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

NCT05908370 | Completed DMC

• 1 other identifier: (25)11-2021
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Le Fort; I

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

EXPERIMENTAL

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

Maxillary orthognathic surgery using 2 patient specific osteosynthesis (2-Plates)

NO INTERVENTION

Interventions

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)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Faculty of Oral and Dental Medicine, Future Univerisity in Egypt

Cairo, 11835, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Candidate at the Faculty of Oral and Dental Medicine, Future University in Egypt

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 18, 2023
• Study Start: January 1, 2022
• Primary Completion: December 30, 2022
• Study Completion: January 30, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

EG (1)