Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06317012
Other study ID # 0407-03/2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03636178 - 3D Evaluation of Nasolabial Changes Following Classic Versus Modified Alar Base Suture After Le Fort I Osteotomy N/A
Completed NCT06132906 - Comparison Between Two Techniques to Reposition the Maxilla After le Fort 1 N/A
Completed NCT06233188 - Effect of Customized Lateral Nasal Wall Osteotomy on the Pterygomaxillary Separation During le Fort I Down-fracture N/A
Completed NCT05908370 - Accuracy of LeFort I Osteotomy Fixation Using Two Plates Versus Four Plates Patient Specific Osteosynthesis N/A