumatologic diseases, bony or fibrous ankylosis of the temporomandibular joint, previous open temporomandibular joint surgery, pregnancy or breastfeeding, and active infection.

All participants undergo unilateral temporomandibular joint arthrocentesis performed under local anesthesia by a single experienced oral and maxillofacial surgeon. A standard two-needle technique is used, and the upper joint compartment is irrigated with 150-200 mL of sterile Ringer's lactate solution. No pharmacological agents are injected after the lavage. The contralateral, asymptomatic joint serves as an untreated control.

Ultrasonographic and clinical assessments are performed at three time points: baseline before the procedure (T0), three months post-arthrocentesis (T1), and six months post-arthrocentesis (T2). The primary outcome is capsular width measured by ultrasonography. Secondary outcomes include pain intensity assessed using the visual analog scale, maximum incisal opening measured in millimeters, and lateral and protrusive mandibular movements.

All ultrasonographic evaluations and clinical measurements are performed by a single oral and maxillofacial radiologist who is independent of the surgical procedure and postoperative patient management, ensuring blinding and minimizing bias. Pain scores are self-reported by patients without investigator interpretation.

The sample size was calculated a priori using G*Power software. Based on previous morphometric data, a minimum of 26 participants was required, and 27 participants were enrolled to account for potential dropouts. Statistical analyses include the Wilcoxon signed-rank test, Friedman test, and Mann-Whitney U test, with a significance level set at p < 0.05.

This study is one of the first prospective clinical trials to evaluate longitudinal changes in temporomandibular joint capsular width using ultrasonography following arthrocentesis. The study has received no external funding, and the authors declare no competing interests.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Temporomandibular joint (TMJ) arthrocentesis is a minimally invasive procedure used to treat intra-articular temporomandibular disorders (TMD) that are unresponsive to conservative management. This prospective cohort study aims to evaluate the effect of TMJ arthrocentesis on articular capsular width using ultrasonography, while concurrently assessing clinical outcomes including pain, maximum incisal opening, and mandibular movements.

The study is conducted at Van Yuzuncu Yil University Faculty of Dentistry, Turkey. Ethical approval was obtained from the Van Yuzuncu Yil University Non-Interventional Clinical Research Ethics Committee (approval no. 2025/02-07, dated February 28, 2025). The study adheres to the principles of the Declaration of Helsinki and follows TREND reporting guidelines for quasi-experimental studies.

All participants undergo unilateral TMJ arthrocentesis performed under local anesthesia using a standard two-needle technique. The upper joint compartment is irrigated with 150-200 mL of sterile Ringer's lactate solution. No pharmacological agents are injected after lavage. The contralateral asymptomatic joint serves as an untreated control.

Ultrasonographic and clinical assessments are performed at three time points: baseline (T0, pre-treatment), three months post-arthrocentesis (T1), and six months post-arthrocentesis (T2). All ultrasonographic evaluations are performed by a single oral and maxillofacial radiologist with 12 years of experience, using a high-resolution ultrasound device with a 14-16 MHz linear transducer. Capsular width is measured as the linear distance between the hyperechoic capsular line and the hyperechoic cortical outline of the mandibular condyle.

Clinical assessments include pain intensity measured by visual analog scale (VAS, 0-10), maximum incisal opening (MIO) in millimeters, lateral mandibular movements (left and right), and protrusive mandibular movement. All clinical measurements are performed by the same blinded assessor.

Statistical analyses are performed using SPSS software. The Friedman test is used for repeated measurements across three time points, followed by post-hoc pairwise comparisons using the Wilcoxon signed-rank test with Bonferroni correction. Between-group comparisons (affected vs. non-affected side) are performed using the Wilcoxon signed-rank test. A p-value of less than 0.05 is considered statistically significant.

Sample size was determined a priori using G*Power software. Based on previous morphometric data, a minimum of 26 participants was required. To account for potential dropouts, 27 participants were enrolled. A post-hoc power analysis based on the observed effect size for the primary outcome (Cohen's d = 1.42) confirmed >99% statistical power.

The study has received no external funding. The datasets are available from the corresponding author upon reasonable request.

Study Type

Interventional

Enrollment (Actual)

27

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)
      • Van, Turkey (Türkiye)
        • Van Yuzuncu Yil University Dentistry Faculty

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

Accepts Healthy Volunteers

No

Description

INCLUSION CRITERIA:

Systemically healthy adults with unilateral intra-articular TMD (disc displacement with or without reduction) for ≥6 months unresponsive to conservative treatment

EXCLUSION CRITERIA:

Rheumatologic diseases, TMJ ankylosis, previous open TMJ surgery, pregnancy/breastfeeding, active infection

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: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1. Arm/Grup: Affected side (Arthrocentesis)
Two-needle TMJ arthrocentesis under local anesthesia. Upper joint compartment irrigated with 150-200 mL sterile Ringer's lactate solution. No post-lavage injection.
Procedure: Arthrocentesis with ringer solution
TWO-NEEDLE TMJ ARTHROCENTESIS UNDER LOCAL ANESTHESIA. UPPER JOINT COMPARTMENT IRRIGATED WITH 150-200 ML STERILE RINGER'S LACTATE SOLUTION. NO PHARMACOLOGICAL AGENTS INJECTED AFTER LAVAGE.
No Intervention: 2. Arm/Grup: Non-affected side (Control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TMJ CAPSULAR WIDTH
Time Frame: MEASURED AT T0 (BASELINE), T1 (3 MONTHS), AND T2 (6 MONTHS) POST-ARTHROCENTESIS.
ULTRASONOGRAPHIC MEASUREMENT OF LINEAR DISTANCE BETWEEN HYPERECHOIC CAPSULAR LINE AND HYPERECHOIC CONDYLAR CORTEX IN MILLIMETERS.
MEASURED AT T0 (BASELINE), T1 (3 MONTHS), AND T2 (6 MONTHS) POST-ARTHROCENTESIS.

Collaborators and Investigators

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

Sponsor

Yuzuncu Yil University

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)

March 1, 2025

Primary Completion (Actual)

January 1, 2026

Study Completion (Actual)

January 1, 2026

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VANYYU_ARTHRO_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

DATA MAY BE AVAILABLE FROM THE CORRESPONDING AUTHOR UPON REASONABLE REQUEST.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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