Computer-Aided Design/Manufacturing for Le Fort I Osteotomy and 3D-customized Titanium Plate in Orthognathic Surgery

NCT ID: NCT06317012

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-06-30

Brief Summary

Background: In orthognathic surgery, virtual planning is gradually taking over in clinical practice. To start with, virtual surgery planning (VSP) is believed to be less time-consuming and less expensive than conventional surgery planning (CSP). Moreover, the improved visualization of craniofacial deformities, such as occlusal canting and asymmetries, is a further advantage. Aim: To assess the result of Le Fort I osteotomy using CAD/CAM and 3Dcustomized titanium plate with virtual planning in orthognathic surgery. Materials and Methods: 8 patients with vertical maxillary excess will be included in the study. Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate will be done for the study group. All patients will be followed clinically and radiographically for one month.

Conditions

Le Fort; I

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Le Fort I osteotomy

Group Type: EXPERIMENTAL

Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate

Intervention Type: PROCEDURE

Le Fort I osteotomy will be performed with the aid of a surgical guide through the mucosal incision at the maxillary vestibule region, providing adequate surgical exposure.

The planned position will be obtained using a customized titanium plate for precise maxillary position and fixation as planned virtually on the software.

Interventions

Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate

Le Fort I osteotomy will be performed with the aid of a surgical guide through the mucosal incision at the maxillary vestibule region, providing adequate surgical exposure.

The planned position will be obtained using a customized titanium plate for precise maxillary position and fixation as planned virtually on the software.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with non-syndromic dentofacial deformity requiring isolated Le Fort I with or without bimaxillary osteotomy.
• Patients with good oral hygiene.
• Class II or III malocclusion.
• Patients who were scheduled to undergo a CT scan as a part of their diagnosis and treatment

Exclusion Criteria

• Patients with acute infection at the surgery site.
• Patient with Systemic disorders contraindicating surgery.
• Smokers.
• Alcohol or drug abuse is prohibited.
• patients who suffered from craniofacial syndrome;
• patients who had previous orthognathic surgery;
• patients who had previous maxillary or mandibular trauma

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hams Hamed Abdelrahman

OTHER

Sponsor Role: lead

Responsible Party

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Alexandria Faculty of Dentistry

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

0407-03/2022

Identifier Type: -

Identifier Source: org_study_id