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

NCT07553078 | Completed

• 1 other identifier: VANYYU_ARTHRO_01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

TEMPOROMANDIBULAR JOINT DISORDER

Keywords

TEMPORO MANDIBULAR JOINT; ARTHROCENTESIS; ULTRASONOGRAPHY

Outcome Measures

Primary Outcomes (1)

• TMJ CAPSULAR WIDTH

  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.

Study Arms (2)

1. Arm/Grup: Affected side (Arthrocentesis)

EXPERIMENTAL

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

2. Arm/Grup: Non-affected side (Control)

NO INTERVENTION

Interventions

Arthrocentesis with ringer solution PROCEDURE

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.

1. Arm/Grup: Affected side (Arthrocentesis)

Eligibility Criteria

• Age: 29 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yuzuncu Yil University Dentistry Faculty

Van, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Arthrocentesis; Ringer's Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 27, 2026
• Study Start: March 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)