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

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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Key information

Conditions

Le Fort; I

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Oral and Dental Medicine, Future Univerisity in Egypt

Cairo, 11835, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients with dentofacial deformity: skeletal class 2, class 3, vertical maxillary excess, Facial asymmetry.
Patient seeking definitive maxillary or bimaxillary surgical correction and refusing orthodontic camouflage.
Patient due to receive a non- segmental Le Fort I osteotomy as part of their orthognathic surgery.
Patient age at least 18 years
Highly motivated patients.
Good oral hygiene.
Patients willing for follow-up, with an informed consent

Exclusion criteria

Medically compromised patients redeeming unfit for general anesthesia
Pregnancy
patient had a known allergy to titanium
Patients with any diseases that may compromise bone or soft tissue healing.
Patients with local pathosis that may interfere with the bone healing.
Patient with previous maxillary surgery having hardware that may compromise accuracy of the virtual planning

Treatment and study plan

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

Procedure

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

Primary outcomes

Accuracy

Time frame: 1 week

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.

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

Accuracy of LeFort I Osteotomy Fixation Using Two Plates Versus Four Plates Patient Specific Osteosynthesis. A Randomized Clinical Trial

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2023
First posted: Jun 18, 2023
Registry last updated: Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed