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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06235138
Enrollment
20
Registered
2024-01-31
Start date
2017-05-15
Completion date
2023-08-15
Last updated
2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusion

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, \*\*).

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 43 Years

Inclusion 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

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026