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

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.

Study Overview

• Status: Completed
• Conditions: Anterior Disk Displacement TMJ
• Intervention / Treatment: Device: Ultrasound guided injection with hyaluronic acid; Other: Conventional

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia Governorate
    • Al Mansurah, Dakahlia Governorate, Egypt, 14323
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound guided itra-articular injection of hyaluronic acid	Device: Ultrasound guided injection with hyaluronic acid; Ultrtasound Guided injection of Hyaluronic Acid
Experimental: Conventional intra-articular injection of hyaluronic acid	Other: Conventional; Conventional injection of hyaluronic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	preoperative and postoerative after 1 week, 3 month and 6 month
Clicking sound	Clicking sound will be assessed as to its presence = 1 or absence = 0.	preoperative and postoerative after 1 week, 3 month and 6 month
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.	preoperative and postoerative after 1 week, 3 month and 6 month
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	preoperative and postoerative after 1 week, 3 month and 6 month

Collaborators and Investigators

• Sponsor: Muhannad
• Collaborators: Mansoura University
• Investigators: Principal Investigator: Sally Elsayed Abdelsameaa, Assistant Professor, Mansoura University; Principal Investigator: Muhammad Adel Al-Hawari, Lecturer, Mansoura University; Principal Investigator: Ayman Ahmed Yaseen, Lecturer, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Temporomandibular Joint, Disc displacement with reduction, Ultrasound, Hyaluronic acid.
• Additional Relevant MeSH Terms: Organizations; Health Care Economics and Organizations; Congresses as Topic
• Other Study ID Numbers: A0109024OS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No