- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07724743
Comparative Evaluation of Functional and Aesthetic Outcomes of Box and Mini-Wing Genioplasty Techniques (MWBOX)
Study Overview
Status
Intervention / Treatment
Detailed Description
Skeletal Class II dentofacial deformity is commonly treated with bimaxillary orthognathic surgery combined with genioplasty to improve facial harmony and functional outcomes. Among the available genioplasty techniques, Mini Wing and Box genioplasty differ in their osteotomy design and the direction of chin advancement, which may influence postoperative soft tissue profile and upper airway morphology.
This retrospective cohort study includes adult patients who underwent bimaxillary orthognathic surgery with either Mini Wing or Box genioplasty at Istanbul Medipol University between 2019 and 2025. Patients meeting the predefined inclusion and exclusion criteria will be identified through hospital records. Preoperative and postoperative cone-beam computed tomography (CBCT) images will be analyzed to evaluate changes in upper airway area, mentolabial angle, and submental angle.
Demographic characteristics and baseline measurements will be compared between groups to ensure similarity before surgery. Postoperative changes within each group and differences between the two surgical techniques will be statistically analyzed. The findings are expected to provide evidence regarding the effects of Mini Wing and Box genioplasty on upper airway dimensions and soft tissue profile, thereby supporting surgical planning and technique selection in patients with skeletal Class II deformity.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Istanbul
-
Bağcılar, Istanbul, Turkey (Türkiye), 34214
- Istanbul Medipol University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Mini Wing Genioplasty
Patients with skeletal Class II dentofacial deformity who underwent bimaxillary orthognathic surgery combined with Mini Wing genioplasty.
|
Mini Wing genioplasty performed in conjunction with bimaxillary orthognathic surgery for correction of skeletal Class II dentofacial deformity.
|
|
Box Genioplasty
Patients with skeletal Class II dentofacial deformity who underwent bimaxillary orthognathic surgery combined with Box genioplasty.
|
Box genioplasty performed in conjunction with bimaxillary orthognathic surgery for correction of skeletal Class II dentofacial deformity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Upper Airway Area
Time Frame: Preoperative and 6 months after surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Mentolabial Angle
Time Frame: Preoperative and 6 months after surgery
|
Change in the mentolabial angle measured on CBCT images before surgery and 6 months after surgery.
|
Preoperative and 6 months after surgery
|
|
Change in Submental Angle
Time Frame: Preoperative and 6 months after surgery
|
Change in the submental angle measured on CBCT images before surgery and 6 months after surgery.
|
Preoperative and 6 months after surgery
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Jaw Diseases
- Tooth Diseases
- Jaw Abnormalities
- Maxillofacial Abnormalities
- Craniofacial Abnormalities
- Musculoskeletal Abnormalities
- Mandibular Diseases
- Stomatognathic System Abnormalities
- Congenital Abnormalities
- Malocclusion, Angle Class II
- Malocclusion
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Retrognathia
- Overbite
- Dentofacial Deformities
Other Study ID Numbers
- MEDIPOL-GENIO-2026-001
- E-10840098-50.04-1779 (Other Identifier: Istanbul Medipol University Non-Interventional Clinical Research Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Retrognathia
-
Batman UniversityCompletedMandibular RetrognathiaTurkey
-
University of PaviaCompletedEvaluation of Masticatory Muscle Activity in Pediatric Patients Undergoing Rapid Maxillary ExpansionMaxillar HypoplasiaItaly
-
Cairo UniversityRecruitingPosterior Crossbite | Maxilla; HypoplasiaEgypt
-
University of PaviaEnrolling by invitationMaxillary DeficiencyItaly
-
Cairo UniversityUnknown
-
Al-Azhar UniversityRecruitingMaxillary Deficiency | Maxillary RetrusionEgypt
-
Konya Necmettin Erbakan ÜniversitesiCompleted
-
Universitat Internacional de CatalunyaUniversidad de los Andes, ChileNot yet recruitingOrthognathic Surgery | Prognathism | Neurosensory Disorder | Retrognathism
-
TC Erciyes UniversityCompletedMaxillary RetrusionTurkey
-
Gökçenur Gökçe KaraEge University; Izmir Katip Celebi UniversityCompletedSleep Apnea Syndromes in Children | Functional Orthodontic Treatment | Mandibular Retrognathia | Upper AirwayTurkey
Clinical Trials on Mini Wing Genioplasty
-
St. Joseph Mercy Oakland HospitalCompletedInguinal HerniaUnited States
-
Cairo UniversityUnknownMacrogenia | Microgenia | MiniplateEgypt
-
Cairo UniversityUnknownChin MicrogeniaEgypt
-
Faculty of Dental Medicine for GirlsCompleted
-
Roseman University of Health SciencesActive, not recruitingPartial-edentulism | Missing TeethUnited States
-
Cairo UniversityCompleted
-
Cairo UniversityNot yet recruitingAccuracy of 3D Printed Titanium Plates Versus 3D Milled Titanium Plates in Genioplasty Orthognathic Surgery | Patient Specific Genioplasty | Accuracy of 3D Printed Titanium Plates Versus 3D Milled Titanium Plates in Genioplasty
-
Cairo UniversityUnknown
-
Cairo UniversityOctober University for Modern Sciences and ArtsCompleted
-
San Diego State UniversityRecruiting