Treatment of Tempromandibular Joint Anterior Disc Displacement With Different Materials

NCT06441279 — Not applicable, Completed, 60 participants, Mansoura University

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

Registry	NCT06441279
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	60 (Actual)
Sponsor	Mansoura University (Other)
Conditions	TMJ Disc Disorder
Interventions	intra-articular injection with Platelet lysate (PL)., intra-articular injection with Hyaluronic Acid. (Procedure)
Dates	start 2024-04-01, primary completion 2024-10-01, completion 2024-10-01, first posted 2024-06-04, last updated 2024-12-04
Locations	1 site in Egypt

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
group 1	Experimental	Procedure: intra-articular injection with Platelet lysate (PL).	30 patients that will have intra-articular injection of 2 ml of Platelet lysate (PL).
group 2	Experimental	Procedure: intra-articular injection with Hyaluronic Acid.	30 patients that will have intra-articular injection of Hyaluronic Acid.

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.

+Outcome measures

Primary outcomes

Maximum inter-incisal opening [6 months]: Maximum inter-incisal opening will be measured by Vernier caliper and this will be recorded by photographs.

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Heba Elsheikh	Mansoura, Egypt	Egypt

+Publications

Results publication: Elsheikh HA, Abdel-Rahman FH, Khaled N, Abdelsameaa SE. Platelet lysate versus hyaluronic acid after arthrocentesis in the treatment of temporomandibular joint anterior disc displacement with reduction: a randomized clinical trial. Odontology. 2026 Apr 30. doi: 10.1007/s10266-026-01397-1. Online ahead of print. PMID 42062696