Comparing Two-Needle vs. Surgery-Guided Arthrocentesis for TMJ Disorders

Not Applicable

Completed

• Conditions: Temporomandibular Joint Disorders
• Interventions: Procedure: Surgery-Guided Arthrocentesis; Procedure: Traditional Two-Needle Arthrocentesis

• Registration Number: NCT06055855
• Lead Sponsor: Marmara University

Brief Summary

The goal of this clinical trial is to compare two methods of arthrocentesis in treating temporomandibular joint (TMJ) disorders. The main questions it aims to answer are:

Is surgery-guided arthrocentesis more efficient in terms of operation time compared to traditional two-needle arthrocentesis? Does the use of surgical guides lead to less postoperative pain and better patient comfort?

Participants will:

Undergo either the traditional two-needle arthrocentesis or the surgery-guided arthrocentesis.

Be monitored for operation time, postoperative pain, and overall patient comfort.

Researchers will compare the outcomes of patients who underwent traditional two-needle arthrocentesis with those who had surgery-guided arthrocentesis to see if the latter can shorten operation time and improve patient comfort.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-10
• Study First Submitted: 2023-09-20
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-28
• Primary Completion: 2024-02-10
• Study Completion: 2024-02-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients diagnosed with Wilkes stage II, III, or IV Temporomandibular Joint (TMJ) internal derangement.
• Presence of pain, sound, or both in the TMJ.
• Limitation or locking in mouth opening, or both.
• Patients who have not responded to symptoms after a minimum of three months of splint therapy.

Exclusion Criteria

• Presence of infection in the puncture area.
• Presence of osteomyelitis in the neighboring region.
• Patients with uncontrolled coagulopathies.
• Patients experiencing limitation in maximum mouth opening without disk disorder.
• Patients with severe degenerative joint disease (e.g., deformed condylar contour, osteophyte findings in MRI).
• History of TMJ surgery.
• History of muscle-originated mandibular hypomobility.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery-Guided Arthrocentesis Group	Surgery-Guided Arthrocentesis	-
Traditional Arthrocentesis Group	Traditional Two-Needle Arthrocentesis	-

Primary Outcome Measures

Name	Time	Method
Total Duration of Arthrocentesis Procedure	Immediately following the completion of each arthrocentesis procedure, anticipated to occur on the day of the surgery.	he primary outcome measure of the study is the total time duration required to complete the arthrocentesis procedure. This duration will be measured from the time local anesthesia is administered to the time when the arthrocentesis is completed. In addition, the number of intraoperative repositions of the needles will also be recorded.

Secondary Outcome Measures

Name	Time	Method
Change in Mouth Opening	7 days	The distance between the mesio-incisal corners of the upper and lower central incisors was measured with the help of a ruler when the mouth opening was at its maximum.
Volume of Ringer's Solution Used for Joint Irrigation	Immediately following the completion of each arthrocentesis procedure, anticipated to occur on the day of the surgery.	The volume of Ringer's solution used to irrigate the temporomandibular joint during the arthrocentesis procedure will be measured.
Change in Postoperative Pain	7 days	Change in muscle pain intensity will be evaluated using a Visual Analogue Scale (VAS). The VAS comprises a 10 cm line, which can be presented either horizontally or vertically, anchored by "no pain" and "worst possible pain." Patients will be instructed to place a mark on the line that most accurately describes their level of muscle pain. These marks will be recorded and scored according to the VAS scale.
Change in Facial Swelling	7 days	With the technique described by Neupert ; Angle of mandible-tragus Angle of mandible-lateral canthus of eye Mandible corner-nose wing Angle of mandible oral-commissures Measurements were made with a tape measure from 5 points, with the mandible corner-pogonion.

Trial Locations

Locations (1)

Marmara University School of Dentistry; 🇹🇷 Istanbul, Turkey