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

Completed

• Conditions: Malocclusion

• Registration Number: NCT06235138
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief 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, \*\*).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-15
• Primary Completion: 2022-08-15
• Study Completion: 2023-08-15
• Status Verified: 2023-12
• Study First Submitted: 2024-01-11
• Study First Submitted QC: 2024-01-23
• Last Update Submitted: 2024-01-23
• Study First Posted: 2024-01-31
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (2)

CHU de Nice; 🇫🇷 Nice, Alpes Maritimes, France

CHU NICE; 🇫🇷 Nice, Alpes Maritimes, France