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

NCT ID: NCT05908370

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-01-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Future University in Egypt

OTHER

Sponsor Role: lead

Responsible Party

Waleed Hossam Mohamed Sabri Ibrahim

Master Candidate at the Faculty of Oral and Dental Medicine, Future University in Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Oral and Dental Medicine, Future Univerisity in Egypt

Cairo, , Egypt

Countries

Egypt

Other Identifiers

(25)11-2021

Identifier Type: -

Identifier Source: org_study_id