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NCT Number: NCT04936945

Intra-articular Injection in Arthroscopic Management of Temporomandibular Diseases

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.

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Key information

Conditions

Temporomandibular Joint Disorders Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag University

Sohag, 82525, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Temporomandibular joint arthroscopy plus intra-articular injection

Procedure

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.

Primary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 23, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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