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

NCT ID: NCT04557878

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-06

Study Completion Date

2021-06-01

Brief Summary

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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

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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

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Temporomandibular Joint Disorders Temporomandibular Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Hypertonic Dextrose Solution

Group Type EXPERIMENTAL

Hypertonic Dextrose Solution

Intervention Type DRUG

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.

Liquid Phase Concentrated Growth Factor (LPCGFs)

Group Type ACTIVE_COMPARATOR

Liquid Phase Concentrated Growth Factor (LPCGFs)

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role collaborator

Nourhan M.Aly

OTHER

Sponsor Role lead

Responsible Party

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Nourhan M.Aly

Assistant Lecturer of Dental Public Health

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mariam M. Bahgat, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Alexandria University, Egypt

Nadia R El-Helw, PhD

Role: STUDY_CHAIR

Faculty of Dentistry, Alexandria University, Egypt

Ahmed Abdelhamid, PhD

Role: STUDY_DIRECTOR

Faculty of Dentistry, Alexandria University, Egypt

Mohamed Fata, PhD

Role: STUDY_DIRECTOR

Faculty of Dentistry, Alexandria University, Egypt

Medhat Ashour, PhD

Role: STUDY_DIRECTOR

High Institute of Public Health, Alexandria University

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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LPGF vs hypertonic dextrose

Identifier Type: -

Identifier Source: org_study_id