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

Comparison of Accuracy 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

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)

Study Overview

• Status: Completed
• Conditions: Dentofacial Deformities; Le Fort; I
• Intervention / Treatment: Procedure: Orthognathic surgery (lefort1)

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21619
    • Alexandria University, Faculty of dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: (Study group) will be treated with locating guides to reposition the maxilla with pre-bent plates; After le fort 1 osteotomy, locating guides will be used to reposition the maxilla with pre-bent plates.	Procedure: Orthognathic surgery (lefort1); All patients will be treated under general anesthesia.; The surgical field will be scrubbed with povidone-iodine surgical scrub solution, followed by draping of the patient with sterile towels exposing only the area of surgery.; The surgical procedure of Le Fort I osteotomy will be performed which can be summarized as follows:External reference markingIncision and subperiosteal dissectionMaxillary osteotomyPterygomaxillary disjunction,Septal, vomerine, and lateral nasal osteotomiesDown fractureMobilization of the maxillaApplication of stent in one group and the locating guide in the other group.Maxillary fixationOcclusal evaluationWound debridement and closure
Active Comparator: (Control group) will be treated with Intermediate wafer.; After le fort 1 osteotomy, Intermediate wafer will be used with intermaxillary fixation.	Procedure: Orthognathic surgery (lefort1); All patients will be treated under general anesthesia.; The surgical field will be scrubbed with povidone-iodine surgical scrub solution, followed by draping of the patient with sterile towels exposing only the area of surgery.; The surgical procedure of Le Fort I osteotomy will be performed which can be summarized as follows:External reference markingIncision and subperiosteal dissectionMaxillary osteotomyPterygomaxillary disjunction,Septal, vomerine, and lateral nasal osteotomiesDown fractureMobilization of the maxillaApplication of stent in one group and the locating guide in the other group.Maxillary fixationOcclusal evaluationWound debridement and closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic evaluation of accuracy by superimposition	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.	2 weeks
The surgery duration	The time taken between performing the Le fort 1 osteotomy till completion of plate fixation will be measured.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain	Will be assessed through a 10-point Visual Analogue Scale (VAS)	after one week, two weeks

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: orthognathic; virtual planning
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Dentofacial Deformities
• Other Study ID Numbers: orthognathicalexu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No