Correlation Between MRI Findings and Clinical Improvement Following TMJ Injection With Hyaluronic Acid and Platelet-Rich Plasma

NCT07750522 | Completed

• 1 other identifier: R.26.6.122
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Temporomandibular joint (TMJ) disorders can cause jaw pain, clicking sounds, and difficulty opening the mouth, affecting daily activities such as eating and speaking. This study aims to determine whether magnetic resonance imaging (MRI) findings can help predict how much patients improve after a single injection into the TMJ containing hyaluronic acid and platelet-rich plasma (PRP). Adults with TMJ internal derangement who have not improved with conservative treatment will receive one injection of hyaluronic acid combined with PRP prepared from their own blood. Participants will be evaluated before treatment and at follow-up visits over 6 months. Assessments will include pain, jaw function, mouth opening, and MRI scans before and after treatment. The results of this study may improve understanding of the relationship between MRI findings and treatment outcomes and help healthcare providers identify patients who are most likely to benefit from this minimally invasive therapy.

Conditions

TMJ Internal Derangement

Outcome Measures

Primary Outcomes (1)

• Correlation between baseline MRI findings and clinical improvement

  To determine whether baseline magnetic resonance imaging (MRI) findings correlate with and predict clinical improvement following a single intra-articular injection of hyaluronic acid combined with platelet-rich plasma. Clinical improvement will be assessed using pain intensity (Visual Analog Scale), maximum interincisal opening (MIO), and joint clicking. MRI will be repeated at 6 months to evaluate imaging changes.

  Baseline to 6 months

Study Arms (1)

Experimental: Hyaluronic Acid + Platelet-Rich Plasma Injection

EXPERIMENTAL

Participants with MRI-confirmed temporomandibular joint (TMJ) internal derangement with reduction who have failed conservative treatment will receive a single intra-articular injection consisting of 1 mL hyaluronic acid combined with 1 mL autologous platelet-rich plasma (PRP). Participants will be followed for 6 months with clinical assessments and MRI evaluation.

Procedure: intra-articular Injection of Hyaluronic Acid Combined with Platelet-Rich Plasma

Interventions

intra-articular Injection of Hyaluronic Acid Combined with Platelet-Rich Plasma PROCEDURE

Platelet-rich plasma (PRP) will be prepared from 10 mL of the participant's peripheral venous blood using centrifugation. One milliliter of PRP will be mixed with 1 mL of hyaluronic acid and administered as a single intra-articular injection into the affected temporomandibular joint under aseptic conditions. Clinical outcomes (pain intensity, joint clicking, and maximum interincisal opening) will be evaluated at baseline and at 1 week, 1 month, 3 months, and 6 months after treatment. MRI examinations will be performed before treatment and at the 6-month follow-up to assess the relationship between MRI findings and clinical improvement.

Experimental: Hyaluronic Acid + Platelet-Rich Plasma Injection

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Patients age between (18 -45). 2. Early/intermediate stage according to (Wilkes classification). 3. Patients have painful joint, clicking sound, with or without limited mouth opening.
• \. Patients unresponsive to conservative treatment. 5. Patient's ability and desire to complete the treatment protocol and follow up visits.
• \. Patients with internal derangement with reduction confirmed by MRI imaging

You may not qualify if:

• \- 1. Patient with an inflammatory or connective tissue disease 2. Patient with previous invasive TMJ surgical procedure. 3. neurologic disorders 4. History of injection of any substance into the target TMJ during previous 6 months.
• \. Patient with history of bony or fibrous adhesion. 6. Internal derangement without reduction. 7. Patient with psychological problem

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 6, 2026
• Study Start: April 1, 2025
• Primary Completion: April 12, 2026
• Study Completion: April 12, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-08

Locations

EG (1)