MalocclusionNCT06233188
Effect of Customized Lateral Nasal Wall Osteotomy on the Pterygomaxillary Separation During le Fort I Down-fracture
A study testing orthogantic surgery in people with Malocclusion and Open Bite, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to show the effect of patient specific lateral nasal wall osteotomy to the pterygomaxillary separation during Le Fort I down-fracture. Participants will be divided into two treatment groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malocclusion, Open Bite, Le Fort; I
- What is being tested?
- orthogantic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 May 2023to 5 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- orthognathic surgery to treat malocclusion
- sleep apnea
- jaw asymmetry
Who cannot join
- cleft lip and palate
- previous orthognathic surgery
- rhinoplasty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Patient-specific Depth of the Lateral Nasal Wall Osteotomy Affect the Pterygomaxillary Separation During le Fort I Down-fracture?
The goal of this clinical trial is to show the effect of patient specific lateral nasal wall osteotomy to the pterygomaxillary separation during Le Fort I down-fracture.
Participants will be divided into two treatment groups. In study group, surgery planned according to the patients' indivudial anatomy and in the conventional group, surgery planned according to mean anatomical datas.
Researchers will compare patient specific lateral nasal wall osteotomy to see if it affects the pterygomaxillary junction seperation during le fort I downfracture.
Read the detailed description
The same surgical team performed the osteotomies under general anesthesia with nasotracheal intubation. Hypotensive anesthesia was applied as a standard protocol in all patients. Orthognathic surgery, including Le Fort I and sagittal split ramus osteotomy, was used to correct skeletal deformities.
Bone osteotomy was initiated on the bilateral wall of the maxilla with piezosurgery after a mucosal incision and flap elevation.Lateral nasal osteotomy (LNO) with Nievert Anderson single guarded osteotome, median septum separation with double guarded U-shaped osteotome, and pterygomaxillary junction separation with curved osteotome were performed before the down-fracture. The only difference between the conventional and study groups was the depth of the LNO. In the study group, LNO was performed at a depth of 2 mm less than the measured distance in the axial section. In the conventional osteotomy group, LNO was performed at 30 mm for females and 35 mm for males, as suggested in the literature. A curved osteotome and a mallet were used in each case to separate the pterygomaxillary junction. The down-fracture of the maxilla was performed using a hook and a bone spreader in all patients. When the maxilla was down-fractured, LNW and the pterygomaxillary separation types were assessed intraoperatively. The maxilla was stabilized in its new position by four L-shaped osteosynthesis mini-plates at the zygomaticomaxillary buttress and the aperture piriformis regions.
- Conditions
- Malocclusion, Open Bite, Le Fort; I, Orthognathic Surgery
- Being tested
- orthogantic surgery
- Keywords
- orthognatic surgery, le fort I, arterial bleeding, down fracture, lateral nasal wall, pterygomaxillary junction
- Medical subject headings
- Malocclusion, Open Bite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthogantic surgeryProcedure or surgery
surgery that correcting the maxilla and mandible related with each other
| Study group | Role | What they receive |
|---|---|---|
| study group | Active comparator | In the study group, lateral nasal osteotomy was performed 2 mm less than the measured distance in the axial section Receives: Procedure: orthogantic surgery |
| conventional group | Active comparator | n the conventional osteotomy group, lateral nasal osteotomy was performed 25 mm for female and 30 mm for male patients, as suggested in the literature. Receives: Procedure: orthogantic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
lateral nasal wall separation
The primary outcome variable is lateral nasal wall separation:
Type 1 Separation from the osteotomy line
Type 2 Separation 2-4 mm above the osteotomy line
Type 3 Separation 4 mm or more above the osteotomy line
Measured: 1 year
Secondary outcomes (1)
pterygomaxillary junction separation
The secondary outcome variable is pterygomaxillary separation
Type 1 Separation including the tuber maxilla
Type 2 Separation from the pterygomaxillary junction
Type 3 Separation including the pterygoid plates
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 posted31 Jan 2024
- Study start3 May 2023
- Primary completion15 Oct 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taha Pergel, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233188
- Sponsor's protocol ID
- 2023-E.110541
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Patient-specific Depth of the Lateral Nasal Wall Osteotomy Affect the Pterygomaxillary Separation During le Fort I Down-fracture?
- ClinicalTrials.gov ID
- NCT06233188
- Acronym / sponsor ID
- 2023-E.110541
- Conditions
- Malocclusion, Open Bite, Le Fort; I, Orthognathic Surgery
- Keywords
- orthognatic surgery, le fort I, arterial bleeding, down fracture, lateral nasal wall, pterygomaxillary junction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 31 Jan 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 goal of this clinical trial is to show the effect of patient specific lateral nasal wall osteotomy to the pterygomaxillary separation during Le Fort I down-fracture.
Participants will be divided into two treatment groups. In study group, surgery planned according to the patients' indivudial anatomy and in the conventional group, surgery planned according to mean anatomical datas.
Researchers will compare patient specific lateral nasal wall osteotomy to see if it affects the pterygomaxillary junction seperation during le fort I downfracture.
Detailed description
The same surgical team performed the osteotomies under general anesthesia with nasotracheal intubation. Hypotensive anesthesia was applied as a standard protocol in all patients. Orthognathic surgery, including Le Fort I and sagittal split ramus osteotomy, was used to correct skeletal deformities.
Bone osteotomy was initiated on the bilateral wall of the maxilla with piezosurgery after a mucosal incision and flap elevation.Lateral nasal osteotomy (LNO) with Nievert Anderson single guarded osteotome, median septum separation with double guarded U-shaped osteotome, and pterygomaxillary junction separation with curved osteotome were performed before the down-fracture. The only difference between the conventional and study groups was the depth of the LNO. In the study group, LNO was performed at a depth of 2 mm less than the measured distance in the axial section. In the conventional osteotomy group, LNO was performed at 30 mm for females and 35 mm for males, as suggested in the literature. A curved osteotome and a mallet were used in each case to separate the pterygomaxillary junction. The down-fracture of the maxilla was performed using a hook and a bone spreader in all patients. When the maxilla was down-fractured, LNW and the pterygomaxillary separation types were assessed intraoperatively. The maxilla was stabilized in its new position by four L-shaped osteosynthesis mini-plates at the zygomaticomaxillary buttress and the aperture piriformis regions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Procedure: orthogantic surgeryIn the study group, lateral nasal osteotomy was performed 2 mm less than the measured distance in the axial section |
| conventional group | Active comparator | Procedure: orthogantic surgeryn the conventional osteotomy group, lateral nasal osteotomy was performed 25 mm for female and 30 mm for male patients, as suggested in the literature. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- orthognathic surgery to treat malocclusion
- sleep apnea
- jaw asymmetry
Key exclusion criteria (3 listed)
- cleft lip and palate
- previous orthognathic surgery
- rhinoplasty
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 |
|---|---|---|
| orthogantic surgerysurgery that correcting the maxilla and mandible related with each other | Procedure or surgery | conventional group, study group |
Primary outcome
lateral nasal wall separation
Time frame: 1 year
The primary outcome variable is lateral nasal wall separation: Type 1 Separation from the osteotomy line Type 2 Separation 2-4 mm above the osteotomy line Type 3 Separation 4 mm or more above the osteotomy line
1 secondary outcome
pterygomaxillary junction separation
Time frame: 1 year
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 31 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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?
A study testing orthogantic surgery in people with Malocclusion and Open Bite, 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 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 31 Jan 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 separation (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 31 Jan 2024.