Le Fort; INCT06629935
Impact of Different Instrument Modifications on Lateral Nasal Wall Osteotomy and Pterygomaxillary Separation in Le Fort I Surgery
A study testing orthognathic surgery in people with Le Fort; I and Blood Loss, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effect of different instrument modifications on the customized osteotomy of the lateral nasal wall in Le Fort I surgery, focusing on the level of lateral nasal wall fractures and the separation pattern of the pterygomaxillary junction. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Le Fort; I, Blood Loss
- What is being tested?
- orthognathic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 12 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients requiring Le Fort I or bimaxillary surgery
- Patients who have not previously undergone Le Fort I or bimaxillary surgery (revision)
- Patients without cleft lip or palate
- Patients with no history of midface fractures or craniofacial trauma
Who cannot join
- Patients with cleft lip and/or palate requiring orthognathic surgery
- Patients with a history of trauma needing orthognathic surgery for malocclusion correction
- Patients who have previously undergone orthognathic surgery and require revision surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf Universty
Istanbul, Fatih, 34093
About this study
Official title: Assessment of How Different Instrument Modifications in Le Fort I Surgery Influence the Osteotomy of the Lateral Nasal Wall, With a Focus on the Level of Fractures and the Separation Pattern of the Pterygomaxillary Junction
The aim of this study is to investigate the effect of different instrument modifications on the customized osteotomy of the lateral nasal wall in Le Fort I surgery, focusing on the level of lateral nasal wall fractures and the separation pattern of the pterygomaxillary junction.
The primary hypothesis is blade osteotome is useful and facilitate the fracture line in ideal level both for lateral nasal wall and the pterygomaxillary junction.
Read the detailed description
While there are numerous studies in the literature evaluating various parameters related to maxillary down-fracture in Le Fort I osteotomy, studies specifically focused on lateral nasal osteotomy are very rare. There is no study in the literature has addressed customized lateral nasal osteotomy using different instruments. In our study, the lateral nasal wall osteotomy will be performed 2 mm shorter than the measured descending palatine ater distance in the axial computer tomography plane. One group (n=23) will use the routinely employed Nievert osteotome (single guided osteotome), while the other group (n=23) will use a blade osteotome (no guided tip). This study aims to evaluate parameters such as the fracture pattern of the lateral nasal walls and the separation pattern of the pterygomaxillary junction by using different instrument modifications for lateral nasal wall osteotomy.
- Conditions
- Le Fort; I, Blood Loss
- Being tested
- orthognathic surgery
- Keywords
- orthognthic surgery, le fort I, lateral nasal wall, pterygomaxillary junction
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthognathic surgeryProcedure or surgery
Le Fort I surgery
| Study group | Role | What they receive |
|---|---|---|
| Nievert osteotomy group | Experimental | lateral nasal wall osteotomy has been performed with single guided Nievert osteotome. Receives: Procedure: orthognathic surgery |
| Blade osteotomy group | Active comparator | lateral nasal wall osteotomy has been performed with blade osteotome. Receives: Procedure: orthognathic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
lateral nasal wall fracture type
Class 1: Fracture at the osteotomy line Class 2: Fracture 2-4 mm above the osteotomy line Class 3: Fracture more than 4 mm above the osteotomy line
Measured: 6 months
Secondary outcomes (1)
pterygomaxillary junction fracture type
Class 1: Separation at the tuberosity of the maxilla Class 2: Separation at the pterygomaxillary junction Class 3: Separation of the pterygoids plates
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 May 2024
- Primary completion12 Aug 2024
- Study completion12 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Le Fort; IStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629935
- Sponsor's protocol ID
- 2024-KAEK-03
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akkoyun EF, Pergel T, Dolanmaz D. Is Osteotome Type Associated With Lateral Nasal Wall Separation and Nasal Mucosal Integrity in Le Fort I Osteotomy? J Oral Maxillofac Surg. 2026 Jun;84(6):850-858. doi: 10.1016/j.joms.2026.01.071. Epub 2026 Feb 5.
PubMed 41722612
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of How Different Instrument Modifications in Le Fort I Surgery Influence the Osteotomy of the Lateral Nasal Wall, With a Focus on the Level of Fractures and the Separation Pattern of the Pterygomaxillary Junction
- ClinicalTrials.gov ID
- NCT06629935
- Acronym / sponsor ID
- 2024-KAEK-03
- Conditions
- Le Fort; I, Blood Loss
- Keywords
- orthognthic surgery, le fort I, lateral nasal wall, pterygomaxillary junction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 8 Oct 2024 (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.
The aim of this study is to investigate the effect of different instrument modifications on the customized osteotomy of the lateral nasal wall in Le Fort I surgery, focusing on the level of lateral nasal wall fractures and the separation pattern of the pterygomaxillary junction.
The primary hypothesis is blade osteotome is useful and facilitate the fracture line in ideal level both for lateral nasal wall and the pterygomaxillary junction.
Detailed description
While there are numerous studies in the literature evaluating various parameters related to maxillary down-fracture in Le Fort I osteotomy, studies specifically focused on lateral nasal osteotomy are very rare. There is no study in the literature has addressed customized lateral nasal osteotomy using different instruments. In our study, the lateral nasal wall osteotomy will be performed 2 mm shorter than the measured descending palatine ater distance in the axial computer tomography plane. One group (n=23) will use the routinely employed Nievert osteotome (single guided osteotome), while the other group (n=23) will use a blade osteotome (no guided tip). This study aims to evaluate parameters such as the fracture pattern of the lateral nasal walls and the separation pattern of the pterygomaxillary junction by using different instrument modifications for lateral nasal wall osteotomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nievert osteotomy group | Experimental | Procedure: orthognathic surgerylateral nasal wall osteotomy has been performed with single guided Nievert osteotome. |
| Blade osteotomy group | Active comparator | Procedure: orthognathic surgerylateral nasal wall osteotomy has been performed with blade osteotome. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients requiring Le Fort I or bimaxillary surgery
- Patients who have not previously undergone Le Fort I or bimaxillary surgery (revision)
- Patients without cleft lip or palate
- Patients with no history of midface fractures or craniofacial trauma
Key exclusion criteria (3 listed)
- Patients with cleft lip and/or palate requiring orthognathic surgery
- Patients with a history of trauma needing orthognathic surgery for malocclusion correction
- Patients who have previously undergone orthognathic surgery and require revision surgery
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 |
|---|---|---|
| orthognathic surgeryLe Fort I surgery | Procedure or surgery | Blade osteotomy group, Nievert osteotomy group |
Primary outcome
lateral nasal wall fracture type
Time frame: 6 months
Class 1: Fracture at the osteotomy line Class 2: Fracture 2-4 mm above the osteotomy line Class 3: Fracture more than 4 mm above the osteotomy line
1 secondary outcome
pterygomaxillary junction fracture type
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Derived from this study: PubMed 41722612Akkoyun EF, Pergel T, Dolanmaz D. Is Osteotome Type Associated With Lateral Nasal Wall Separation and Nasal Mucosal Integrity in Le Fort I Osteotomy? J Oral Maxillofac Surg. 2026 Jun;84(6):850-858. doi: 10.1016/j.joms.2026.01.071. Epub 2026 Feb 5.
- Individual participant dataSharing planned: No
Related trials for Le Fort; I
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Not yet recruitingObservational study
Finite Element Modelling of Le Fort I Osteotomy Fixation : PSI vs Miniplates
Malocclusion
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?
A study testing orthognathic surgery in people with Le Fort; I and Blood Loss, 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 8 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
lateral nasal wall fracture type (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06629935, which also lists 1 linked publication.
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 8 Oct 2024.