Treatment of Tempromandibular Joint Anterior Disc Displacement With Different Materials

NCT ID: NCT06441279

Last Updated: 2024-12-04

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

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-10-01

Brief Summary

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

comparing the clinical efficacy of intra-articular injection of platelet lysate (PL), versus Hyaluronic Acid after arthrocentesis in the management of patients with anterior disc displacement with reduction.

Detailed Description

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

Conditions

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

TMJ Disc Disorder

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

Study Groups

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

group 1

30 patients that will have intra-articular injection of 2 ml of Platelet lysate (PL).

Group Type EXPERIMENTAL

intra-articular injection with Platelet lysate (PL).

Intervention Type PROCEDURE

2 ml of Platelet lysate will be deposited into the superior joint space (SJS) in the affected joint at the entry point slowly

group 2

30 patients that will have intra-articular injection of Hyaluronic Acid.

Group Type EXPERIMENTAL

intra-articular injection with Hyaluronic Acid.

Intervention Type PROCEDURE

2 ml of Hyaluronic Acid will be deposited into the superior joint space (SJS) in the affected joint at the entry point slowly.

Interventions

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

intra-articular injection with Platelet lysate (PL).

2 ml of Platelet lysate will be deposited into the superior joint space (SJS) in the affected joint at the entry point slowly

Intervention Type PROCEDURE

intra-articular injection with Hyaluronic Acid.

2 ml of Hyaluronic Acid will be deposited into the superior joint space (SJS) in the affected joint at the entry point slowly.

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* Patients that will be diagnosed with anterior disc displacement with reduction (ADDWR) both clinically and through magnetic resonance imaging scan (MRI).
* Patients who will not respond to a previous conservative therapy.
* Patients with pain in temporomandibular joints.
* Patients with normal or limitation in mouth opening.
* Patients with clicking sound.

Exclusion Criteria

* Patients with previous invasive TMJ surgical procedures.
* Patients with inflammatory or connective tissue diseases.
* Patients with neurologic disorders.
* Patients with history of bony or fibrous adhesion.
* Patients having gross mechanical restrictions and condylar fractures.
* Patients with psychological problems.
* Patients receiving anti-coagulation treatment, non-steroidal anti-inflammatory drugs within 48 hours pre-operatively, corticosteroid injection at the treatment site within one month or systemic use of corticosteroids within 2 weeks.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Heba Elsheikh

Mansoura, Egypt, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A0103024OS

Identifier Type: -

Identifier Source: org_study_id