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CompletedNCT07266714RCTUpdated Dec 5, 2025

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

An interventional study of Ultrasound guided injection with hyaluronic acid and Conventional in Anterior Disk Displacement TMJ, sponsored by Muhannad. Completed at 1 site in Egypt. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-12-05.

Sponsored by Muhannad · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Sep 2024, registered Nov 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Anterior Disk Displacement TMJ

Keywords

  • Temporomandibular Joint, Disc displacement with reduction, Ultrasound, Hyaluronic acid.
03

In context

Lead sponsor

This is the only study on the registry with Muhannad as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Patient with an inflammatory or connective tissue disease
  2. Patient with previous invasive TMJ surgical procedure.
  3. Patient with Neurologic disorders
  4. History of injection of any substance into the target TMJ during previous 6 months.
  5. Patient with a history of bony adhesion.
  6. Malignant disease in the head and neck region.
  7. Patient with a psychological problem.
  8. Patients having gross mechanical restrictions and condylar fracture
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Ultrasound guided itra-articular injection of hyaluronic acid

    Device: Ultrasound guided injection with hyaluronic acid

  • Experimental
    Conventional intra-articular injection of hyaluronic acid

    Other: Conventional

Interventions

  • DeviceUltrasound guided injection with hyaluronic acid

    Ultrtasound Guided injection of Hyaluronic Acid

  • OtherConventional

    Conventional injection of hyaluronic Acid

06

What researchers measure

Primary outcomes

  1. Pain (Visual Analogue Scale)

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

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

  2. Clicking sound

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

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

  3. Maximum inter-incisal opening (MIO)

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

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

  4. Range of lateral mandibular excursions

    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

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

07

Study locations

1 site
  • Mansoura University
    Al Mansurah, Dakahlia Governorate 14323, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07266714
Lead sponsor
Muhannad
Collaborators
Mansoura University
Responsible party
Muhannad (B.D.S( Aljouf University, 2021. Sakaka, KSA) Master Dgree at Oral surgery department (2022) Affiliation: Mansoura University, Mansoura University) — Sponsor-investigator
First posted
Dec 5, 2025
Start date
Sep 1, 2024
Primary completion
Jul 30, 2025
Completion
Sep 30, 2025
Last update
Dec 5, 2025

Study contacts

Sally Elsayed Abdelsameaa, Assistant Professor
principal investigator · Mansoura University
Muhammad Adel Al-Hawari, Lecturer
principal investigator · Mansoura University
Ayman Ahmed Yaseen, Lecturer
principal investigator · Mansoura University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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