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

Not Applicable

Completed

• Conditions: Le Fort; I
• Interventions: Procedure: Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate

• Registration Number: NCT06317012
• Lead Sponsor: Hams Hamed Abdelrahman

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-01
• Primary Completion: 2023-05-30
• Study Completion: 2023-06-30
• Status Verified: 2024-03
• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-17
• Last Update Submitted: 2024-03-17
• Study First Posted: 2024-03-19
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Le Fort I osteotomy	Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate	-

Primary Outcome Measures

Name	Time	Method
Change in pain	2nd and 7th days	pain will be scored using visual analogue scale. it ranges from 0 to 10, 0 mean no pain and 10 means severe pain
Change in post operative osteotomy position	Immediate post operative	Computed tomography (CT) will be used immediately postoperative to assess surgical position by comparing the clinical results with the virtually planned outcome.
change in edema	2nd and 7th days	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.

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt