Custom Made Plate in Orthognathic Surgery

NCT06772688 | Completed

• 1 other identifier: OR SUR-108-2-N
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Maxillary Prognathism; Maxillary Retrusion

Keywords

Orthognathic surgery; Virtual planning; custom made plate

Outcome Measures

Primary Outcomes (1)

• Evaluation of the accuracy of custom-made plate

  CT to measure the accuracy

  immediate postoperative

Study Arms (1)

designing of custom-made plate using 3Dvirtual planning

EXPERIMENTAL

patients underwent maxillary Le Fort I osteotomy using custom made plates for repositioning and fixation.

Procedure: orthognathic surgery

Interventions

orthognathic surgery PROCEDURE

Maxillary repositioning and fixation with custom made plate

designing of custom-made plate using 3Dvirtual planning

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faculty of Dental Medicine for Girls: lead

Study Sites (1)

Faculty of dental medicine Azhar university

Cairo, 12345, Egypt

Location

MeSH Terms

Conditions

Retrognathia

Interventions

Orthognathic Surgery

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Surgery, Oral; Dentistry

Study Officials

• fatma ibrahim

  professor of oral and maxillofacial surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: Fixation of maxilla with custom made plate designed by 3D virtual planning

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 13, 2025
• Study Start: April 3, 2023
• Primary Completion: October 12, 2024
• Study Completion: December 3, 2024
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)