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Accuracy of LeFort I Osteotomy Fixation Using Two Plates Versus Four Plates Patient Specific Osteosynthesis

NCT05908370 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-06-18

No results posted yet for this study

Summary

Virtual Surgical planning (VSP) has significantly improved many aspects of oral and maxillofacial surgery. A very important aspect is surgical accuracy and precise transfer of the surgical plan to the operating theatre and reduction of operative time. Conventional treatment planning for orthognathic surgery, although proven to be reliable, has many drawbacks. Computer guided splintless maxillary orthognathic surgery has been recently performed with predictable outcomes. More than one design of PS osteosynthesis has been used in recent trials. Nevertheless, which design is more superior to the other is a topic yet to be addressed. Either a one-piece fixation device spanning the length of the Le Fort 1 osteotomy or the fixation can be provided by more than one device placed at the load bearing buttresses. The superiority of 4 fixating patients specific plates compared to the other will be determined after evaluating many outcomes including accuracy, intra operative time, post-operative complications.

The goal is to take a step towards determining which design is the best for performing splintless maxillary orthognathic surgery in terms of accuracy and least complications for the correction of prevalent dentofacial deformities.

Beside the evaluation of accuracy, the two different designs will be compared in terms of operative time and post-operative complications.

Conditions

  • Le Fort; I

Interventions

PROCEDURE

Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates)

Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates)

Sponsors & Collaborators

  • Future University in Egypt

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2022-12-30
Completion
2023-01-30

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 NCT05908370 on ClinicalTrials.gov