Computer Guided Single Needle Arthrocentesis

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Internal Derangement; Anterior Disc Displacement; Temporomandibular Disorder (TMD)
• Intervention / Treatment: Device: Computer-guided single needle arthrocentesis; Device: conventional free hand single needle arthrocentesis

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria Governorate
    • Alexandria, Alexandria Governorate, Egypt, 21523
      • Outpatient clinics of Faculty of Dentistry, Alexandria University, Egypt Alexandria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with Wilkes stage III, IV, V.
2. Patients suffering from any systemic diseases, platelets function disorders, fibrinogen deficiency.
3. History of mandibular fracture.
4. Lactating, pregnant or planning pregnancy women.
5. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with TMJ ID + reduction managed with computer-guided single needle arthrocentesis; 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 computer-guided single needle arthrocentesis in adjunct to PRP intra-articular injection
Placebo Comparator: Patients with TMJ ID + reduction managed with conventional free hand 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 conventional free hand single needle arthrocentesis in adjunct to PRP intra-articular injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	intraoperative

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: yehia El-Mahallawy, Phd, Faculty of Dentistry, Alexandria University, Alexandria, Alexandria

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Actual): November 30, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: December 13, 2025
• First Submitted That Met QC Criteria: December 13, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: temporomandibular disorder; software; computer-assisted; intra-articular injection; internal derangement; Computer-aided design; computer-aided manufacturing; anterior disc displacement; shepard cannula
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Muscular Diseases; Joint Diseases; Jaw Diseases; Mandibular Diseases; Craniomandibular Disorders; Temporomandibular Joint Disorders
• Other Study ID Numbers: 12-12-25-RE-Shepared

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No