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

Dentofacial Deformities Clinical Trial

— orthognathic  

Official title:

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 Trial Details — Status: Completed

Administrative data

• NCT number: NCT06132906
• Other study ID #: orthognathicalexu
• Status: Completed
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: November 1, 2023

Study information

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

Clinical Trial 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)

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.

Recruitment information / eligibility

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

Eligibility

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.

Related Conditions & MeSH terms

• Dentofacial Deformities
• Le Fort; I

Intervention

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 marking Incision and subperiosteal dissection Maxillary osteotomy Pterygomaxillary disjunction, Septal, vomerine, and lateral nasal osteotomies Down fracture Mobilization of the maxilla Application of stent in one group and the locating guide in the other group. Maxillary fixation Occlusal evaluation Wound debridement and closure

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 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
Primary	The surgery duration	The time taken between performing the Le fort 1 osteotomy till completion of plate fixation will be measured.	1 week
Secondary	Postoperative Pain	Will be assessed through a 10-point Visual Analogue Scale (VAS)	after one week, two weeks