Treatment of Tempromandibular Joint Anterior Disc Displacement With Different Materials

NCT06441279 | Completed

• 1 other identifier: A0103024OS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

TMJ Disc Disorder

Outcome Measures

Primary Outcomes (1)

• Maximum inter-incisal opening

  Maximum inter-incisal opening will be measured by Vernier caliper and this will be recorded by photographs.

  6 months

Study Arms (2)

group 1

EXPERIMENTAL

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

Procedure: intra-articular injection with Platelet lysate (PL).

group 2

EXPERIMENTAL

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

Procedure: intra-articular injection with Hyaluronic Acid.

Interventions

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

group 1

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.

group 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Heba Elsheikh

Mansoura, Egypt, 002, Egypt

Location

MeSH Terms

Interventions

Injections, Intra-Articular; Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: April 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

EG (1)