Computer Guided Single Needle Arthrocentesis

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Arthrocentesis With and Without PRP Injection in Patients With Disc Displacement With Reduction.

NCT05983653

TMJ Disc Disorder

COMPLETED NA

a Comparison of the Outcomes Following Intra-articular Dextrose 5% Injection Versus Arthrocentesis in Patients With Anterior Disc Displacement With Reduction of the Tomporomandibular Joint

NCT07129681

TMJ Disc Disorder

NOT_YET_RECRUITING NA

Ultrasound-guided vs Conventional Intraarticular Injection of Hyaluronic Acid for Management of Temporomandibular Joint Internal Derangement

NCT07266714

Anterior Disk Displacement TMJ

COMPLETED NA

MJ Arthrocentesis Using the Dental Implant Motor Irrigation Pump and the Conventional Technique in Treatment of Internal Derangement

NCT07239037

TMJ Disorder

COMPLETED NA

A Prospective Randomized Clinical Trial Comparing a Fast-Fix-Enhanced Arthroscopic System Versus Conventional Arthroscopic Suturing for Temporomandibular Disc Repositioning in Internal Derangement: Functional, Clinical, and Surgical Outcomes

NCT07316673

Temporomandibular Joint Internal Derangement

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Temporomandibular Disorder (TMD) Internal Derangement Anterior Disc Displacement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

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

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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