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

NCT06235138 | Completed

• 1 other identifier: 23IUFC01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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, \*\*).

Conditions

Malocclusion

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (2)

CHU de Nice

Nice, Alpes Maritimes, 06000, France

Location

CHU NICE

Nice, Alpes Maritimes, 06000, France

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Olina RIOS

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 31, 2024
• Study Start: May 15, 2017
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2023
• Last Updated: January 31, 2024

Record last verified: 2023-12

Locations

FR (2)