NCT04557878

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Nourhan M.Aly · Academic / Other
• Sex: All
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Temporomandibular Joint Disorders
• Temporomandibular Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-10-06
• Primary completion: 2021-04-01
• Completion: 2021-06-01
• First posted: 2020-09-22
• Last updated: 2023-12-04

Locations

1 site across 1 country: Egypt