Comparison Between Two Techniques to Reposition the Maxilla After le Fort 1

Not Applicable

Completed

• Conditions: Le Fort; I; Dentofacial Deformities
• Interventions: Procedure: Orthognathic surgery (lefort1)

• Registration Number: NCT06132906
• Lead Sponsor: Alexandria University

Brief Summary

clinical and radiographic comparison between novel locating guide design with pre-bent titanium plates and 3d printed intermediate wafer to reposition the maxilla after Le Fort 1 osteotomy in orthognathic surgery (randomized controlled clinical trial)

Detailed Description

Eligible patients will be allocated randomly into 2 equal groups with 7 patients in each group according to the method that will be used to reposition the maxilla by simple randomization using computer generated random numbers. Group 1 (Study group) will be treated with locating guides to reposition the maxilla with pre-bent plates on 3d model. Group 2 (Control group) will be treated with Intermediate wafer.

Study Timeline

• Study Start: 2022-11-15
• Primary Completion: 2023-10-01
• Status Verified: 2023-11
• Study Completion: 2023-11-01
• Study First Submitted: 2023-11-06
• Study First Submitted QC: 2023-11-09
• Last Update Submitted: 2023-11-09
• Study First Posted: 2023-11-15
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

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

Inclusion Criteria

• All patients requiring Le Fort I osteotomy will be selected including those suffering from skeletal malocclusion (Class II or Class III), midface hypoplasia or vertical maxillary excess.

Exclusion Criteria

cleft lip and palate. skeletal disharmony due to trauma or severe facial asymmetry. significant medical condition.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(Control group) will be treated with Intermediate wafer.	Orthognathic surgery (lefort1)	After le fort 1 osteotomy, Intermediate wafer will be used with intermaxillary fixation.
(Study group) will be treated with locating guides to reposition the maxilla with pre-bent plates	Orthognathic surgery (lefort1)	After le fort 1 osteotomy, locating guides will be used to reposition the maxilla with pre-bent plates.

Primary Outcome Measures

Name	Time	Method
Radiographic evaluation of accuracy by superimposition	2 weeks	Postoperative CBCT was obtained after 2 weeks of surgery for comparison with the expected position of the maxilla in the preoperative virtual plan using 3-matic software in Mimics innovation suite software package. The preoperative planned final maxillary position was compared with the actual postoperative maxillary position by superimposing both STL models on each other with anatomical points along the orbital rims and the zygomatic arch used as reference points for alignment. The N points registration tool was used to obtain the alignment. Afterwards, using trim tool all parts were trimmed except that between the plates and the maxillary teeth crowns. Then the part comparison analysis tool was used to calculate the accuracy of the superimposition of the maxillary segment using point-based analysis algorithm after 2 weeks of surgery for comparison with the expected position of the maxilla in the preoperative virtual plan using Mimics innovation suite software.
The surgery duration	1 week	The time taken between performing the Le fort 1 osteotomy till completion of plate fixation will be measured.

Secondary Outcome Measures

Name	Time	Method
Postoperative Pain	after one week, two weeks	Will be assessed through a 10-point Visual Analogue Scale (VAS)

Trial Locations

Locations (1)

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