Efficacy of Intra-Articular Hyaluronic Acid Combination Injections for Temporomandibular Joint Internal Derangement: A Clinical and MRI Based Randomized Trial

NCT07750483 | Completed

• 1 other identifier: R.26.6.121
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled clinical trial aims to compare the clinical and magnetic resonance imaging (MRI) outcomes of three intra-articular injection protocols for the treatment of temporomandibular joint (TMJ) internal derangement with reduction. Sixty patients who remain symptomatic despite conservative therapy will be randomly assigned to receive hyaluronic acid combined with platelet-rich plasma (PRP), tenoxicam, or corticosteroid. Clinical outcomes including pain intensity, maximum mouth opening, and joint clicking, together with MRI findings, will be evaluated over a 6-month follow-up period.

Conditions

Temporomandibular Joint Internal Derangement

Outcome Measures

Primary Outcomes (2)

• Joint Clicking

  Presence or absence of TMJ clicking will be recorded during mandibular movement.

  Baseline, 1 week, 1 month, 3 months, and 6 months

• MRI Evaluation

  Magnetic resonance imaging will assess changes in disc position, joint morphology, and other structural characteristics following treatment.

  Baseline and 6 months

Study Arms (3)

Hyaluronic Acid + Tenoxicam

EXPERIMENTAL

Participants receive a single intra-articular injection of hyaluronic acid combined with tenoxicam into the affected temporomandibular joint.

Procedure: intraarticular injection in TMJ

Hyaluronic Acid + Platelet-Rich Plasma (PRP)

EXPERIMENTAL

Single intra-articular injection of hyaluronic acid combined with autologous platelet-rich plasma.

Procedure: intraarticular injection in TMJ

hyaluronic acid combined with corticosteroid.

EXPERIMENTAL

Single intra-articular injection of hyaluronic acid combined with corticosteroid.

Procedure: intraarticular injection in TMJ

Interventions

intraarticular injection in TMJ PROCEDURE

Hyaluronic Acid + Tenoxicam: Single intra-articular injection of hyaluronic acid combined with tenoxicam administered to the affected temporomandibular joint. Platelet-Rich Plasma + Hyaluronic Acid: Single intra-articular injection of autologous platelet-rich plasma combined with hyaluronic acid administered to the affected temporomandibular joint. Hyaluronic Acid + Corticosteroid: Single intra-articular injection of hyaluronic acid combined with corticosteroid administered to the affected temporomandibular joint.

Hyaluronic Acid + Platelet-Rich Plasma (PRP); Hyaluronic Acid + Tenoxicam; hyaluronic acid combined with corticosteroid.

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 to 45 years. TMJ internal derangement with reduction confirmed by MRI. Early or intermediate disease according to Wilkes classification. Painful TMJ with clicking, with or without limited mouth opening. Persistent symptoms despite conservative treatment. Able and willing to provide informed consent and attend follow-up visits.

You may not qualify if:

• nflammatory or connective tissue disorders. Previous TMJ surgery. Neurological disorders. Previous TMJ injection within the last 6 months. Fibrous or bony ankylosis/adhesion. Internal derangement without reduction. Psychological disorders affecting study participation.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Location

MeSH Terms

Interventions

Injections, Intra-Articular

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

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: SPONSOR

Model Details: Participants will be randomly assigned to one of three parallel treatment groups in a 1:1:1 ratio.

Study Record Dates

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

Record last verified: 2026-08

Locations

EG (1)