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

N

Nourhan M.Aly

Status and phase

Completed
Phase 2

Conditions

Temporomandibular Joint Disorders
Temporomandibular Disorder

Treatments

Drug: Hypertonic Dextrose Solution
Biological: Liquid Phase Concentrated Growth Factor (LPCGFs)

Study type

Interventional

Funder types

Other

Identifiers

NCT04557878
LPGF vs hypertonic dextrose

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

24 participants in 2 patient groups

Hypertonic Dextrose Solution
Experimental group
Treatment:
Drug: Hypertonic Dextrose Solution
Liquid Phase Concentrated Growth Factor (LPCGFs)
Active Comparator group
Treatment:
Biological: Liquid Phase Concentrated Growth Factor (LPCGFs)

Trial contacts and locations

1

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Central trial contact

Mariam Bahgat, M.Sc; Nourhan M. Aly, M.Sc

Data sourced from clinicaltrials.gov

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