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

Primary Purpose

Temporomandibular Joint Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Traditional Two-Needle Arthrocentesis
Surgery-Guided Arthrocentesis
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring Arthrocentesis,Temporomandibular Joint, Guided surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Marmara University School of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional Arthrocentesis Group

Surgery-Guided Arthrocentesis Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
September 20, 2023
Last Updated
September 20, 2023
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT06055855
Brief Title
Comparing Two-Needle vs. Surgery-Guided Arthrocentesis for TMJ Disorders
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2023 (Actual)
Primary Completion Date
February 10, 2024 (Anticipated)
Study Completion Date
September 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
Arthrocentesis,Temporomandibular Joint, Guided surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional Arthrocentesis Group
Arm Type
Active Comparator
Arm Title
Surgery-Guided Arthrocentesis Group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Traditional Two-Needle Arthrocentesis
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Surgery-Guided Arthrocentesis
Intervention Description
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 Outcome Measure Information:
Title
Total Duration of Arthrocentesis Procedure
Description
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.
Time Frame
Immediately following the completion of each arthrocentesis procedure, anticipated to occur on the day of the surgery.
Secondary Outcome Measure Information:
Title
Volume of Ringer's Solution Used for Joint Irrigation
Description
The volume of Ringer's solution used to irrigate the temporomandibular joint during the arthrocentesis procedure will be measured.
Time Frame
Immediately following the completion of each arthrocentesis procedure, anticipated to occur on the day of the surgery.
Title
Change in Postoperative Pain
Description
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.
Time Frame
7 days
Title
Change in Mouth Opening
Description
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.
Time Frame
7 days
Title
Change in Facial Swelling
Description
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.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Marmara University School of Dentistry
City
Istanbul
ZIP/Postal Code
34854
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ferit Bayram, Ph. D.
Phone
2167775000
Email
ferit.bayram@marmara.edu.tr
First Name & Middle Initial & Last Name & Degree
Gökhan Göçmen

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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