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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04557878
Other study ID # LPGF vs hypertonic dextrose
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 6, 2020
Est. completion date June 1, 2021

Study information

Verified date December 2023
Source University of Alexandria
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date June 1, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 40 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Egypt Faculty of Dentistry, Alexandria University Alexandria

Sponsors (2)

Lead Sponsor Collaborator
Nourhan M.Aly Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

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