Computer Guided Single Needle Arthrocentesis

NCT07306936 | Active Not Recruiting

• 1 other identifier: 12-12-25-RE-Shepared
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Internal Derangement; Anterior Disc Displacement; Temporomandibular Disorder (TMD)

Keywords

temporomandibular disorder; intra-articular injection; internal derangement; anterior disc displacement; computer-assisted; Computer-aided design; computer-aided manufacturing; software; shepard cannula

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Duration of the Operation

  intraoperative

Study Arms (2)

Patients with TMJ ID + reduction managed with computer-guided single needle arthrocentesis

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Interventions

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.

Patients with TMJ ID + reduction managed with conventional free hand single needle arthrocentesis

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

Patients with TMJ ID + reduction managed with computer-guided single needle arthrocentesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

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

Alexandria, Alexandria Governorate, 21523, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• yehia El-Mahallawy, Phd

  Faculty of Dentistry, Alexandria University, Alexandria, Alexandria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Sequentially numbered, opaque, sealed envelopes (SNOSE) allocation concealment method will be utilized. Each participant included in the study will be given a serial number that will be used in the allocation. These numbers will be written in identical sheets of paper with the group to which each participant is allocated and placed inside opaque envelopes carrying the respective names of participants. A trial independent personnel will be assigned the role of keeping the envelopes and unfolding them only at the time of the operation, so that the participant is allocated to a group which is concealed from the operator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2025
• First Posted: December 29, 2025
• Study Start: April 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: March 1, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)