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

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

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.

Study Overview

• Status: Completed
• Conditions: Le Fort; I
• Intervention / Treatment: Procedure: Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates)

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11835
    • Faculty of Oral and Dental Medicine, Future Univerisity in Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates)	Procedure: Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates); Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates)
No Intervention: Maxillary orthognathic surgery using 2 patient specific osteosynthesis (2-Plates)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 week

Collaborators and Investigators

• Sponsor: Future University in Egypt

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: May 29, 2023
• First Submitted That Met QC Criteria: June 9, 2023
• First Posted (Estimated): June 16, 2023

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: (25)11-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No