Intra-articular Injection in Arthroscopic Management of Temporomandibular Diseases

Not Applicable

• Conditions: Temporomandibular Joint Disorders
• Interventions: Procedure: Temporomandibular joint arthroscopy plus intra-articular injection

• Registration Number: NCT04936945
• Lead Sponsor: Sohag University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study Start: 2021-06-13
• Study First Submitted: 2021-06-13
• Study First Submitted QC: 2021-06-18
• Last Update Submitted: 2021-06-18
• Study First Posted: 2021-06-23
• Last Update Posted: 2021-06-23
• Primary Completion: 2022-06-13
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
arthroscopy plus platelet rich plasma.	Temporomandibular joint arthroscopy plus intra-articular injection	Group A: will be treated with operative arthroscopy plus intra-articular injection of platelet rich plasma
arthroscopy plus hyaluronic acid.	Temporomandibular joint arthroscopy plus intra-articular injection	Group B: will be treated with operative arthroscopy plus intra-articular injection of hyaluronic acid

Primary Outcome Measures

Name	Time	Method
Maximum Interincisal Opening (MIO) Measurements	change from baseline maximum interincisal mouth opening in millimeters at 6 months postoperative	change in maximum inter-incisal mouth opening will be measured in millimeters between preoperative and postoperative at 1 week,3 weeks, the every month till 6 months
Pain Intensity Measurements	change from preoperative pain intensity according to 100 -point visual analogue scale at 6 months postoperative	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.

Trial Locations

Locations (1)

Sohag University; 🇪🇬 Sohag, Egypt