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Clinical Trials/NCT07266714
NCT07266714
Completed
Not Applicable

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

Muhannad1 site in 1 country40 target enrollmentStarted: September 1, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Muhannad
Enrollment
40
Locations
1
Primary Endpoint
Pain (Visual Analogue Scale)

Overview

Brief 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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

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.

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

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Muhannad
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Muhannad

B.D.S( Aljouf University, 2021. Sakaka, KSA) Master Dgree at Oral surgery department (2022) Affiliation: Mansoura University

Mansoura University

Study Sites (1)

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