- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07327099
Comparative Assessment of Arthrocentesis Methods in TMJ Disorders
Clinical Evaluation of Different Arthrocentesis Techniques in the Treatment of Temporomandibular Joint Disorders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction: Temporomandibular disorders (TMD) are common symptoms in society, characterized by pain, limited movement, and all sounds, which are often negatively impacted by individual life circumstances. The primary goal of treatment is to eliminate the etiological factors and restore the replaceable functions of the parts. Arthrocentesis, a minimally invasive approach, is emphasized in cases where conservative treatment is beneficial. Arthrocentesis reduces pain by removing inflammatory mediators and increases joint mobility. This effective treatment was evaluated by comparing the intraoperative parameters and clinical success of different arthrocentesis techniques in patients with Wilkes stage 2-3 TMJ disorders.
Materials and Methods: This study is being conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Karadeniz Technical University. Fifty patients (Group 1: n=25, Group 2: n=25) treated with two different arthrocentesis technologies were enrolled retrospectively. The first group was the study of Mun et al. Arthrocentesis was performed using the method employed by Rahal et al., which consisted of two 22-gauge needles bent to form a "Y" shape and placed simultaneously and concentrically. The second group underwent arthrocentesis using a fabricated Y-shaped cannula used by Rahal et al. Each treatment was performed under local anesthesia, and the upper regions were irrigated with an average of 100 ml of Ringer's lactate solution. Following arthrocentesis, 1 ml of hyaluronic acid was injected into the patients. Preoperative and postoperative values were evaluated by comparing the groups at 1 to 6 months. Furthermore, intraoperative arthrocentesis efficiency (number of needle insertions, procedure time, complication rate, and treatment tolerance) was compared between the groups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ortahisar
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Trabzon, Ortahisar, Turkey (Türkiye), 61000
- Ktu Dentistry
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients with unilateral TME disorders who:
- Are in stages 2-3 of the Wilkes classification
- Have not undergone interventional treatment prior to arthroscopy
- Have undergone conservative treatment prior to arthroscopy without successful results
Exclusion Criteria:
- Patients with TME irregularities who have undergone interventional treatment (minimally invasive and invasive)
- Patients with bilateral TME disorders
- Patients with incomplete recorded data
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Non-Welded Y-Cannula Group
Group 1: The first group underwent arthrocentesis using a method developed by Mun et al., involving two 22-gauge needles bent to form a Y-shape with their angles facing each other.
|
Y-shaped cannula without a source Arthrocentesis performed by simultaneously and concentrically placing two manually Y-shaped bent needles into the joint cavity.
|
|
Active Comparator: Welded Y-Cannula Group
Group 2: The second group underwent arthrocentesis using a method developed by Rahal et al., involving a factory-made Y-shaped cannula.
|
Y-shaped cannula with a source Arthrocentesis performed by simultaneously and concentrically placing two manually Y-shaped bent needles into the joint cavity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TMJ Pain
Time Frame: before the procedure, at 1 month and at 6 months
|
TMJ Pain intensity was assessed using the Visual Analog Scale (VAS).
The VAS ranges from a minimum score of 1 to a maximum score of 10, where 1 indicates the best condition (no pain) and 10 indicates the worst condition (maximum pain).
Higher scores on the scale represent greater pain severity.
Accordingly, an increase in the score reflects a higher level of perceived pain by the patients.
|
before the procedure, at 1 month and at 6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KTU-DHF-HMO-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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