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

Phase 2

Completed

• Conditions: Temporomandibular Joint Disorders; Temporomandibular Disorder
• Interventions: Biological: Liquid Phase Concentrated Growth Factor (LPCGFs); Drug: Hypertonic Dextrose Solution

• Registration Number: NCT04557878
• Lead Sponsor: Nourhan M.Aly

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-22
• Study Start: 2020-10-06
• Primary Completion: 2021-04-01
• Study Completion: 2021-06-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liquid Phase Concentrated Growth Factor (LPCGFs)	Liquid Phase Concentrated Growth Factor (LPCGFs)	-
Hypertonic Dextrose Solution	Hypertonic Dextrose Solution	-

Primary Outcome Measures

Name	Time	Method
Maximum mouth opening	up to 6 months	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.
Disc-condyle relationship	6 months	This will be evaluated using magnetic resonance imaging (MRI) to assess the position of the articular disc and the condyle and the mandibular fossa
Myeloperoxidase enzyme activity	6 months	This will be evaluated by using Myeloperoxidase enzyme assay kits for detection and quantitation of myeloperoxidase activity levels.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt