Role of Liquid Phase Concentrated Growth Factors vs. Hypertonic Dextrose Prolotherapy for Management of Patients With Disc Displacement Without Reduction

Temporomandibular Disorder Clinical Trial

Official title:

Role of Liquid Phase Concentrated Growth Factors vs. Hypertonic Dextrose Prolotherapy for Management of Patients With Disc Displacement Without Reduction (A Randomized Clinical Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04557878
• Other study ID #: LPGF vs hypertonic dextrose
• Status: Completed
• Phase: Phase 2
• Start date: October 6, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: December 2023
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Purpose of the study is to compare clinically, radiographically and biochemically the effect of intra- articular injection of hypertonic dextrose with a stabilization appliance and the intra- articular injection of 2 ml of liquid phase concentrated growth factor with a stabilization appliance as a prolotherapy for temporomandibular joint anterior disc displacement without reduction.

Description:

Twenty four patients with anterior disc displacement without reduction will be selected from those attending the Prosthodontic Department, Faculty of Dentistry, Alexandria University and diagnosed clinically and by magnetic resonance imaging. Patients will be randomly assigned into 2 study groups each comprising 12 patients. Group I will receive an intra-articular injection of hypertonic dextrose in conjugation with a maxillary CAD/CAM full-arch hard clear acrylic stabilization appliance while group II will receive an intra-articular injection of LPCGF in conjugation with a maxillary CAD/CAM full-arch hard clear acrylic stabilization appliance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Patients with painful TMJ.
• Patients with limited mouth opening (MMO <40mm).
• Patients with anterior disc displacement without reduction confirmed by MRI.
• Presence of full or nearly full complement of natural teeth.
• Patients with angle class I occlusion.
• Patients with RCP not greater than 2mm and with no open bite.

Exclusion Criteria:

• Patients who have anterior disc dislocation with reduction detected by MRI.
• Inability or unwillingness to undergo magnetic resonance imaging (MRI) such as implanted electronic devices.
• Patients having uncontrolled systemic disease, hematologic or neurologic disorders or inflammatory diseases.
• Patients under anticoagulant drug therapy.

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Drug:
• Hypertonic Dextrose Solution
Patients in this group will receive an intra-articular injection of 12.5% hypertonic dextrose solution, once every month for three consecutive months, in conjugation with a maxillary CAD/CAM full-arch hard clear acrylic stabilization appliance.The point of needle entry will be 1 cm below the apex of the zygomatic arch and guided by ultrasound to ensure intra-articular injection in the superior joint space.

Biological:
• Liquid Phase Concentrated Growth Factor (LPCGFs)
Patients in this group will receive single intra-articular injection of LPCGF in conjugation with a maxillary CAD/CAM full-arch hard clear acrylic stabilization appliance.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Nourhan M.Aly	Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum mouth opening	This will be evaluated using Helkimo Anamnestic index (Ai) which comprises the following classes: Ai0 - absence of subjective symptoms of dysfunction; AiI -mild symptoms, such as TMJ sounds, including clicking and crepitation, and feelings of stiffness or fatigue of the jaws; and AiII - severe symptoms of dysfunction, such as difficulty in opening the mouth wide, locking, luxations, pain on movement, and facial and jaw pain.	up to 6 months
Primary	Disc-condyle relationship	This will be evaluated using magnetic resonance imaging (MRI) to assess the position of the articular disc and the condyle and the mandibular fossa	6 months
Primary	Myeloperoxidase enzyme activity	This will be evaluated by using Myeloperoxidase enzyme assay kits for detection and quantitation of myeloperoxidase activity levels.	6 months