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

Not Applicable

Completed

• Conditions: Le Fort; I
• Interventions: Procedure: Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates)

• Registration Number: NCT05908370
• Lead Sponsor: Future University in Egypt

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-12-30
• Study Completion: 2023-01-30
• Study First Submitted: 2023-05-29
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-09
• Last Update Submitted: 2023-06-09
• Study First Posted: 2023-06-18
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Accuracy	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.

Trial Locations

Locations (1)

Faculty of Oral and Dental Medicine, Future Univerisity in Egypt; 🇪🇬 Cairo, Egypt