An interventional study of ultrasound guided autologous blood injection and non guided autologous blood injection in Temporomandibular Joint Dislocation, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-06.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
The aim of this study is To compare the accuracy and effectiveness of ultrasound (US) guided autologous blood injection (ABI) versus non- guided technique for the treatment of chronic recurrent temporomandibular joint dislocation
All patients involved in this study will be divided randomly to two different groups and injected with autologous blood into joint space and pericapsular tissue.
Study group (group A) will be injected with autologous blood with ultrasound guidance.
control group (group B) will be injected with autologous blood without US guidance. Anatomical landmarks and tactical sense will be followed only.
The operation will be done under local anesthesia ( Auriculotemporal nerve block ) the skin overlying the temporomandibular joint will be scrubbed by an antiseptic solution and the area will be isolated with sterile towels. External auditory canal will be blocked with cotton.
About 3 ml of blood will be withdrawn from patient's antecubital fossa, of which 2 ml injected intra-articular and 1 ml in the pericapsular tissue (PT) The procedure should be repeated on the opposite side in case of bilateral involvement.
98 studies on the registry are indexed under Joint Dislocations; 21 are open to participants now.
This study's planned enrollment of 24 is below the median of 50 across 60 interventional studies indexed under Joint Dislocations.
Browse Joint Dislocations studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
uses of ultrasound as a guiding tool for temporomandibular joint injection
Procedure: ultrasound guided autologous blood injection
without ultrasound guidance only anatomical landmark will be followed during injection
Procedure: non guided autologous blood injection
guided
non guided
maximum mouth opening
change in Maximum mouth opening (MMO): It's measured (in millimeter) from incisal edge of 11 to 41, in maximum mouth open position using caliper
Time frame: at 2weeks, 3months and 6 months post-operative
Frequency of temporomandibular joint dislocation:
number of dislocation per week
Time frame: 2weeks, 3 months and 6 months post-operatively
change of pain
measuring pain using visual analogue scale(0-10),higher scores mean worse outcome.
Time frame: 2weeks, 3 months and 6 months post-operatively
Started Jan 2024 (actual). Primary completion is estimated for Jul 2024, 6 months after the start.
Of 24 interventional studies with no phase under Joint Dislocations, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 68. This study's planned 6 months is below that.
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