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Completed

NCT Number: NCT07750483

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

About this study

Temporomandibular joint (TMJ) internal derangement is a common disorder associated with pain, joint sounds, and limitation of mandibular function. Although conservative treatment is considered the first-line therapy, some patients continue to experience persistent symptoms requiring minimally invasive intervention.

Hyaluronic acid (HA) is widely used for intra-articular injection because of its lubricating and anti-inflammatory properties. Platelet-rich plasma (PRP) has demonstrated regenerative potential through the release of growth factors that may promote tissue healing. Corticosteroids provide potent anti-inflammatory effects but may adversely affect cartilage with repeated use, whereas tenoxicam is a long-acting nonsteroidal anti-inflammatory drug with favorable analgesic and anti-inflammatory properties.

This prospective randomized controlled clinical trial will compare three treatment protocols:

Hyaluronic acid combined with tenoxicam Hyaluronic acid combined with platelet-rich plasma Hyaluronic acid combined with corticosteroid

Sixty patients diagnosed with TMJ internal derangement with reduction confirmed by MRI and unresponsive to conservative treatment will be randomly allocated in a 1:1:1 ratio to one of the three intervention groups. Clinical assessments will include pain intensity using the Visual Analog Scale (VAS), maximum mouth opening (MMO), and joint clicking at baseline, 1 week, 1 month, 3 months, and 6 months. MRI examinations will be performed at baseline and 6 months to evaluate structural changes within the joint

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Joint Clicking

    Time frame: Baseline, 1 week, 1 month, 3 months, and 6 months

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

  2. MRI Evaluation

    Time frame: Baseline and 6 months

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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Acronym: MRI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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