Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05320770
Other study ID # Soh-Med-22-02-05
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2023
Est. completion date April 2023

Study information

Verified date January 2023
Source Sohag University
Contact Aliaa M Awad
Phone 01201240011
Email aliaa011119@med.sohag.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .


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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date April 2023
Est. primary completion date March 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 .

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
US guided TMJ intra articular injection
therapeutic TMJ intra articulatr injection of blood under sonography guidance to reduce joint hyper mobility

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Outcome

Type Measure Description Time frame Safety issue
Primary Change of temporomandibular joint imaging by ultrasonography and magnetic resonance imaging . Imaging of the temporomandibular joint by ultrasonography and imaging by magnetic resonance imaging . Ultrasonography at baseline visit and MRI one week after baseline visit .
Primary 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 . Baseline visit and three months after the baseline intervention .
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT06087432 - Is PNF Application Effective on Temporomandibular Dysfunction N/A
Completed NCT06103110 - Effect of Order and Conjugation of Different Photobiomodulation Therapies and Anterior Repositioning Appliance in Management of TMD Cases N/A
Completed NCT04561037 - Pulsed Electromagnetic Field Therapy for TMJ Dysfunction After Facial Penetrating Injury N/A
Completed NCT04951908 - Correlation Between Types of Lateral Pterygoid Muscle Attachment and Internal Derangement of the Temporomandibular Joint
Recruiting NCT05882604 - MESNA Injection for TMJ Internal Derangement N/A
Completed NCT05712655 - Masticatory Muscles Electromyography in Post-pubertal Females With Forward Head Posture and Temporomandibular Disorders
Recruiting NCT04543981 - Prevalence of the Signs and Symptoms of TMD in Adolescents
Completed NCT04298554 - Comparison of Cannabinoids to Placebo in Management of TMJ Pain and Myofascial Pain in the TMJ Region N/A