Treatment of Tempromandibular Joint Anterior Disc Displacement With Different Materials

December 3, 2024 updated by: Mansoura University

Hyaluronic Acid Versus Platelet Lysate in The Treatment of Temporomandibular Joint Anterior Disc Displacement With Reduction: A Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, Egypt, 002
        • Heba elsheikh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1
30 patients that will have intra-articular injection of 2 ml of Platelet lysate (PL).
Procedure: 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
Experimental: group 2
30 patients that will have intra-articular injection of Hyaluronic Acid.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum inter-incisal opening
Time Frame: 6 months
Maximum inter-incisal opening will be measured by Vernier caliper and this will be recorded by photographs.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

October 1, 2024

Study Completion (Actual)

October 1, 2024

Study Registration Dates

First Submitted

May 29, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

June 4, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0103024OS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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