Intra-articular Injection in Arthroscopic Management of Temporomandibular Diseases

Temporomandibular Joint Disorders Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04936945
• Other study ID #: Soh-Med-21-06-15
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2021
• Source: Sohag University
• Contact: Ahmad M Abdel-moniem, MS
• Phone: 01024942844
• Email: ahmed.abdelaal1[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 1, 2023
• Est. primary completion date: June 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Procedure:
• Temporomandibular joint arthroscopy plus intra-articular injection
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.

Locations

Country	Name	City	State
Egypt	Sohag University	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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