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

NCT06317012 | Completed

• 1 other identifier: 0407-03/2022
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Le Fort I osteotomy

EXPERIMENTAL

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

Interventions

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

Le Fort I osteotomy

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: May 1, 2022
• Primary Completion: May 30, 2023
• Study Completion: June 30, 2023
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

EG (1)