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NCT Number: NCT07306936

Computer Guided Single Needle Arthrocentesis

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Temporomandibular Disorder (TMD) Anterior Disc Displacement Craniomandibular Disorders Internal Derangement Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient clinics of Faculty of Dentistry, Alexandria University, Egypt Alexandria

Alexandria, Alexandria Governorate, 21523, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with internal derangement according to Wilkes stage I and II.
  • Adult patients above 18 years old.
  • Patients who would not respond to conservative treatment as a first line of treatment

Exclusion criteria

  • Patients with Wilkes stage III, IV, V.
  • Patients suffering from any systemic diseases, platelets function disorders, fibrinogen deficiency.
  • History of mandibular fracture.
  • Lactating, pregnant or planning pregnancy women.
  • Patients receiving anticoagulation treatment or NSAIDS within 48 hours preoperatively, corticosteroid injection at treatment site within 1 month or systemic use of corticosteroids within 2 weeks.

Treatment and study plan

Computer-guided single needle arthrocentesis

Device

Patients with TMJ ID + reduction managed with computer-guided single needle arthrocentesis in adjunct to PRP intra-articular injection

conventional free hand single needle arthrocentesis

Device

Patients with TMJ ID + reduction managed with conventional free hand single needle arthrocentesis in adjunct to PRP intra-articular injection.

Primary outcomes

  1. objective assessment of joint function and mandibular excursion

    Time frame: 3 months

    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.

Secondary outcomes

  1. Duration of the Operation

    Time frame: intraoperative

    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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Computer Guided Single Needle Arthrocentesis With Platelets Rich Plasma Injection in the Management of Temporomandibular Joint Internal Derangement

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 29, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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