Custom Made Plate in Orthognathic Surgery (OGS)

Evaluation of the Accuracy of Custom-made Plate in Maxillary Repositioning

Orthognathic surgery has traditionally been used to correct dentofacial deformities. Conventional methods rely on 2D radiographic images, occlusal splints, and dental casts, but these approaches have limitations, such as errors during face-bow transfer. Technological advancements, including 3D imaging, virtual surgical planning (VSP), and computer-aided design and manufacturing (CAD/CAM), have improved the precision and outcomes of orthognathic surgery.

Study Overview

• Status: Completed
• Conditions: Maxillary Retrusion; Maxillary Prognathism
• Intervention / Treatment: Procedure: orthognathic surgery

Detailed Description

This study included one group of patients need orthognathic surgery and fixation of maxilla using custom made plate designed by 3D virtual planning using Materialize mimic soft ware

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12345
    • Faculty of dental medicine Azhar university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with skeletal class II or class III who need orthognathic surgery.
• Patients who suffer from clinical facial asymmetry.
• Patients with occlusal plane canting.
• Age range of patients 18-40 years old, with no gender prediction, able to read and sign the informed consent.

Exclusion Criteria:

• Maxillofacial trauma
• Patients who suffer from maxillofacial tumors
• Segmental maxillary surgery.
• Oral soft tissues defects, infections and bone metabolism disturbance.
• Allergy to titanium implant.
• Patient with systemic disease and immunocompromised patient.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: designing of custom-made plate using 3Dvirtual planning; patients underwent maxillary Le Fort I osteotomy using custom made plates for repositioning and fixation.	Procedure: orthognathic surgery; Maxillary repositioning and fixation with custom made plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the accuracy of custom-made plate	CT to measure the accuracy	immediate postoperative

Collaborators and Investigators

• Sponsor: Faculty of Dental Medicine for Girls
• Investigators: Study Director: fatma ibrahim, professor of oral and maxillofacial surgery

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Actual): October 12, 2024
• Study Completion (Actual): December 3, 2024

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Orthognathic surgery; Virtual planning; custom made plate
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Jaw Diseases; Jaw Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Retrognathia; Prognathism
• Other Study ID Numbers: OR SUR-108-2-N

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No