Orthognathic Surgical ProceduresNCT07788976
Mandibular Medial Osteotomy Modifications and Postoperative Stability
A study testing sagittal split osteotomy, Hunsuck Modification of Medial Mandibular Osteotomy and Posnick Modification Group in people with Orthognathic Surgical Procedures, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the effects of the Hunsuck and Posnick modifications of medial mandibular osteotomy on postoperative skeletal stability and relapse in patients undergoing orthognathic surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthognathic Surgical Procedures
- What is being tested?
- sagittal split osteotomy, Hunsuck Modification of Medial Mandibular Osteotomy and Posnick Modification Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 25 Apr 2027
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with an indication for orthognathic surgery who are planned to undergo bimaxillary orthognathic surgery.
- Patients who have undergone preoperative orthodontic treatment.
- Patients aged 18-65 years.
Who cannot join
- Patients who develop an unfavorable split (bad split) during surgery.
- Patients with cleft lip and palate, craniofacial syndromes, or a history of facial trauma.
- Patients who have previously undergone orthognathic surgery and require revision surgery.
- Patients whose computed tomography (CT) records are inadequate for the required measurements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem vakif university
Istanbul, Fatih, 34093
Emine Fulya Akkoyun, Dr., +905372676871, efulyaakkoyun@hotmail.com
About this study
Official title: The Effect of Mandibular Medial Osteotomy Modifications on Postoperative Stability Following Orthognathic Surgery
This study aims to compare the effects of the Hunsuck and Posnick modifications of medial mandibular osteotomy on postoperative skeletal stability and relapse in patients undergoing orthognathic surgery. The study will evaluate whether the choice of medial osteotomy technique influences postoperative mandibular relapse.
Read the detailed description
This study aims to evaluate and compare the effects of two different medial mandibular osteotomy modifications, namely the Hunsuck and Posnick techniques, on postoperative skeletal stability and relapse in patients undergoing orthognathic surgery.
Patients who meet the study eligibility criteria and are scheduled to undergo bilateral sagittal split ramus osteotomy (BSSO) as part of orthognathic surgery will be included. Depending on the medial mandibular osteotomy technique used, patients will be evaluated in two groups: those undergoing the Hunsuck modification and those undergoing the Posnick modification.
Preoperative and postoperative radiographic records will be evaluated to assess skeletal changes associated with each osteotomy technique. Postoperative skeletal stability will be assessed by comparing relevant mandibular and skeletal reference points and angular measurements between the preoperative, immediate postoperative, and follow-up imaging records. The amount and direction of postoperative skeletal relapse will be determined based on changes occurring during the follow-up period.
The primary objective is to determine whether the Hunsuck and Posnick modifications differ in terms of postoperative skeletal stability and relapse following orthognathic surgery. Secondary evaluations may include assessment of the magnitude and direction of mandibular positional changes and comparison of the radiographic outcomes between the two techniques.
The findings of this study may provide clinically relevant information regarding the influence of medial mandibular osteotomy design on postoperative skeletal stability and may help guide the selection of an appropriate osteotomy technique in orthognathic surgery.
- Conditions
- Orthognathic Surgical Procedures
- Being tested
- sagittal split osteotomy, Hunsuck Modification of Medial Mandibular Osteotomy, Posnick Modification Group
- Keywords
- orthognathic surgery, relapse
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sagittal split osteotomyProcedure or surgery
Bilateral sagittal split ramus osteotomy will be performed as part of orthognathic surgery to correct the planned mandibular skeletal deformity. The mandibular ramus and body will be divided using the assigned medial osteotomy modification (Hunsuck or Posnick), followed by sagittal splitting of the mandible. The distal mandibular segment will then be repositioned according to the preoperative surgical plan and stabilized using appropriate osteosynthesis. Postoperative skeletal stability and mandibular relapse will be evaluated during the follow-up period.
Hunsuck Modification of Medial Mandibular OsteotomyProcedure or surgery
The Hunsuck modification of the medial mandibular osteotomy will be performed during bilateral sagittal split ramus osteotomy (BSSO). The medial horizontal osteotomy will be initiated at the lingula and extended posteriorly for a short distance, according to the Hunsuck modification. The remaining steps of the BSSO will be performed using the standard surgical technique. Postoperative skeletal stability and relapse will be assessed using preoperative, immediate postoperative, and follow-up radiographic evaluations
Posnick Modification GroupProcedure or surgery
The Posnick modification of the medial mandibular osteotomy will be performed during bilateral sagittal split ramus osteotomy (BSSO). The medial horizontal osteotomy will be performed according to the Posnick modification, with the osteotomy design extending posteriorly along the medial aspect of the mandibular ramus as described for this technique. The remaining steps of the BSSO will be performed using the standard surgical technique. Postoperative skeletal stability and relapse will be assessed using preoperative, immediate postoperative, and follow-up radiographic evaluations.
| Study group | Role | What they receive |
|---|---|---|
| Hunsuck Modification Group | Experimental | Patients undergoing orthognathic surgery with bilateral sagittal split ramus osteotomy (BSSO) will undergo medial mandibular osteotomy using the Hunsuck modification. The osteotomy will be performed according to the Hunsuck technique, with the medial horizontal osteotomy terminating at the level of the lingula and extending posteriorly to facilitate the sagittal split. Postoperative skeletal stability and relapse will be evaluated during the follow-up period. Receives: Procedure: sagittal split osteotomy; Procedure: Hunsuck Modification of Medial Mandibular Osteotomy |
| Posnick Modification Group | Active comparator | Patients undergoing orthognathic surgery with bilateral sagittal split ramus osteotomy (BSSO) will undergo medial mandibular osteotomy using the Posnick modification. The osteotomy will be performed according to the Posnick technique, with the modified medial osteotomy design extending posteriorly in accordance with the technique. Postoperative skeletal stability and relapse will be evaluated during the follow-up period. Receives: Procedure: sagittal split osteotomy; Procedure: Posnick Modification Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Skeletal Relapse
The primary outcome will be the amount and percentage of skeletal relapse between 1 month and 12 months after orthognathic surgery (T3-T1), assessed using three-dimensional cephalometric and skeletal measurements.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Jan 2026
- Primary completion28 Dec 2026 (estimated)
- Study completion25 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthognathic Surgical ProceduresStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788976
- Sponsor's protocol ID
- E.224971
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandibular Medial Osteotomy Modifications on Postoperative Stability Following Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT07788976
- Acronym / sponsor ID
- E.224971
- Conditions
- Orthognathic Surgical Procedures
- Keywords
- orthognathic surgery, relapse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 25 Apr 2027 (estimated)
- First posted
- 27 Aug 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 study aims to compare the effects of the Hunsuck and Posnick modifications of medial mandibular osteotomy on postoperative skeletal stability and relapse in patients undergoing orthognathic surgery. The study will evaluate whether the choice of medial osteotomy technique influences postoperative mandibular relapse.
Detailed description
This study aims to evaluate and compare the effects of two different medial mandibular osteotomy modifications, namely the Hunsuck and Posnick techniques, on postoperative skeletal stability and relapse in patients undergoing orthognathic surgery.
Patients who meet the study eligibility criteria and are scheduled to undergo bilateral sagittal split ramus osteotomy (BSSO) as part of orthognathic surgery will be included. Depending on the medial mandibular osteotomy technique used, patients will be evaluated in two groups: those undergoing the Hunsuck modification and those undergoing the Posnick modification.
Preoperative and postoperative radiographic records will be evaluated to assess skeletal changes associated with each osteotomy technique. Postoperative skeletal stability will be assessed by comparing relevant mandibular and skeletal reference points and angular measurements between the preoperative, immediate postoperative, and follow-up imaging records. The amount and direction of postoperative skeletal relapse will be determined based on changes occurring during the follow-up period.
The primary objective is to determine whether the Hunsuck and Posnick modifications differ in terms of postoperative skeletal stability and relapse following orthognathic surgery. Secondary evaluations may include assessment of the magnitude and direction of mandibular positional changes and comparison of the radiographic outcomes between the two techniques.
The findings of this study may provide clinically relevant information regarding the influence of medial mandibular osteotomy design on postoperative skeletal stability and may help guide the selection of an appropriate osteotomy technique in orthognathic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hunsuck Modification Group | Experimental | Procedure: sagittal split osteotomy, Procedure: Hunsuck Modification of Medial Mandibular OsteotomyPatients undergoing orthognathic surgery with bilateral sagittal split ramus osteotomy (BSSO) will undergo medial mandibular osteotomy using the Hunsuck modification. The osteotomy will be performed according to the Hunsuck technique, with the medial horizontal osteotomy terminating at the level of the lingula and extending posteriorly to facilitate the sagittal split. Postoperative skeletal stability and relapse will be evaluated during the follow-up period. |
| Posnick Modification Group | Active comparator | Procedure: sagittal split osteotomy, Procedure: Posnick Modification GroupPatients undergoing orthognathic surgery with bilateral sagittal split ramus osteotomy (BSSO) will undergo medial mandibular osteotomy using the Posnick modification. The osteotomy will be performed according to the Posnick technique, with the modified medial osteotomy design extending posteriorly in accordance with the technique. Postoperative skeletal stability and relapse will be evaluated during the follow-up period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with an indication for orthognathic surgery who are planned to undergo bimaxillary orthognathic surgery.
- Patients who have undergone preoperative orthodontic treatment.
- Patients aged 18-65 years.
Key exclusion criteria (4 listed)
- Patients who develop an unfavorable split (bad split) during surgery.
- Patients with cleft lip and palate, craniofacial syndromes, or a history of facial trauma.
- Patients who have previously undergone orthognathic surgery and require revision surgery.
- Patients whose computed tomography (CT) records are inadequate for the required measurements.
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 |
|---|---|---|
| sagittal split osteotomyBilateral sagittal split ramus osteotomy will be performed as part of orthognathic surgery to correct the planned mandibular skeletal deformity. The mandibular ramus and body will be divided using the assigned medial osteotomy modification (Hunsuck or Posnick), followed by sagittal splitting of the mandible. The distal mandibular segment will then be repositioned according to the preoperative surgical plan and stabilized using appropriate osteosynthesis. Postoperative skeletal stability and mandibular relapse will be evaluated during the follow-up period. | Procedure or surgery | Hunsuck Modification Group, Posnick Modification Group |
| Hunsuck Modification of Medial Mandibular OsteotomyThe Hunsuck modification of the medial mandibular osteotomy will be performed during bilateral sagittal split ramus osteotomy (BSSO). The medial horizontal osteotomy will be initiated at the lingula and extended posteriorly for a short distance, according to the Hunsuck modification. The remaining steps of the BSSO will be performed using the standard surgical technique. Postoperative skeletal stability and relapse will be assessed using preoperative, immediate postoperative, and follow-up radiographic evaluations | Procedure or surgery | Hunsuck Modification Group |
| Posnick Modification GroupThe Posnick modification of the medial mandibular osteotomy will be performed during bilateral sagittal split ramus osteotomy (BSSO). The medial horizontal osteotomy will be performed according to the Posnick modification, with the osteotomy design extending posteriorly along the medial aspect of the mandibular ramus as described for this technique. The remaining steps of the BSSO will be performed using the standard surgical technique. Postoperative skeletal stability and relapse will be assessed using preoperative, immediate postoperative, and follow-up radiographic evaluations. | Procedure or surgery | Posnick Modification Group |
Primary outcome
Postoperative Skeletal Relapse
Time frame: 1 year
The primary outcome will be the amount and percentage of skeletal relapse between 1 month and 12 months after orthognathic surgery (T3-T1), assessed using three-dimensional cephalometric and skeletal measurements.
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 27 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sagittal split osteotomy, Hunsuck Modification of Medial Mandibular Osteotomy and Posnick Modification Group in people with Orthognathic Surgical Procedures, run by Bezmialem Vakif University 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 27 Aug 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?
Contact Emine Fulya Akkoyun, Dr. (+905372676871, efulyaakkoyun@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Skeletal Relapse (time frame: 1 year). 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 27 Aug 2026.