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OpenTrials
Completed

NCT Number: NCT06441279

Treatment of Tempromandibular Joint Anterior Disc Displacement With Different Materials

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.

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Key information

Conditions

TMJ Disc Disorder

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heba Elsheikh

Mansoura, Egypt, 002, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

intra-articular injection with Platelet lysate (PL).

Procedure

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

intra-articular injection with Hyaluronic Acid.

Procedure

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 4, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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