Maxillofacial AbnormalitiesNCT06281197
Does Subspinal Le Fort I Osteotomy Affect the Nasal Airway Volume
A study testing Conventional and Subspinal in people with Maxillofacial Abnormalities, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
After the description of Le Fort fractures, maxillary osteotomies are used to correct dentofacial deformities. The profile changes on nasolabial region resulting from a Le Fort I osteotomy, also that affects nasal airway. The Subspinal Le Fort I osteotomy (SLFIO) describe to prevent undesirable soft tissue changes. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillofacial Abnormalities
- What is being tested?
- Conventional and Subspinal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2021to 15 May 2022
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 18-40, ASA I, without systemic disease, without any drug allergy, and without a history of NSAID use in the week before the operation.
Who cannot join
- ASA II or higher, hepatic or renal dysfunction, neuropathic disease, long-term use of NSAIDs or opioid-derived drugs, a history of allergic reaction to drugs, pain, swelling, inflammation in the head and neck region before the operation, pregnant and breastfeeding with a history of cleft lip and palate and rhinoplasty surgery
Trial locations and contacts
1 site in 1 country.
About this study
After the description of Le Fort fractures, maxillary osteotomies are used to correct dentofacial deformities. The profile changes on nasolabial region resulting from a Le Fort I osteotomy, also that affects nasal airway. The Subspinal Le Fort I osteotomy (SLFIO) describe to prevent undesirable soft tissue changes. In the literature, too many articles have reported the effectiveness of SLFIO in preventing nasal deformation. However, there is no study to evaluate the nasal volume or septum deviation.
Read the detailed description
The purpose of this study was objectively and subjectively to compare the effect of Subspinal Le Fort I Osteotomy and Conventional Le Fort I Osteotomy on nasal airway volume and septum deviation without additional modification such as Ans Reduction, Alar Cinch Suture, V-Y closure.
Surgical procedure; Patients were underwent general anesthesia for bimaxillary orthognathic surgery.
The mucoperiosteal flap was raised to expose the bilateral infraorbital foramina, aperture pyriformis, zygomaticomaxillary, and pterygomaxillary buttress. No dissection was performed between the nasal mucosa and the ANS of the patients in Subspinal Le Fort osteotomy group.A triangular osteotomy line was created between the maxilla and the ANS with a piezosurgery. In Conventional osteotomy group, Le Fort I osteotomy was made using a piezosurgical saw after nasal mucosa elevation. In both groups, osteotomes and pterygoid plaques, nasal septum, and lateral nasal walls were separated.
Follow up:
septum deviation and nasal. airway volume value was measured and recorded in the CBCT images taken before the surgery and at the 6th month after the surgery of each patient.
- Conditions
- Maxillofacial Abnormalities
- Being tested
- Conventional, Subspinal
- Keywords
- Subspinal Le Fort Osteotomy, Nasal airway
- Medical subject headings
- Maxillofacial Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConventionalProcedure or surgery
Also called Group II
Le Fort I osteotomy performed with conventional Le Fort
SubspinalProcedure or surgery
Also called Group I
Osteotomy was performed in the subspinal Le Fort I group that is described by Mommaerts
| Study group | Role | What they receive |
|---|---|---|
| Conventional Group | Experimental | In conventional group, Le Fort I osteotomy was made using a piezosurgical saw after nasal mucosa elevation as usual Le Fort I technique. Receives: Procedure: Conventional |
| Subspinal Group | Active comparator | In Subspinal group, No dissection was performed between the nasal mucosa and the ANS of the patients. Osteotomy was performed in the subspinal Le Fort I group that is described by Mommaerts . A triangular osteotomy line was created between the maxilla and the ANS with a piezosurgery. Receives: Procedure: Subspinal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Septum Deviation
This angle value was measured and recorded in the CBCT images taken before the surgery and at the 6th month after the surgery of each patient. If the angle in the preoperative view is smaller than the angle in the postoperative view, there is a decrease in septum deviation; If it is large, it was accepted that there was an increase in septum deviation.
Measured: up to six months
Evaluation of Nasal Airway
CBCT scans were scanned for anatomical landmarks to adjust the volume analyzed by automatic segmentation in NemoFAB. Dens endpoint of the axis and nasion were found to be the most consistent at the anterior cranial and posterior caudal borders in the mid-sagittal plane The lateral borders were determined as the most lateral part of the nasal cavity. These markers were used to define the cubic area of interest (ROI), which includes the cranial cavity up to the maxillary base. In the sagittal tomography section, the nasal airway volume was measured in cc on the section taken from the midline.
Measured: up to six months
Secondary outcomes (1)
nasal obstruction scale evaluation
The patients filled out the form about NOSE scales in the preoperative evaluation period and the postoperative 6th month, and the sum of the score values given for each question in the questionnaire was calculated and the total scores were recorded
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start15 Jan 2021
- Primary completion15 Aug 2021
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Maxillofacial AbnormalitiesStudies 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
- Model description
- double blind
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selin Celebi, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281197
- Sponsor's protocol ID
- 2021/48
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guenthner TA, Sather AH, Kern EB. The effect of Le Fort I maxillary impaction on nasal airway resistance. Am J Orthod. 1984 Apr;85(4):308-15. doi: 10.1016/0002-9416(84)90188-x.
PubMed 6585148Galbiati G, Maspero C, Giannini L, Guenza GC, Zanoni F, Farronato G. Orthodontic--surgical treatment and respiratory function: rhinomanometric assessment. Minerva Stomatol. 2017 Jun;66(3):91-97. doi: 10.23736/S0026-4970.17.04045-6. Epub 2017 Apr 11.
PubMed 28399616Posnick JC, Agnihotri N. Consequences and management of nasal airway obstruction in the dentofacial deformity patient. Curr Opin Otolaryngol Head Neck Surg. 2010 Aug;18(4):323-31. doi: 10.1097/MOO.0b013e32833b9d6f.
PubMed 20625295Helal HA, Ghanem MAM, Al-Badawy AM, Abdel Haleem MM, Mousa MH. Histological and Anthropometric Changes in the Aging Nose. Aesthet Surg J. 2019 Aug 22;39(9):943-952. doi: 10.1093/asj/sjy245.
PubMed 30247560Schwarz GM, Thrash WJ, Byrd DL, Jacobs JD. Tomographic assessment of nasal septal changes following surgical-orthodontic rapid maxillary expansion. Am J Orthod. 1985 Jan;87(1):39-45. doi: 10.1016/0002-9416(85)90172-1.
PubMed 3881034Kaur S, Rai S, Kaur M. Comparison of reliability of lateral cephalogram and computed tomography for assessment of airway space. Niger J Clin Pract. 2014 Sep-Oct;17(5):629-36. doi: 10.4103/1119-3077.141431.
PubMed 25244276Goncales ES, Duarte MA, Palmieri C Jr, Zakhary GM, Ghali GE. Retrospective analysis of the effects of orthognathic surgery on the pharyngeal airway space. J Oral Maxillofac Surg. 2014 Nov;72(11):2227-40. doi: 10.1016/j.joms.2014.04.006. Epub 2014 Apr 13.
PubMed 24985958Montgomery WM, Vig PS, Staab EV, Matteson SR. Computed tomography: a three-dimensional study of the nasal airway. Am J Orthod. 1979 Oct;76(4):363-75. doi: 10.1016/0002-9416(79)90223-9.
PubMed 291340Kunkel M, Hochban W. The influence of maxillary osteotomy on nasal airway patency and geometry. Mund Kiefer Gesichtschir. 1997 Jul;1(4):194-8. doi: 10.1007/BF03043550.
PubMed 9384792Erbe M, Lehotay M, Gode U, Wigand ME, Neukam FW. Nasal airway changes after Le Fort I--impaction and advancement: anatomical and functional findings. Int J Oral Maxillofac Surg. 2001 Apr;30(2):123-9. doi: 10.1054/ijom.2000.0001.
PubMed 11405447Turvey TA, Hall DJ, Warren DW. Alterations in nasal airway resistance following superior repositioning of the maxilla. Am J Orthod. 1984 Feb;85(2):109-14. doi: 10.1016/0002-9416(84)90002-2.
PubMed 6594051
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Subspinal Le Fort I Osteotomy Affect the Nasal Airway Volume
- ClinicalTrials.gov ID
- NCT06281197
- Acronym / sponsor ID
- 2021/48
- Conditions
- Maxillofacial Abnormalities
- Keywords
- Subspinal Le Fort Osteotomy, Nasal airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 28 Feb 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.
After the description of Le Fort fractures, maxillary osteotomies are used to correct dentofacial deformities. The profile changes on nasolabial region resulting from a Le Fort I osteotomy, also that affects nasal airway. The Subspinal Le Fort I osteotomy (SLFIO) describe to prevent undesirable soft tissue changes. In the literature, too many articles have reported the effectiveness of SLFIO in preventing nasal deformation. However, there is no study to evaluate the nasal volume or septum deviation.
Detailed description
The purpose of this study was objectively and subjectively to compare the effect of Subspinal Le Fort I Osteotomy and Conventional Le Fort I Osteotomy on nasal airway volume and septum deviation without additional modification such as Ans Reduction, Alar Cinch Suture, V-Y closure.
Surgical procedure; Patients were underwent general anesthesia for bimaxillary orthognathic surgery.
The mucoperiosteal flap was raised to expose the bilateral infraorbital foramina, aperture pyriformis, zygomaticomaxillary, and pterygomaxillary buttress. No dissection was performed between the nasal mucosa and the ANS of the patients in Subspinal Le Fort osteotomy group.A triangular osteotomy line was created between the maxilla and the ANS with a piezosurgery. In Conventional osteotomy group, Le Fort I osteotomy was made using a piezosurgical saw after nasal mucosa elevation. In both groups, osteotomes and pterygoid plaques, nasal septum, and lateral nasal walls were separated.
Follow up:
septum deviation and nasal. airway volume value was measured and recorded in the CBCT images taken before the surgery and at the 6th month after the surgery of each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- double blind
| Arm | Type | Receives |
|---|---|---|
| Conventional Group | Experimental | Procedure: ConventionalIn conventional group, Le Fort I osteotomy was made using a piezosurgical saw after nasal mucosa elevation as usual Le Fort I technique. |
| Subspinal Group | Active comparator | Procedure: SubspinalIn Subspinal group, No dissection was performed between the nasal mucosa and the ANS of the patients. Osteotomy was performed in the subspinal Le Fort I group that is described by Mommaerts . A triangular osteotomy line was created between the maxilla and the ANS with a piezosurgery. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- aged 18-40, ASA I, without systemic disease, without any drug allergy, and without a history of NSAID use in the week before the operation.
Key exclusion criteria (1 listed)
- ASA II or higher, hepatic or renal dysfunction, neuropathic disease, long-term use of NSAIDs or opioid-derived drugs, a history of allergic reaction to drugs, pain, swelling, inflammation in the head and neck region before the operation, pregnant and breastfeeding with a history of cleft lip and palate and rhinoplasty 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 |
|---|---|---|
| ConventionalAlso: Group IILe Fort I osteotomy performed with conventional Le Fort | Procedure or surgery | Conventional Group |
| SubspinalAlso: Group IOsteotomy was performed in the subspinal Le Fort I group that is described by Mommaerts | Procedure or surgery | Subspinal Group |
Primary outcome
Evaluation of Septum Deviation
Time frame: up to six months
This angle value was measured and recorded in the CBCT images taken before the surgery and at the 6th month after the surgery of each patient. If the angle in the preoperative view is smaller than the angle in the postoperative view, there is a decrease in septum deviation; If it is large, it was accepted that there was an increase in septum deviation.
Evaluation of Nasal Airway
Time frame: up to six months
CBCT scans were scanned for anatomical landmarks to adjust the volume analyzed by automatic segmentation in NemoFAB. Dens endpoint of the axis and nasion were found to be the most consistent at the anterior cranial and posterior caudal borders in the mid-sagittal plane The lateral borders were determined as the most lateral part of the nasal cavity. These markers were used to define the cubic area of interest (ROI), which includes the cranial cavity up to the maxillary base. In the sagittal tomography section, the nasal airway volume was measured in cc on the section taken from the midline.
1 secondary outcome
nasal obstruction scale evaluation
Time frame: up to six 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 28 Feb 2024.
- Background: PubMed 6585148Guenthner TA, Sather AH, Kern EB. The effect of Le Fort I maxillary impaction on nasal airway resistance. Am J Orthod. 1984 Apr;85(4):308-15. doi: 10.1016/0002-9416(84)90188-x.
- Background: PubMed 28399616Galbiati G, Maspero C, Giannini L, Guenza GC, Zanoni F, Farronato G. Orthodontic--surgical treatment and respiratory function: rhinomanometric assessment. Minerva Stomatol. 2017 Jun;66(3):91-97. doi: 10.23736/S0026-4970.17.04045-6. Epub 2017 Apr 11.
- Background: PubMed 20625295Posnick JC, Agnihotri N. Consequences and management of nasal airway obstruction in the dentofacial deformity patient. Curr Opin Otolaryngol Head Neck Surg. 2010 Aug;18(4):323-31. doi: 10.1097/MOO.0b013e32833b9d6f.
- Background: PubMed 30247560Helal HA, Ghanem MAM, Al-Badawy AM, Abdel Haleem MM, Mousa MH. Histological and Anthropometric Changes in the Aging Nose. Aesthet Surg J. 2019 Aug 22;39(9):943-952. doi: 10.1093/asj/sjy245.
- Background: PubMed 3881034Schwarz GM, Thrash WJ, Byrd DL, Jacobs JD. Tomographic assessment of nasal septal changes following surgical-orthodontic rapid maxillary expansion. Am J Orthod. 1985 Jan;87(1):39-45. doi: 10.1016/0002-9416(85)90172-1.
- Background: PubMed 25244276Kaur S, Rai S, Kaur M. Comparison of reliability of lateral cephalogram and computed tomography for assessment of airway space. Niger J Clin Pract. 2014 Sep-Oct;17(5):629-36. doi: 10.4103/1119-3077.141431.
- Background: PubMed 24985958Goncales ES, Duarte MA, Palmieri C Jr, Zakhary GM, Ghali GE. Retrospective analysis of the effects of orthognathic surgery on the pharyngeal airway space. J Oral Maxillofac Surg. 2014 Nov;72(11):2227-40. doi: 10.1016/j.joms.2014.04.006. Epub 2014 Apr 13.
- Background: PubMed 291340Montgomery WM, Vig PS, Staab EV, Matteson SR. Computed tomography: a three-dimensional study of the nasal airway. Am J Orthod. 1979 Oct;76(4):363-75. doi: 10.1016/0002-9416(79)90223-9.
- Background: PubMed 9384792Kunkel M, Hochban W. The influence of maxillary osteotomy on nasal airway patency and geometry. Mund Kiefer Gesichtschir. 1997 Jul;1(4):194-8. doi: 10.1007/BF03043550.
- Background: PubMed 11405447Erbe M, Lehotay M, Gode U, Wigand ME, Neukam FW. Nasal airway changes after Le Fort I--impaction and advancement: anatomical and functional findings. Int J Oral Maxillofac Surg. 2001 Apr;30(2):123-9. doi: 10.1054/ijom.2000.0001.
- Background: PubMed 6594051Turvey TA, Hall DJ, Warren DW. Alterations in nasal airway resistance following superior repositioning of the maxilla. Am J Orthod. 1984 Feb;85(2):109-14. doi: 10.1016/0002-9416(84)90002-2.
- 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. 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 Conventional and Subspinal in people with Maxillofacial Abnormalities, run by TC Erciyes 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 1 inclusion and 1 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 28 Feb 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?
Evaluation of Septum Deviation (time frame: up to six months). The study lists 2 primary outcomes in all. 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 NCT06281197, which also lists 11 linked publications.
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 28 Feb 2024.