Temporomandibular Disorder, Temporomandibular Joint Disorders
Conditions
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.
Interventions
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.
BIOLOGICALLiquid 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.
Sponsors
Alexandria University
Nourhan M.Aly
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed