TMJ DisorderNCT05320770
Role of Ultrasonography in Assessment of Tempromanbular Joint Disorders
A study testing US guided TMJ intra articular injection in people with TMJ Disorder, run by Sohag University.
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 . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- TMJ Disorder
- What is being tested?
- US guided TMJ intra articular injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role Of Ultrasonography Compared To MR Imaging In Assessment Of Tempromandibular Joint Disorders
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 .
Read the 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 .
- Conditions
- TMJ Disorder
- Being tested
- US guided TMJ intra articular injection
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US guided TMJ intra articular injectionProcedure or surgery
therapeutic TMJ intra articulatr injection of blood under sonography guidance to reduce joint hyper mobility
| Study group | Role | What they receive |
|---|---|---|
| TMD patients with joint hyper mobility | Experimental | Not described Receives: Procedure: US guided TMJ intra articular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of temporomandibular joint imaging by ultrasonography and magnetic resonance imaging .
Imaging of the temporomandibular joint by ultrasonography and imaging by magnetic resonance imaging .
Measured: Ultrasonography at baseline visit and MRI one week after baseline visit .
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 .
Measured: Baseline visit and three months after the baseline intervention .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study startFeb 2023 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ DisorderStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alyaa Mohammed Awad, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320770
- Sponsor's protocol ID
- Soh-Med-22-02-05
- Status last verified
- Jan 2023
- First submitted
- 13 Feb 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role Of Ultrasonography Compared To MR Imaging In Assessment Of Tempromandibular Joint Disorders
- ClinicalTrials.gov ID
- NCT05320770
- Acronym / sponsor ID
- Soh-Med-22-02-05
- Conditions
- TMJ Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMD patients with joint hyper mobility | Experimental | Procedure: US guided TMJ intra articular injection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| US guided TMJ intra articular injectiontherapeutic TMJ intra articulatr injection of blood under sonography guidance to reduce joint hyper mobility | Procedure or surgery | TMD patients with joint hyper mobility |
Primary outcome
Change of temporomandibular joint imaging by ultrasonography and magnetic resonance imaging .
Time frame: Ultrasonography at baseline visit and MRI one week after baseline visit .
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 .
Time frame: Baseline visit and three months after the baseline intervention .
Measuring the temporomandibular joint mobility in millimeters by ultrasonography before and after sonar guided injection .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing US guided TMJ intra articular injection in people with TMJ Disorder, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aliaa M Awad (01201240011, aliaa011119@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of temporomandibular joint imaging by ultrasonography and magnetic resonance imaging . (time frame: Ultrasonography at baseline visit and MRI one week after baseline visit .). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.