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

NCT04557878 | Completed Phase 2

• 1 other identifier: LPGF vs hypertonic dextrose
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Disorders; Temporomandibular Disorder

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Myeloperoxidase enzyme activity

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

  6 months

Study Arms (2)

Hypertonic Dextrose Solution

EXPERIMENTAL

Drug: Hypertonic Dextrose Solution

Liquid Phase Concentrated Growth Factor (LPCGFs)

ACTIVE COMPARATOR

Biological: Liquid Phase Concentrated Growth Factor (LPCGFs)

Interventions

Hypertonic Dextrose Solution 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.

Hypertonic Dextrose Solution

Liquid Phase Concentrated Growth Factor (LPCGFs) 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.

Liquid Phase Concentrated Growth Factor (LPCGFs)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Mariam M. Bahgat, M.Sc

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Nadia R El-Helw, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

• Ahmed Abdelhamid, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY DIRECTOR

• Mohamed Fata, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY DIRECTOR

• Medhat Ashour, PhD

  High Institute of Public Health, Alexandria University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 22, 2020
• Study Start: October 6, 2020
• Primary Completion: April 1, 2021
• Study Completion: June 1, 2021
• Last Updated: December 4, 2023

Record last verified: 2023-12

Locations

EG (1)