Intra-articular Injection in Arthroscopic Management of Temporomandibular Diseases

Study Overview
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Brief Summary
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The aim of this study is to evaluate the efficacy of intra-articular injection of platelet rich plasma versus hyaluronic acid following diagnostic arthroscopy in the management of patients suffering from degenerative temporomandibular joint (TMJ). This is a prospective randomized study of 20 patients with TMJ degenerative joint diseases Wilkes IV, V. Patients will be divided into two groups; Group A: will be treated with operative arthroscopy plus intra-articular platelet rich plasma. Group B: will be treated with operative arthroscopy plus intra-articular hyaluronic acid.

Official Title
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Comparative Study Between the Outcome of Intra-articular Injection of Platelet Rich Plasma Versus Hyaluronic Acid in Arthroscopic Management of Temporomandibular Degenerative Joint Diseases: A Randomized Clinical Trial

Conditions
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Temporomandibular Joint Disorders

Intervention / Treatment
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* Procedure: Temporomandibular joint arthroscopy plus intra-articular injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - All patients with reduced mouth opening and/or painful maximum mouth opening. Joint pain. Patients with radiological evidence of degenerative joint disease. Patients with unsuccessful medical conservative treatment for at least two months. Unilateral or bilateral temporomandibular joint involvement. Wilkes stages IV and V Exclusion Criteria: - Patients with bony ankylosis . Patients with advanced resorption of the glenoid fossa. Patients with infection or tumors around joint area Patients unfit for intervention medically. Patients who refused to share in the study

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: arthroscopy plus platelet rich plasma.<br>Group A: will be treated with operative arthroscopy plus intra-articular injection of platelet rich plasma | Procedure: Temporomandibular joint arthroscopy plus intra-articular injection<br>* patients with TMJ degenerative joint diseases Wilkes stages IV, V not responding to conservative treatment will undergo operative diagnostic arthroscopic treatment then at the end of the procedure intra-articular injection of platelet rich plasma or hyaluronic acid will be done.<br>|
| Active Comparator: arthroscopy plus hyaluronic acid.<br>Group B: will be treated with operative arthroscopy plus intra-articular injection of hyaluronic acid | Procedure: Temporomandibular joint arthroscopy plus intra-articular injection<br>* patients with TMJ degenerative joint diseases Wilkes stages IV, V not responding to conservative treatment will undergo operative diagnostic arthroscopic treatment then at the end of the procedure intra-articular injection of platelet rich plasma or hyaluronic acid will be done.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in maximum inter-incisal mouth opening | change in maximum inter-incisal mouth opening will be measured in millimeters | change from baseline maximum interincisal mouth opening in millimeters at 6 months postoperative | 
| Change in pain intensity | A 100 -point visual analogue scale (VAS) for the assessment of pain intensity with 0 as the absence of pain and 100 as the worst pain imaginable With filled standardized charts. | change from preoperative pain intensity according to 100 -point visual analogue scale at 6 months postoperative |