Clinical trial NCT04557878: Role of Liquid Phase Concentrated Growth Factors vs. Hypertonic Dextrose Prolotherapy for Management of Patients With Disc Displacement Without Reduction
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Temporomandibular Joint Disorders
Temporomandibular Disorder
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2020-09-22
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum mouth opening
timeFrame: up to 6 months
measure: Disc-condyle relationship
timeFrame: 6 months
measure: Myeloperoxidase enzyme activity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Mariam M. Bahgat, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Nadia R El-Helw, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Ahmed Abdelhamid, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Mohamed Fata, PhD
role: STUDY_DIRECTOR
affiliation: High Institute of Public Health, Alexandria University
name: Medhat Ashour, PhD
role: STUDY_DIRECTOR
References: