Intra-articular Injection in Arthroscopic Management of Temporomandibular Diseases

Sponsor

Sohag University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04936945

Collaborator

(none)

Enrollment

Location

Arms

23.6

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Temporomandibular Joint Disorders	Procedure: Temporomandibular joint arthroscopy plus intra-articular injection	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 13, 2021

Anticipated Primary Completion Date :

Jun 13, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: arthroscopy plus platelet rich plasma. Group A: will be treated with operative arthroscopy plus intra-articular injection of platelet rich plasma	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.
Active Comparator: arthroscopy plus hyaluronic acid. Group B: will be treated with operative arthroscopy plus intra-articular injection of hyaluronic acid	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.

Arm

Intervention/Treatment

Active Comparator: arthroscopy plus platelet rich plasma.

Group A: will be treated with operative arthroscopy plus intra-articular injection of platelet rich plasma

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.

Active Comparator: arthroscopy plus hyaluronic acid.

Group B: will be treated with operative arthroscopy plus intra-articular injection of hyaluronic acid

Procedure: Temporomandibular joint arthroscopy plus intra-articular injection

Outcome Measures

Primary Outcome Measures

Change in maximum inter-incisal mouth opening [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
Change in pain intensity [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sohag University	Sohag		Egypt	82525

Sponsors and Collaborators

Sohag University

Investigators

Study Chair: Samia M Saied, MD, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmad Mohammad Abd-elmoniem, Principal Investigator, Sohag University

ClinicalTrials.gov Identifier:

NCT04936945

Other Study ID Numbers:

Soh-Med-21-06-15

First Posted:

Jun 23, 2021

Last Update Posted:

Jun 23, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Joint Diseases

Temporomandibular Joint Disorders

Temporomandibular Joint Dysfunction Syndrome

Study Results

No Results Posted as of Jun 23, 2021