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

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ClinicalTrials.gov Identifier: NCT06055855
Recruitment Status : Completed
First Posted : September 28, 2023
Last Update Posted : February 22, 2024
Sponsor:
Information provided by (Responsible Party):
Ferit Bayram, Marmara University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Temporomandibular Joint Disorders Procedure: Traditional Two-Needle Arthrocentesis Procedure: Surgery-Guided Arthrocentesis Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 10, 2023
Actual Primary Completion Date : February 10, 2024
Actual Study Completion Date : February 10, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06055855


Locations
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Turkey
Marmara University School of Dentistry
Istanbul, Turkey, 34854
Sponsors and Collaborators
Marmara University
More Information
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Responsible Party: Ferit Bayram, Principal Investigator, Marmara University
ClinicalTrials.gov Identifier: NCT06055855    
Other Study ID Numbers: MUDHF_FB_007
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: February 22, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ferit Bayram, Marmara University:
Arthrocentesis,Temporomandibular Joint
Guided surgery
Additional relevant MeSH terms:
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Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Musculoskeletal Diseases
Craniomandibular Disorders
 Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes