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

NCT04557878 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-12-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Alexandria University

    collaborator OTHER

  • Nourhan M.Aly

    lead OTHER

Principal Investigators

  • Mariam M. Bahgat, M.Sc · Faculty of Dentistry, Alexandria University, Egypt

  • Nadia R El-Helw, PhD · Faculty of Dentistry, Alexandria University, Egypt

  • Ahmed Abdelhamid, PhD · Faculty of Dentistry, Alexandria University, Egypt

  • Mohamed Fata, PhD · Faculty of Dentistry, Alexandria University, Egypt

  • Medhat Ashour, PhD · High Institute of Public Health, Alexandria University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-06
Primary Completion
2021-04-01
Completion
2021-06-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04557878 on ClinicalTrials.gov