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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
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for TMJ Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 13, 2022
    Last Updated
    January 10, 2023
    Sponsor
    Sohag University
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    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

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    Role of Ultrasonography in Assessment of Tempromanbular Joint Disorders

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