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Computer Guided Single Needle Arthrocentesis

NCT ID: NCT07306936

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Temporomandibular Disorder (TMD) Internal Derangement Anterior Disc Displacement

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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

Study Groups

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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.

Group Type EXPERIMENTAL

Computer-guided single needle arthrocentesis

Intervention Type 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 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

Group Type PLACEBO_COMPARATOR

conventional free hand single needle arthrocentesis

Intervention Type DEVICE

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

Interventions

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Computer-guided single needle arthrocentesis

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

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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yehia El-Mahallawy, Phd

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Alexandria University, Alexandria, Alexandria

Locations

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

Alexandria, Alexandria Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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12-12-25-RE-Shepared

Identifier Type: -

Identifier Source: org_study_id