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Completed

NCT Number: NCT06055855

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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University School of Dentistry

Istanbul, 34854, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Traditional Two-Needle Arthrocentesis

Procedure

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

Procedure

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 28, 2023
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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