Role of Ultrasonography in Assessment of Tempromanbular Joint Disorders
Primary Purpose
TMJ Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
US guided TMJ intra articular injection
Sponsored by
About this trial
This is an interventional treatment trial for TMJ Disorder
Eligibility Criteria
Inclusion Criteria:
- Male and female diagnosed as TMJ disorders (clinically through history of the presentation and physical examination (site, onset, character of pain, radiation, duration and associated symptoms. This pain may refer to the scalp or neck, and is often exacerbated by mastication, yawning or talking for extended periods. Difficulty opening the mouth, clicking, popping or crepitus within the TMJ itself and brief locking of the mandible on jaw opening and closure and Headache, particularly tension type headache).
Exclusion Criteria:
- Uncooperative patients, systemic disease with TMJ involvement as Rheumatoid, psoriatic, and juvenile idiopathic arthritis. Contraindications for MRI : claustrophobia , metallic implants , pacemaker and prosthetic heart valves .Contraindication for intra articular injection : the patients with bleeding disorders , pregnancy , bony pathology of TMJ , allergy to local anesthetic and those on narcotics or anti depressant .
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TMD patients with joint hyper mobility
Arm Description
Outcomes
Primary Outcome Measures
Change of temporomandibular joint imaging by ultrasonography and magnetic resonance imaging .
Imaging of the temporomandibular joint by ultrasonography and imaging by magnetic resonance imaging .
Change of mobility of the temporomandibular joint before and after ultrasonography guided blood injection .
Measuring the temporomandibular joint mobility in millimeters by ultrasonography before and after sonar guided injection .
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05320770
Brief Title
Role of Ultrasonography in Assessment of Tempromanbular Joint Disorders
Official Title
Role Of Ultrasonography Compared To MR Imaging In Assessment Of Tempromandibular Joint Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag 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
Evaluation of US efficiency in assessment of the tempromandibular joint disorders in comparison with MRI as the gold standard for technique validation and evaluation of efficiency of therapeutic intra articular injection under sonographic guidance .
Detailed Description
Temporomandibular joint disorders is a common condition, Intra-articular causes of TMD include internal joint derangement, osteoarthritis, capsular inflammation, hypermobility and traumatic injury. The most frequent cause of TMJ dysfunction is internal derangement which refers to an alteration in the normal pathways of motion of the TMJ that largely involves the function of the articular disc, therefore, these alterations have been also referred to as disc derangement , signs of which appear in up to 60-70% of the population. The peak incidence is seen in adults aged 20-40 years. Women are at least four times as likely to suffer from the disorder .
Magnetic resonance imaging (MRI) has provided a noninvasive accurate method of assessing the TMJ without associated radiation risks ,its ability to directly visualize the disc and accurately determine the position of the disc with respect to the condyle of the mandible and eminence of the temporal bone. The examination, however, takes 20 to 45 minutes on average to perform depending on the scanner and protocol, and patients have difficulty keeping still and having their mouths open for extended periods of time, especially if they are experiencing pain. In addition, the examination is costly and access is still limited in many centers. Many patients also experience claustrophobia and are unable to complete or even undergo the examination .
Ultrasound is relatively inexpensive, is readily accessible, and can be performed in most outpatient facilities; studies take only an average of 10 to 15 minutes in total, and it is without any known risks. In addition, US provides the opportunity to converse with patients and identify the exact locations of pain, while the probe can be used as a palpable tool for real-time identification of crepitus, clicking, motion, and snapping sensations.
The following US applications were described: Joint effusion, Internal derangement and disc displacement, mainly anterior with and without reduction, Joint function basing on condylar translation range, TMJ dislocation, Guidance in fine-needle aspiration cytology (FNAC), Guidance for TMJ arthrocentesis and Guidance in TMJ injections, e.g., with steroids , Blood .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TMJ Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TMD patients with joint hyper mobility
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
US guided TMJ intra articular injection
Intervention Description
therapeutic TMJ intra articulatr injection of blood under sonography guidance to reduce joint hyper mobility
Primary Outcome Measure Information:
Title
Change of temporomandibular joint imaging by ultrasonography and magnetic resonance imaging .
Description
Imaging of the temporomandibular joint by ultrasonography and imaging by magnetic resonance imaging .
Time Frame
Ultrasonography at baseline visit and MRI one week after baseline visit .
Title
Change of mobility of the temporomandibular joint before and after ultrasonography guided blood injection .
Description
Measuring the temporomandibular joint mobility in millimeters by ultrasonography before and after sonar guided injection .
Time Frame
Baseline visit and three months after the baseline intervention .
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female diagnosed as TMJ disorders (clinically through history of the presentation and physical examination (site, onset, character of pain, radiation, duration and associated symptoms. This pain may refer to the scalp or neck, and is often exacerbated by mastication, yawning or talking for extended periods. Difficulty opening the mouth, clicking, popping or crepitus within the TMJ itself and brief locking of the mandible on jaw opening and closure and Headache, particularly tension type headache).
Exclusion Criteria:
Uncooperative patients, systemic disease with TMJ involvement as Rheumatoid, psoriatic, and juvenile idiopathic arthritis. Contraindications for MRI : claustrophobia , metallic implants , pacemaker and prosthetic heart valves .Contraindication for intra articular injection : the patients with bleeding disorders , pregnancy , bony pathology of TMJ , allergy to local anesthetic and those on narcotics or anti depressant .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aliaa M Awad
Phone
01201240011
Email
aliaa011119@med.sohag.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Role of Ultrasonography in Assessment of Tempromanbular Joint Disorders
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