TMJ - Oral &Maxillofacial Surgery
Conditions
Brief summary
The aim of the study is to evaluate the applicability, accuracy, benefits and the efficacy of 3-dimensional, printed, patient-specific guides to direct TMJ access for arthrocentesis when performed in contrast with conventional arthrocentesis of TMJ.
Interventions
PROCEDUREComputer Guided Arthrocentesis
patients are going to be injected intra-articular within the superior joint space of the affected TMJ through custom guided template planned in a manner inspired by earphone design to get support from the tragus.
PROCEDUREConventional Arthrocentesis
patients are going to be injected intra-articular within the superior joint space of the affected TMJ using conventional method anatomical landmark determination
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients who complain from signs and symptoms of internal derangements and were diagnosed by the RDC/TMD as having disc displacement with/ without reduction with / without limitation associated with arthralgia or as having disc displacement with reduction associated with arthralgia in a presence or absence of joint sounds. * Patients who did not responded to conservative treatment for a minimum of 3 months. * Obtaining written informed consents signed by the patients.
Exclusion criteria
* Patients suffering from any muscular disorders as myofascial pain or myofascial pain with limitations * If the disc was not visible in the MRI examination. * Patients who previously received intra-articular injection of any medication or exposed to any other TMJ invasive procedure. * Patients who suffer from any connective tissue diseases as rheumatoid arthritis or neurologic disorders. * Patients with history of major jaw trauma, bisphosphonate-derived drug use, pregnancy, alcohol or drug dependence. * Patients with gross mechanical restrictions or history of adhesion (fibrous or bony). * Patients with psychiatric disease or substance abuse or have an allergy to the substance used in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Attempts number of needle puncture | intraoperative |
| Operation time started from first needle insertion. | intaoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum mouth opening | 1week, 1, 3 and 6 | Change of mouth opening measurement using RDC/TMD |
| Pain reduction | 1week, 1, 3 and 6 | Pain assessment using Visual analogue Scale |
Countries
Egypt
Outcome results
None listed