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Intra-articular Injection in Arthroscopic Management of Temporomandibular Diseases

Primary Purpose

Temporomandibular Joint Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Temporomandibular joint arthroscopy plus intra-articular injection
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sohag UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

arthroscopy plus platelet rich plasma.

arthroscopy plus hyaluronic acid.

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in maximum inter-incisal mouth opening
change in maximum inter-incisal mouth opening will be measured in millimeters
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.

Secondary Outcome Measures

Full Information

First Posted
June 13, 2021
Last Updated
June 18, 2021
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT04936945
Brief Title
Intra-articular Injection in Arthroscopic Management of Temporomandibular Diseases
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 13, 2021 (Actual)
Primary Completion Date
June 13, 2022 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
arthroscopy plus platelet rich plasma.
Arm Type
Active Comparator
Arm Description
Group A: will be treated with operative arthroscopy plus intra-articular injection of platelet rich plasma
Arm Title
arthroscopy plus hyaluronic acid.
Arm Type
Active Comparator
Arm Description
Group B: will be treated with operative arthroscopy plus intra-articular injection of hyaluronic acid
Intervention Type
Procedure
Intervention Name(s)
Temporomandibular joint arthroscopy plus intra-articular injection
Intervention Description
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 Outcome Measure Information:
Title
Change in maximum inter-incisal mouth opening
Description
change in maximum inter-incisal mouth opening will be measured in millimeters
Time Frame
change from baseline maximum interincisal mouth opening in millimeters at 6 months postoperative
Title
Change in pain intensity
Description
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.
Time Frame
change from preoperative pain intensity according to 100 -point visual analogue scale at 6 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmad M Abdel-moniem, MS
Phone
01024942844
Email
ahmed.abdelaal1@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmad M Aggag, MS
Phone
01024942844
Email
ahmad.aggag1990@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samia M Saied, MD
Organizational Affiliation
Professor
Official's Role
Study Chair
Facility Information:
Facility Name
Sohag University
City
Sohag
ZIP/Postal Code
82525
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samia M Saied, MD
Phone
0100291939
Email
ahmad.aggag1990@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intra-articular Injection in Arthroscopic Management of Temporomandibular Diseases

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