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Clinical Trials/NCT04936945
NCT04936945
Unknown
Not Applicable

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

Sohag University1 site in 1 country20 target enrollmentJune 13, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Temporomandibular Joint Disorders
Sponsor
Sohag University
Enrollment
20
Locations
1
Primary Endpoint
Maximum Interincisal Opening (MIO) Measurements
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 13, 2021
End Date
June 1, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmad Mohammad Abd-elmoniem

Principal Investigator

Sohag University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Maximum Interincisal Opening (MIO) Measurements

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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