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

July 11, 2024 updated by: Ferit Bayram, Marmara University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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
      • Istanbul, Turkey, 34854
        • Marmara University School of Dentistry

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional Arthrocentesis Group
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.
Experimental: Surgery-Guided Arthrocentesis Group
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Duration of Arthrocentesis Procedure
Time Frame: 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.
Immediately following the completion of each arthrocentesis procedure, anticipated to occur on the day of the surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of Ringer's Solution Used for Joint Irrigation
Time Frame: 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.
Immediately following the completion of each arthrocentesis procedure, anticipated to occur on the day of the surgery.
Change in Postoperative Pain
Time Frame: 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.
7 days
Change in Mouth Opening
Time Frame: 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.
7 days
Change in Facial Swelling
Time Frame: 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.
7 days

Collaborators and Investigators

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

Sponsor

Marmara 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)

September 10, 2023

Primary Completion (Actual)

February 10, 2024

Study Completion (Actual)

February 10, 2024

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 11, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUDHF_FB_007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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