Clinical trial NCT06235138: Jawline Improvement Using Patient-specific Angle Implants With Virtual Planning in Orthognathic Surgery
Official title: Jawline Improvement Using Patient-specific Angle Implants With Virtual Planning in Orthognathic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malocclusion
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing orthognathic surgery and jawline correction with patient-specific angle implants at Head and Neck Institute, Nice, France

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, \*\*).


Eligibility criteria: * Inclusion Criteria: patients undergoing orthognathic surgery and jawline correction with patient-specific angle implants at Head and Neck Institute, Nice, France
* Exclusion Criteria: None

Primary outcomes:
measure: The primary outcome of interest was the postoperative aspect and position of the gonial angle
timeFrame: postoperative week 4
measure: Secondary outcome of interest is patients satisfaction
timeFrame: From post operative week 1 to one year follow-up
measure: Secondary outcome of interest is number and type of complications
timeFrame: From post operative week 1 to one year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
state: Alpes Maritimes
city: Nice
country: France
facility: CHU NICE
state: Alpes Maritimes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Olina RIOS
role: PRINCIPAL_INVESTIGATOR
References: