NCT07724743

Brief Summary

This retrospective cohort study aims to compare the effects of Mini Wing and Box genioplasty performed in conjunction with bimaxillary orthognathic surgery on upper airway area and soft tissue profile in adult patients with skeletal Class II dentofacial deformity. Preoperative and postoperative radiographic measurements will be evaluated to determine changes in upper airway area, mentolabial angle, and submental angle. The study also aims to assess whether either genioplasty technique provides superior postoperative functional and esthetic outcomes.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 21, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

7.4 years

First QC Date

July 21, 2026

Last Update Submit

July 21, 2026

Conditions

Class II MalocclusionDentofacial DeformitiesRetrognathia

Keywords

Mini Wing GenioplastyBox GenioplastyOrthognathic SurgeryBimaxillary SurgeryGenioplasty

Outcome Measures

Primary Outcomes (1)

  • Change in Upper Airway Area

    Change in upper airway area measured on cone-beam computed tomography (CBCT) images obtained before surgery and 6 months after surgery.

    Preoperative and 6 months after surgery

Secondary Outcomes (2)

  • Change in Mentolabial Angle

    Preoperative and 6 months after surgery

  • Change in Submental Angle

    Preoperative and 6 months after surgery

Study Arms (2)

Mini Wing Genioplasty

Patients with skeletal Class II dentofacial deformity who underwent bimaxillary orthognathic surgery combined with Mini Wing genioplasty.

Procedure: Mini Wing Genioplasty

Box Genioplasty

Patients with skeletal Class II dentofacial deformity who underwent bimaxillary orthognathic surgery combined with Box genioplasty.

Procedure: Box Genioplasty

Interventions

Mini Wing GenioplastyPROCEDURE

Mini Wing genioplasty performed in conjunction with bimaxillary orthognathic surgery for correction of skeletal Class II dentofacial deformity.

Mini Wing Genioplasty
Box GenioplastyPROCEDURE

Box genioplasty performed in conjunction with bimaxillary orthognathic surgery for correction of skeletal Class II dentofacial deformity.

Box Genioplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with skeletal Class II dentofacial deformity who underwent bimaxillary orthognathic surgery combined with Mini Wing or Box genioplasty at Istanbul Medipol University between 2019 and 2025.

You may qualify if:

  • Adults aged 18 years or older.
  • Diagnosis of skeletal Class II dentofacial deformity.
  • Underwent bimaxillary orthognathic surgery combined with either Mini Wing or Box genioplasty.
  • Available preoperative and postoperative CBCT images obtained 6 months after surgery.
  • Complete clinical and radiographic records.

You may not qualify if:

  • Previous orthognathic or genioplasty surgery.
  • Craniofacial syndromes or congenital craniofacial anomalies.
  • History of facial trauma affecting craniofacial morphology.
  • Incomplete clinical records or missing CBCT data.
  • Poor-quality CBCT images unsuitable for analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University Hospital

Bağcılar, Istanbul, 34214, Turkey (Türkiye)

Location

MeSH Terms

Conditions

OverbiteDentofacial DeformitiesRetrognathia

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class IIMalocclusionTooth DiseasesStomatognathic DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesJaw AbnormalitiesJaw DiseasesMandibular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, Department of Oral and Maxillofacial Surgery

Study Record Dates

First Submitted

July 21, 2026

First Posted

July 24, 2026

Study Start

March 1, 2019

Primary Completion

July 20, 2026

Study Completion

July 20, 2026

Last Updated

July 24, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the study is retrospective and contains confidential patient information. Data sharing is restricted to protect participant privacy and is subject to institutional and ethical regulations.

Locations

TU(1)