An interventional study of Computer-guided single needle arthrocentesis and conventional free hand single needle arthrocentesis in Temporomandibular Disorder (TMD), Internal Derangement and Anterior Disc Displacement, sponsored by Alexandria University. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by Alexandria University · Not applicable, Interventional, and Treatment
The intra-articular injection is considered the first line of minimally invasive treatment in temporomandibular joint with internal derangement (TMJ-ID) patients who do not respond to conservative treatment. The single-needle technique arthrocentesis has emerged to add reliability, convenience, ease the performance of the procedure, and eliminate the need for multiple punctures the Aim of this study is to assess clinical applicability and therapeutic outcomes of computer guided single needle arthrocentesis with platelet rich plasma using Shepard's cannula, in comparison with conventional free-hand technique, in the management of disc displacement with reduction of the TMJ.
A total of 24 patients with a magnetic resonance imaging (MRI) diagnosis of reducing disc displacement will be included and assigned randomly into one of two groups. Computer-guided arthrocentesis with PRP will be performed on patients in the study group using the single needle technique by Shepard cannula technique; while the conventional free hand technique will be performed in the control group. Procedure-related parameters will be assessed, while Clinical evaluation will be conducted on day 1, 1 and 3 months postoperatively.
609 studies on the registry are indexed under Temporomandibular Joint Disorders; 160 are open to participants now.
This study's enrollment of 24 is below the median of 46 across 434 interventional studies indexed under Temporomandibular Joint Disorders.
Browse Temporomandibular Joint Disorders studies →Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients with TMJ ID + reduction managed with computer-guided single needle arthrocentesis in adjunct to PRP intra-articular injection.
Device: Computer-guided single needle arthrocentesis
Patients with TMJ ID + reduction managed with conventional free hand single needle arthrocentesis in adjunct to PRP intra-articular injection
Device: conventional free hand single needle arthrocentesis
Patients with TMJ ID + reduction managed with computer-guided single needle arthrocentesis in adjunct to PRP intra-articular injection
Patients with TMJ ID + reduction managed with conventional free hand single needle arthrocentesis in adjunct to PRP intra-articular injection.
objective assessment of joint function and mandibular excursion
Clinical evaluation will be based on the Helkimo's clinical dysfunction index (Di), which is a part of the Helkimo index that provides an objective assesment of joint function and mandibular excursion. All patients will be assessed immediately post-operative, 1 and 3 months. Postoperative clinical evaluation values will be compared to the preoperative baseline preoperative values.
Time frame: 3 months
Duration of the Operation
Total procedural time consumed starting from the application of topical antiseptic up to the end of the procedure will be measured and compared between both groups. In the Computer-Guided group, the time for needle injection will be further computed to determine the actual injection time in the procedure bar from the guide installation time and patient preparation.
Time frame: intraoperative
Plan to share: No — all data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study
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This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Temporomandibular Joint Disorders→
Alexandria University