Intra-articular Injection in Arthroscopic Management of Temporomandibular Diseases

NCT04936945 | Completed Results

• 1 other identifier: Soh-Med-21-06-15
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Disorders

Outcome Measures

Primary Outcomes (2)

• Maximum Interincisal Opening (MIO) Measurements

  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

  change from baseline maximum interincisal mouth opening in millimeters at 6 months postoperative

• Pain Intensity Measurements

  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

Study Arms (2)

arthroscopy plus platelet rich plasma.

ACTIVE COMPARATOR

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

Procedure: Temporomandibular joint arthroscopy plus intra-articular injection

arthroscopy plus hyaluronic acid.

ACTIVE COMPARATOR

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

Procedure: Temporomandibular joint arthroscopy plus intra-articular injection

Interventions

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.

arthroscopy plus hyaluronic acid.; arthroscopy plus platelet rich plasma.

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, 82525, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Injections, Intra-Articular

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Magdy Mohamed Amien
• Organization: Soahg University

portal@med.sohag.edu.eg

0934602963

Study Officials

• Samia M Saied, MD

  Professor

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2021
• First Posted: June 23, 2021
• Study Start: June 13, 2021
• Primary Completion: May 12, 2023
• Study Completion: May 16, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)