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Skeletal Stability of Le Fort I Osteotomy Using Patient-specific Osteosynthesis Compared to Mini-plate Fixation for Patients With Dentofacial Disharmony

Dentofacial Deformities Clinical Trial

Official title:
Skeletal Stability of Le Fort I Osteotomy Using Patient-specific Osteosynthesis Compared to Mini-plate Fixation for Patients With Dentofacial Disharmony. A Randomized Controlled Clinical Trial

Clinical Trial Summary

The aim of the study is to evaluate the Skeletal stability of Le Fort I osteotomy using patient-specific osteosynthesis compared to Mini-plate fixation for patients with skeletal class III malocclusion.

Clinical Trial Description

postsurgical relapse is one of the most common observations that have been reported after fixation of Le Fort I osteotomy cases. Fixation systems with plates and screws are used in oral maxillofacial surgery for the treatment of facial fractures and orthognathic surgery cases. Although they have been used for decades and have become the standard treatment, the materials used in these systems may fail due to excess loading and other causal factors during the surgical procedure, including failure in plate adaptation and fixation to bone, material design, fabrication, and degree of purity of the plate material. In the fixation system, non-customized plates of standard size are used, and are bent to adapt them to the distances required for planning orthognathic surgeries. Therefore, mandatory use of larger plates than those programmed for use in surgeries is required so that they can be bent to enable insertion. Moreover, there are variations in the number of screws required to retain the plates to enable better fixation. The folds of non-customized plates generate stresses that are minimized when using customized plates, because these plates are fabricated individually, with predetermined sizes for each patient. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05340036
Study type Interventional
Source Cairo University
Contact Hassan Alnimr
Phone +201002961175
Email hassan-fahmy@dentistry.cu.edu.eg
Status Recruiting
Phase N/A
Start date May 26, 2022
Completion date December 2023
View Details
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