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

Temporomandibular Joint Disorders Clinical Trial

Official title:

A Randomized Controlled Trial Evaluating the Efficacy of Conventional Two-Needle Arthrocentesis Versus Surgery-Guided Arthrocentesis in the Management of Temporomandibular Joint Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06055855
• Other study ID #: MUDHF_FB_007
• Status: Completed
• Phase: N/A
• Start date: September 10, 2023
• Est. completion date: February 10, 2024

Study information

• Verified date: February 2024
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 10, 2024
• Est. primary completion date: February 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Procedure:
• Traditional Two-Needle Arthrocentesis
Participants in this group will undergo arthrocentesis using the traditional two-needle technique. The procedure involves the placement of one or two needles into the temporomandibular joint (TMJ) to irrigate the joint space. Needle placement is guided by anatomical landmarks.
• Surgery-Guided Arthrocentesis
Participants in this group will receive arthrocentesis facilitated by a surgical guide. The guide is generated through pre-operative planning and is designed to aid in the accurate placement of the needle into the TMJ.

Locations

Country	Name	City	State
Turkey	Marmara University School of Dentistry	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Duration of Arthrocentesis Procedure	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.	Immediately following the completion of each arthrocentesis procedure, anticipated to occur on the day of the surgery.
Secondary	Volume of Ringer's Solution Used for Joint Irrigation	The volume of Ringer's solution used to irrigate the temporomandibular joint during the arthrocentesis procedure will be measured.	Immediately following the completion of each arthrocentesis procedure, anticipated to occur on the day of the surgery.
Secondary	Change in Postoperative Pain	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.	7 days
Secondary	Change in Mouth Opening	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.	7 days
Secondary	Change in Facial Swelling	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.	7 days