Treatment of Tempromandibular Joint Anterior Disc Displacement With Different Materials

TMJ Disc Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06441279
• Other study ID #: A0103024OS
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: Mansoura University
• Contact: heba elsheikh, assistant professor
• Phone: 00201024461010
• Email: heba_elsheikh[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• TMJ Disc Disorder

Intervention

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
• 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.

Locations

Country	Name	City	State
Egypt	Heba Elsheikh	Mansoura, Egypt

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum inter-incisal opening	Maximum inter-incisal opening will be measured by Vernier caliper and this will be recorded by photographs.	6 months