An interventional study of Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates) in Le Fort; I, sponsored by Future University in Egypt. Completed at 1 site in Egypt. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-18.
Sponsored by Future University in Egypt · Not applicable, Interventional, and Treatment
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.
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Procedure: Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates)
Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates)
Accuracy
Primary outcome will be the positional accuracy of the repositioned maxilla which will be measured via CT scan by superimposing the postoperative maxillary segment obtained from a 1-week postoperative CT with the planned one and the difference is calculated in mm.
Time frame: 1 week
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Future University in Egypt