Class II MalocclusionMWBOXNCT07724743
Comparative Evaluation of Functional and Aesthetic Outcomes of Box and Mini-Wing Genioplasty Techniques
An observational study of Class II Malocclusion and Dentofacial Deformities, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Class II Malocclusion, Dentofacial Deformities, Retrognathia
- What is being tested?
- Mini Wing Genioplasty and Box Genioplasty
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 20 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Hospital
Bağcılar, Istanbul, 34214
About this study
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.
Read the 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.
- Conditions
- Class II Malocclusion, Dentofacial Deformities, Retrognathia
- Being tested
- Mini Wing Genioplasty, Box Genioplasty
- Keywords
- Mini Wing Genioplasty, Box Genioplasty, Orthognathic Surgery, Bimaxillary Surgery, Genioplasty
- Medical subject headings
- Overbite, Dentofacial Deformities, Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini Wing GenioplastyProcedure or surgery
Mini Wing genioplasty performed in conjunction with bimaxillary orthognathic surgery for correction of skeletal Class II dentofacial deformity.
Box GenioplastyProcedure or surgery
Box genioplasty performed in conjunction with bimaxillary orthognathic surgery for correction of skeletal Class II dentofacial deformity.
| Study group | Role | What they receive |
|---|---|---|
| Mini Wing Genioplasty | Patients with skeletal Class II dentofacial deformity who underwent bimaxillary orthognathic surgery combined with Mini Wing genioplasty. Receives: Procedure: Mini Wing Genioplasty | |
| Box Genioplasty | Patients with skeletal Class II dentofacial deformity who underwent bimaxillary orthognathic surgery combined with Box genioplasty. Receives: Procedure: Box Genioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative and 6 months after surgery
Secondary outcomes (2)
Change in Mentolabial Angle
Change in the mentolabial angle measured on CBCT images before surgery and 6 months after surgery.
Measured: Preoperative and 6 months after surgery
Change in Submental Angle
Change in the submental angle measured on CBCT images before surgery and 6 months after surgery.
Measured: Preoperative and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Mar 2019
- Primary completion20 Jul 2026
- Study completion20 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Gaye Akgök, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724743
- Sponsor's protocol ID
- MEDIPOL-GENIO-2026-001
- Other IDs
- E-10840098-50.04-1779
- Acronym
- MWBOX
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Functional and Aesthetic Outcomes of Box and Mini-Wing Genioplasty Techniques
- ClinicalTrials.gov ID
- NCT07724743
- Acronym / sponsor ID
- MWBOX / MEDIPOL-GENIO-2026-001
- Conditions
- Class II Malocclusion, Dentofacial Deformities, Retrognathia
- Keywords
- Mini Wing Genioplasty, Box Genioplasty, Orthognathic Surgery, Bimaxillary Surgery, Genioplasty
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 20 Jul 2026 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini Wing Genioplasty | – | Procedure: Mini Wing GenioplastyPatients with skeletal Class II dentofacial deformity who underwent bimaxillary orthognathic surgery combined with Mini Wing genioplasty. |
| Box Genioplasty | – | Procedure: Box GenioplastyPatients with skeletal Class II dentofacial deformity who underwent bimaxillary orthognathic surgery combined with Box genioplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini Wing GenioplastyMini Wing genioplasty performed in conjunction with bimaxillary orthognathic surgery for correction of skeletal Class II dentofacial deformity. | Procedure or surgery | Mini Wing Genioplasty |
| Box GenioplastyBox genioplasty performed in conjunction with bimaxillary orthognathic surgery for correction of skeletal Class II dentofacial deformity. | Procedure or surgery | Box Genioplasty |
Primary outcome
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.
2 secondary outcomes
Change in Mentolabial Angle
Time frame: Preoperative and 6 months after surgery
Change in Submental Angle
Time frame: Preoperative and 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Class II Malocclusion and Dentofacial Deformities, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Upper Airway Area (time frame: Preoperative and 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.