Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06235138
Status:
COMPLETED
Last Update Posted:
2024-01-31
First Post:
2024-01-11
Brief Title:
Jawline Improvement Using Patient-specific Angle Implants With Virtual Planning in Orthognathic Surgery
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
Jawline Improvement Using Patient-specific Angle Implants With Virtual Planning in Orthognathic Surgery
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 cant modify the ramus height A few types of osteotomies can be used to improve jawlines shape while correcting malocclusion but they remain technically difficult and often imply the necessity for bone grafting andor 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 osteotomiesMethods 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 patients 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None