Computer Guided Single Needle Arthrocentesis

Alexandria University

Status: Active, not recruiting

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

Treatments: Device: Computer-guided single needle arthrocentesis; Device: conventional free hand single needle arthrocentesis

Study type: Interventional

Funder types: Other

Identifiers

NCT07306936

12-12-25-RE-Shepared

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

Device: Computer-guided single needle arthrocentesis

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

Placebo Comparator group

Description:

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

Treatment:

Device: conventional free hand single needle arthrocentesis