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

Primary Purpose

Temporomandibular Joint Disorders, Temporomandibular Disorder

Status

Unknown status

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Hypertonic Dextrose Solution

Liquid Phase Concentrated Growth Factor (LPCGFs)

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hypertonic Dextrose Solution

Liquid Phase Concentrated Growth Factor (LPCGFs)

Arm Description

Outcomes

Primary Outcome Measures

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.

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

Myeloperoxidase enzyme activity

This will be evaluated by using Myeloperoxidase enzyme assay kits for detection and quantitation of myeloperoxidase activity levels.

Secondary Outcome Measures

Full Information

NCT ID

NCT04557878

First Posted

September 15, 2020

Last Updated

September 15, 2020

Sponsor

Nourhan M.Aly

Collaborators

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT04557878

Brief Title

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

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 6, 2020 (Anticipated)

Primary Completion Date

April 2021 (Anticipated)

Study Completion Date

June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nourhan M.Aly

Collaborators

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Temporomandibular Joint Disorders, Temporomandibular Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hypertonic Dextrose Solution

Arm Type

Experimental

Arm Title

Liquid Phase Concentrated Growth Factor (LPCGFs)

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Hypertonic Dextrose Solution

Intervention Description

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

Biological

Intervention Name(s)

Liquid Phase Concentrated Growth Factor (LPCGFs)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Maximum mouth opening

Description

Time Frame

up to 6 months

Title

Disc-condyle relationship

Description

This will be evaluated using magnetic resonance imaging (MRI) to assess the position of the articular disc and the condyle and the mandibular fossa

Time Frame

6 months

Title

Myeloperoxidase enzyme activity

Description

This will be evaluated by using Myeloperoxidase enzyme assay kits for detection and quantitation of myeloperoxidase activity levels.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mariam Bahgat, M.Sc

Phone

01222882107

Ext

First Name & Middle Initial & Last Name or Official Title & Degree

Nourhan M. Aly, M.Sc

Phone

01006639489

Ext

nourhan.moustafa@alexu.edu.eg

Overall Study Officials: