Jawline Improvement Using Patient-specific Angle Implants With Virtual Planning in Orthognathic Surgery

Malocclusion Clinical Trial

Official title:

Jawline Improvement Using Patient-specific Angle Implants With Virtual Planning in Orthognathic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06235138
• Other study ID #: 23IUFC01
• Status: Completed
• Start date: May 15, 2017
• Est. completion date: August 15, 2023

Study information

• Verified date: December 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background: Jawline improvement is nowadays a strong patients' demand. Among patients undergoing orthognathic surgery, it remains sometimes a challenge to manage angle definition due to the classic mandibular osteotomy trait which mostly allows sagittal mandibular movements but can't modify the ramus height. A few types of osteotomies can be used to improve jawline's shape while correcting malocclusion, but they remain technically difficult and often imply the necessity for bone grafting and/or the use of a specific saw and screwdriver. The advent of computer-assisted surgical planning and computer-aided design/ computer-aided manufacturing (CAD-CAM) techniques for patient-specific implant (PSI) fabrication has enabled new methods for managing the jawline in orthognathic surgery. The aim of this study was to assess jawline improvement with patient-specific angle implants in patients undergoing orthognathic surgery with standard osteotomies.Methods: A virtual simulation of a Le Fort I osteotomy (if needed), a sagittal split ramus osteotomy with patient-specific titanium angle implants, and a genioplasty (if needed) was conducted on a preoperative three-dimensional (3D) model of each patient's skull using ProPlan CMF software (Materialise, Leuven, Belgium). Computer-assisted osteotomy saw-and-drill guides and patient-specific implants (PSIs, titanium plates and angle implants) were produced and used during the surgery. The investigators chose to focus on jawline improvement by comparing the preoperative and the post-operative 3D-photographs using the VECTRA H2 3D imagine system (Canfield Scientific, **).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 15, 2023
• Est. primary completion date: August 15, 2022
• Gender: All
• Age group: 18 Years to 43 Years

Eligibility

• Inclusion Criteria: patients undergoing orthognathic surgery and jawline correction with patient-specific angle implants at Head and Neck Institute, Nice, France

• Exclusion Criteria: None

Related Conditions & MeSH terms

• Malocclusion

Locations

Country	Name	City	State
France	CHU de Nice	Nice	Alpes Maritimes
France	CHU NICE	Nice	Alpes Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome of interest was the postoperative aspect and position of the gonial angle	The primary outcome of interest was the postoperative aspect and position of the gonial angle, assessed by 3D-stereophotogrametry	postoperative week 4
Primary	Secondary outcome of interest is patients satisfaction	Scale title = échelle de Likert. Maximum score 5 (= not satisfied) / minimum score 1 (= total satisfaction)	From post operative week 1 to one year follow-up
Primary	Secondary outcome of interest is number and type of complications	Secondary outcome of interest is number and type of complications	From post operative week 1 to one year follow-up