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

Not Applicable

Completed

• Conditions: Orthognathic Surgery
• Interventions: Procedure: Orthognathic surgery (lefort1)

• Registration Number: NCT06188403
• Lead Sponsor: Alexandria University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-15
• Primary Completion: 2023-09-01
• Study Completion: 2023-10-20
• Status Verified: 2023-12
• Study First Submitted: 2023-12-09
• Study First Submitted QC: 2023-12-18
• Last Update Submitted: 2023-12-18
• Study First Posted: 2024-01-03
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(group one) will be treated with custom titanium plates and guide to reposition the maxilla	Orthognathic surgery (lefort1)	7 patients are included in this arm. Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate are placed to reposition the maxilla according to the virtual surgical planning.
(group 2) will be treated with prebent titanium plates	Orthognathic surgery (lefort1)	7 patients are included in this arm. le fort 1 osteotomy using surgical guide and pre-bent stock titanium plates are used after their adaptation on the model of postoperative plan.

Primary Outcome Measures

Name	Time	Method
Radiographic accuracy between postoperative plan and postoperative result.	one month	Cone Beam Computed tomography (CBCT) is used at 1 month to assess surgical outcome by comparing the clinical results with the virtually planned outcome.

Trial Locations

Locations (1)

Alexandria University, Faculty of dentistry; 🇪🇬 Alexandria, Egypt