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

Le Fort; I Clinical Trial

Official title:

Assessment Of Computer-Aided Design/Manufacturing for Le Fort I Osteotomy and 3D-customized Titanium Plate in Orthognathic Surgery (Clinical Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06317012
• Other study ID #: 0407-03/2022
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: March 2024
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Le Fort; I

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain	pain will be scored using visual analogue scale. it ranges from 0 to 10, 0 mean no pain and 10 means severe pain	2nd and 7th days
Primary	change in edema	it was evaluated by its ability to pit. The examiner's fingers will press into the dependent area for 5 seconds, and the pitting will be graded on a scale of +1 to+4.	2nd and 7th days
Primary	Change in post operative osteotomy position	Computed tomography (CT) will be used immediately postoperative to assess surgical position by comparing the clinical results with the virtually planned outcome.	Immediate post operative