Comparison Between Prebent Plates and Custom Plates After le Fort 1 in Orthognathic Surgery

Orthognathic Surgery Clinical Trial

— customortho  

Official title:

Comparison of Radiographic Accuracy Between Pre-bent Titanium Plates and 3D Customized Titanium Plates After le Fort 1 Osteotomy in Orthognathic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06188403
• Other study ID #: Orthognathic2
• Status: Completed
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: October 20, 2023

Study information

• Verified date: December 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

patients with dentofacial deformities , who needs lefort 1 osteotomy to correct position of maxilla , are divided into two groups: one group receives custom titanium plates which is patient specific and the other group receives prebent titanium plates done on printed postop plan model before surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 20, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

• . Patients with non-syndromic dentofacial deformity requiring Le Fort I with or without bimaxillary osteotomy.

Exclusion Criteria:

1. Patients with acute infection at surgery site.

2. Patient with Systemic disorders contraindicating surgery.

3. Smokers.

4. Alcohol or drug abuse is prohibited.

5. patients who suffered from craniofacial syndrome.

6. patients who had previous orthognathic surgery.

7. patients who had previous maxillary or mandibular trauma

Related Conditions & MeSH terms

• Orthognathic Surgery

Intervention

Procedure:
• Orthognathic surgery (lefort1)
Lefort 1 osteotomy to reposition the maxilla using two different techniques to achieve more accurate results , one with guide for cutting and placing pre bent stock plates and the other method using custom titanium plates with guide for cutting and placing the plate

Locations

Country	Name	City	State
Egypt	Alexandria University, Faculty of dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic accuracy between postoperative plan and postoperative result.	Cone Beam Computed tomography (CBCT) is used at 1 month to assess surgical outcome by comparing the clinical results with the virtually planned outcome.	one month