About this trial
The use of Ultrasound as a guide in arthrocentesis of tempromandibular joint versus conventional anatomically guided arthrocentesis in treatment of temporomandibular joint internal derangement: A randomized clinical trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged 16 to 45 years of age having temporomandibular joint internal derangement.
Patients free from any systemic conditions and bone metabolic diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
ASA 1-2 patients with no contraindications for GA
Patients who did not respond to conservative treatment.
Disqualifiers
Patient with uncontrolled systemic diseases precluding administration of general anesthesia.
Handicaps and special needs patients.
Prisoners.
Trial design
Parallel
Treatments tested in this trial
Ultrasound guided arthrocentesis of tempromandibular joint
Procedure/Surgery* Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub. * Head turned to the affected side. • External auditory meatus will be blocked with a cotton plug. * Transducer is placed over TMJ, parallel to the long axis of mandibular ramus. • Transducer is tilted until the optimal visualization is obtained. * Disc is visualized as a thin homogenous, hypo-to-iso-echoic band lying adjacent to the inferior relation. The bony landmarks of the mandibular condyle and the articular eminence are visualized as hyperdense lines. * Superior joint space located between the disc and articular eminence is the targeted point of the needle. Intra-operative procedures - continued in both groups: * Lavage is performed with 100 ml of saline solution. * 1 ml of Hyaluronic acid is injected into the superior joint space. * Puncture point is covered with sterile dressing for 24 hours
Conventional anatomically guided arthrocentesis of tempromandibular joint
Procedure/Surgery* Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub. * Head turned to the affected side. • External auditory meatus will be blocked with a cotton plug. * A line will be drawn from tragus of the ear to the outer canthus of the eye with ink. * Double needled canula is inserted into superior compartment of the joint space 2mm below and 10 mm ahead of mid-tragal end of Holmund Hellsing's line. Intra-operative procedures - continued in both groups: * Lavage is performed with 100 ml of saline solution. * 1 ml of Hyaluronic acid is injected into the superior joint space. * Puncture point is covered with sterile dressing for 24 hours
Treatment groups
Trial outcomes
Primary outcomes
Maximum mouth opening
Maximum mouth opening of the patient will be measured in Millimetre (mm) using a ruler
Joint pain
Joint pain: Will be measured by visual analogue scale (VAS) of 10 units according to pre-determined reference values: 0 No pain. 1-2 Faint pain. 3-4 Mild pain 5-6 Moderate pain. 7-8 Severe pain. 9-10 Excruciating pain.
Secondary outcomes
Operation time
Operation time will be measured using stopwatch and recorded in minutes
Locations
Sponsors and contacts
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Samiha Abdelsalam Abdelaziz Abdelaziz
Lead sponsor
Cairo University
Sponsor institution
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