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Completed

NCT Number: NCT07266714

Ultrasound-guided vs Conventional Intraarticular Injection of Hyaluronic Acid for Management of Temporomandibular Joint Internal Derangement

The aim of the study will be to evaluate the clinical efficacy of using ultrasound guidance during intra-articular injection of hyaluronic acid in the management of patients with TMJ internal derangement.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, Dakahlia Governorate, 14323, Egypt

About this study

The temporomandibular joint (TMJ) represents one of the most biomechanically sophisticated and functionally critical articulations in the human body, serving as the primary interface between the mandible and the cranium.

This synovial joint facilitates essential orofacial functions including mastication, phonation, deglutition, and emotional expression through its unique ginglymoarthrodial (hinge-gliding) motion.

Temporomandibular disorders (TMDs) constitute a major public health burden, with epidemiological studies reporting prevalence rates ranging from 5% to 12% in global populations, though subclinical manifestations may affect up to 40% of adults.

The socioeconomic impact is substantial, with chronic TMD patients demonstrating significantly reduced quality-of-life indices comparable to conditions like rheumatoid arthritis, primarily due to persistent pain, functional limitations, and comorbidities with tension-type headaches and sleep disturbances.

Historically, TMJ research evolved from purely mechanical models to contemporary biopsychosocial paradigms that acknowledge multifactorial etiology.

Modern diagnostic frameworks, notably the Diagnostic Criteria for TMD (DC/TMD), emphasize the interplay between articular pathophysiology (e.g., disc displacement, osteoarthritis) and psychosocial dimensions (e.g., catastrophizing, depression), necessitating interdisciplinary management strategies.

Advances in molecular biology have elucidated genetic predispositions (e.g., COMT gene polymorphisms) and inflammatory cascades (IL-1β, TNF-α) that modulate pain sensitization and tissue degeneration.

Concurrently, innovations in diagnostic imaging-particularly dynamic MRI and cone-beam computed tomography (CBCT)-have revolutionized the evaluation of joint kinematics and microarchitecture, enabling earlier detection of degenerative changes.

The clinical management landscape continues to evolve toward minimally invasive biotherapies (e.g., platelet-rich plasma injections) and personalized rehabilitation protocols, though significant challenges persist in predicting treatment responsiveness.

Future research imperatives include validating biomarkers for early TMD detection, optimizing tissue-engineering approaches for condylar regeneration, and integrating artificial intelligence for phenotyping heterogeneous patient subgroups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients that will be diagnosed disc displacement confirmed clinically and by Magnetic Resonance Imaging (MRI).
  • Patient not responding to conservative therapy
  • Patients age must be (18 - 50).
  • Patients having painful joint, clicking sound, with or without limited mouth opening.
  • Patient's ability and desire to complete the treatment protocol and follow-up visits.

Exclusion criteria

  • Patient with an inflammatory or connective tissue disease
  • Patient with previous invasive TMJ surgical procedure.
  • Patient with Neurologic disorders
  • History of injection of any substance into the target TMJ during previous 6 months.
  • Patient with a history of bony adhesion.
  • Malignant disease in the head and neck region.
  • Patient with a psychological problem.
  • Patients having gross mechanical restrictions and condylar fracture

Treatment and study plan

Ultrasound guided injection with hyaluronic acid

Device

Ultrtasound Guided injection of Hyaluronic Acid

Conventional

Other

Conventional injection of hyaluronic Acid

Primary outcomes

  1. Pain (Visual Analogue Scale)

    Time frame: preoperative and postoerative after 1 week, 3 month and 6 month

    Pain intensity will be assessed by visual analog scale (VAS) score. Zero score for no pain and 10 score for worst pain experienced

  2. Clicking sound

    Time frame: preoperative and postoerative after 1 week, 3 month and 6 month

    Clicking sound will be assessed as to its presence = 1 or absence = 0.

  3. Maximum inter-incisal opening (MIO)

    Time frame: preoperative and postoerative after 1 week, 3 month and 6 month

    will be measured by Vernier caliper as the vertical distance in millimeters between the maxillary and mandibular incisal edges of the central incisors.

  4. Range of lateral mandibular excursions

    Time frame: preoperative and postoerative after 1 week, 3 month and 6 month

    will be masseured by Vernier caliper as the horizontal distance in millimeter from maxillary mid line to mandibular mid line with the patient first moving the mandible to one side than to the other at the maximum extend

Sponsors and collaborators

Lead sponsor

Muhannad

Other

Collaborators

  • Mansoura University

Registry information

Acronym: RCT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2025
Registry last updated
Dec 5, 2025

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.