Maxillofacial DeformityNCT07549659
a Comparative Analysis of Subspinal and Conventional Le Fort I Osteotomy on Nasolabial Soft Tissues
A study testing conventional le fort I osteotomy type and subspinal le fort I osteotomy type in people with Maxillofacial Deformity and Maxillofacial Abnormalities, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Following surgical operations, patients have aesthetic expectations as well as functional ones. To minimize undesirable aesthetic results after surgery and to increase the effectiveness of the surgery, the surgical method used for maximum aesthetic results is important, both in pre-operative planning and during… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillofacial Deformity, Maxillofacial Abnormalities, Maxillo-facial Surgery
- What is being tested?
- conventional le fort I osteotomy type and subspinal le fort I osteotomy type
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2021to 15 Jun 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I,
- without systemic disease,
- without any drug allergy,
- and without a history of NSAID use in the week before the operation,
- patients in both groups did not apply alar cinch suture, V-Y closure, or ANS reduction
Who cannot join
- history of cleft lip palate and rhinoplasty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Subspinal Le Fort and Conventional Le Fort I Osteotomy on Nasolabial Soft Tissues
Following surgical operations, patients have aesthetic expectations as well as functional ones. To minimize undesirable aesthetic results after surgery and to increase the effectiveness of the surgery, the surgical method used for maximum aesthetic results is important, both in pre-operative planning and during surgery. In addition, effective control of bleeding and subsequent edema during surgical operations is a high priority for clinical research in surgical applications. Controlling edema and soft tissue damage improves the quality of life of patients after surgery, reduces morbidity and provides greater comfort, and also allows patients to recover quickly and return to their daily activities sooner. Although the developing edema is temporary, it is known to cause serious depressive disorders in some patients. Minimally invasive approach and maximum aesthetic results during surgery are affected by the surgical technique. This study will contribute to the literature by comparing subspinal Le Fort osteotomy with conventional osteotomy.
Read the detailed description
In this study, the effect of the type of osteotomy used in the osteotomy phase of orthognathic surgery on the changing parameters (bleeding, edema, soft tissue changes, etc.) during and after surgery will be investigated. While comparing conventional Le Fort I osteotomy with subspinal Le Fort I osteotomy, the advantages and disadvantages of the surgical techniques in the intraoperative and postoperative periods will be determined. This will be the first study to evaluate nasolabial soft tissue changes after subspinal Le Fort osteotomy and to subjectively and objectively compare it with conventional osteotomy performed without v-y closure and cinch sutures, and to evaluate the effect of both methods on postoperative edema. Subspinal Le Fort osteotomy is thought to minimize the widening of the nasal floor. This study has a unique value because it not only evaluates the soft tissue effectiveness of Le Fort osteotomy methods but also provides a three-dimensional comparison of these variables and a subjective explanation. Simultaneously comparing many parameters during and after surgery, and thanks to the results obtained from this study, it will contribute to increasing both the in-operative comfort of oral surgeons and the post-operative comfort of patients. the result of this study, subspinal Le Fort osteotomy will reduce bleeding by reducing dissection during surgery, minimize damage to soft tissues, and prevent unwanted soft tissue changes after surgery.
- Being tested
- conventional le fort I osteotomy type, subspinal le fort I osteotomy type
- Keywords
- subspinal osteotomy, edema, nasolabial changes
- Medical subject headings
- Maxillofacial Abnormalities, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional le fort I osteotomy typeProcedure or surgery
that performed with conventional Le Fort I
subspinal le fort I osteotomy typeProcedure or surgery
Osteotomy was performed in the subspinal Le Fort I group that is described by Mommaerts
| Study group | Role | What they receive |
|---|---|---|
| CLFI (conventional Le fort I osteotomy ) | Active comparator | CLFI was performed as usual Bell WH methods . The maxillary osteotomy was performed from nasal buttress to pterygomaxiller junction by piezosurgery in both groups. Bilateral pterygoid splits were performed with a chisel. After down fracture, bony interferences were removed and maxilla was fixed with miniplates and screws in its new position. ANS repositioning or recounturing, alar cinch suture and V-Y closure were not applied at all. Receives: Procedure: conventional le fort I osteotomy type |
| SLFI (Subspinal Le Fort I Osteotomy ) | Experimental | SLFI was performed, preventing the pre-existing nasal muscle origins. V-shaped osteotomy at the base of the ANS through a vestibular incision was existed in SLFI. ANS was never exposed to preserve the attachments and periost. Then, the nasal septum and lateral nasal walls were separated by appropriate osteotomes. After this osteotomy, the ANS was separated from the maxilla so that the ANS remains in its former position, hence it is not affected by maxillary movements. To be perpetuated the effectiveness of myrtiformis muscle, that muscle was remained in its former position Receives: Procedure: subspinal le fort I osteotomy type |
What is being measured
The primary outcome is the main question the study is designed to answer.
nasal base width
Nasal base width refers to the transverse distance between the most lateral points of the alar bases, reflecting the overall width of the nasal foundation at the level of the nostrils.
Measurement:
It is measured as the linear distance between the right and left alare (al-al) points on frontal view photographs or 3D images, typically using digital calipers or imaging software.
Measured: up to six months
alar base width
Alar base width is defined as the horizontal distance between the most lateral insertion points of the alar bases where the nostrils meet the cheek.
Measurement:
It is measured as the linear distance between the right and left alare (al-al) landmarks on frontal photographs or 3D stereophotogrammetric images, using calibrated digital software or calipers.
Measured: up to six months
upper lip length
Upper lip length is defined as the vertical distance between the subnasale and the labiale superius, representing the height of the upper lip in the midline.
Measurement:
It is measured as the linear distance from subnasale (Sn) to labiale superius (Ls) on profile or frontal images using digital measurement software or calipers.
Measured: up to six months
nasolabial angle
Nasolabial angle is the angle formed between the columella and the upper lip, reflecting the anteroposterior position and rotation of the nasal tip relative to the upper lip.
Measurement:
It is measured as the angle between a line drawn from subnasale to columella (columellar tangent) and a line from subnasale to labiale superius on lateral profile images or cephalometric analysis.
Measured: up to six monts
columellalobular angle
Columellalobular angle is the angle formed between the columella and the infratip lobule, reflecting the contour and transition between the nasal tip and columella.
Measurement:
It is measured as the angle between the columellar line and the infratip lobular line on lateral profile photographs or 3D images using digital analysis software.
Measured: up to six months
nasal tip angle
Nasal tip angle is defined as the angle formed at the pronasale by the intersection of lines extending from the nasion to the pronasale and from the pronasale to the columella, reflecting nasal tip projection and rotation.
Measurement:
It is measured on lateral profile images as the angle between the nasion-pronasale line and the pronasale-columella line using digital software or cephalometric analysis tools.
Measured: up to six months
nostril width
Nostril width is defined as the maximum horizontal distance across an individual nostril, reflecting the transverse dimension of the nostril aperture.
Measurement:
It is measured as the widest distance between the medial and lateral borders of the nostril on basal view photographs or 3D images using calibrated digital software or calipers.
Measured: up to six months
Secondary outcomes (2)
edema
Also, the images were used to compare postoperative edema between the groups. To determine even the minutest difference between the two groups, three-dimensional (3D) images were taken at preoperatively and postoperatively on 1, 3, 7, 14, 21, 30 day, 3 month and 6 month after surgery at maximum intercuspidation when the lips were free and the eyes were open
Measured: up to six months
rhinoplasty outcome evaluation (roe scale)
The Rhinoplasty Outcome Evaluation is a patient-reported outcome measure designed to assess satisfaction with nasal appearance and function following rhinoplasty.
Measurement:
It consists of 6 questions, each scored from 0 (most negative) to 4 (most positive); the total score is summed, divided by the maximum possible score (24), and multiplied by 100 to yield a percentage score ranging from 0 to 100, where higher scores indicate greater patient satisfaction.
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 posted24 Apr 2026
- Study start15 Jan 2021
- Primary completion25 Dec 2021
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Maxillofacial DeformityStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Model description
- double blind
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 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
- NCT07549659
- Sponsor's protocol ID
- 2021/048
- Other IDs
- TDH-2021-11020
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mommaerts MY, Abeloos JVS, De Clercq CAS. Comparison of two different techniques to control nasal base width and tip projection in Le Fort I-type osteotomies. J Craniomaxillofac Surg 1994;22:41.
Mansour S, Burstone C, Legan H. An evaluation of soft-tissue changes resulting from Le Fort I maxillary surgery. Am J Orthod. 1983 Jul;84(1):37-47. doi: 10.1016/0002-9416(83)90146-x.
PubMed 6575616Yamashsita Y, Iwai T, Honda K, Fujita K, Imai H, Takasu H, Omura S, Hirota M, Mitsudo K. Effectiveness of subspinal Le Fort I osteotomy in preventing postoperative nasal deformation. J Plast Reconstr Aesthet Surg. 2020 Jul;73(7):1326-1330. doi: 10.1016/j.bjps.2020.02.014. Epub 2020 Feb 17.
PubMed 32197886Davidson E, Kumar AR. A Preliminary Three-Dimensional Analysis of Nasal Aesthetics Following Le Fort I Advancement in Patients With Cleft Lip and Palate. J Craniofac Surg. 2015 Oct;26(7):e629-33. doi: 10.1097/SCS.0000000000002102.
PubMed 26468849San Miguel Moragas J, Van Cauteren W, Mommaerts MY. A systematic review on soft-to-hard tissue ratios in orthognathic surgery part I: maxillary repositioning osteotomy. J Craniomaxillofac Surg. 2014 Oct;42(7):1341-51. doi: 10.1016/j.jcms.2014.03.024. Epub 2014 May 21.
PubMed 25023781Miloro M, Ghali GE, Larsen PE, Waite PD. Peterson's principles of oral and maxillofacial surgery. vol. 1. Springer; 2004.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Subspinal Le Fort and Conventional Le Fort I Osteotomy on Nasolabial Soft Tissues
- ClinicalTrials.gov ID
- NCT07549659
- Acronym / sponsor ID
- 2021/048
- Keywords
- subspinal osteotomy, edema, nasolabial changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 25 Dec 2021 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 24 Apr 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.
Following surgical operations, patients have aesthetic expectations as well as functional ones. To minimize undesirable aesthetic results after surgery and to increase the effectiveness of the surgery, the surgical method used for maximum aesthetic results is important, both in pre-operative planning and during surgery. In addition, effective control of bleeding and subsequent edema during surgical operations is a high priority for clinical research in surgical applications. Controlling edema and soft tissue damage improves the quality of life of patients after surgery, reduces morbidity and provides greater comfort, and also allows patients to recover quickly and return to their daily activities sooner. Although the developing edema is temporary, it is known to cause serious depressive disorders in some patients. Minimally invasive approach and maximum aesthetic results during surgery are affected by the surgical technique. This study will contribute to the literature by comparing subspinal Le Fort osteotomy with conventional osteotomy.
Detailed description
In this study, the effect of the type of osteotomy used in the osteotomy phase of orthognathic surgery on the changing parameters (bleeding, edema, soft tissue changes, etc.) during and after surgery will be investigated. While comparing conventional Le Fort I osteotomy with subspinal Le Fort I osteotomy, the advantages and disadvantages of the surgical techniques in the intraoperative and postoperative periods will be determined. This will be the first study to evaluate nasolabial soft tissue changes after subspinal Le Fort osteotomy and to subjectively and objectively compare it with conventional osteotomy performed without v-y closure and cinch sutures, and to evaluate the effect of both methods on postoperative edema. Subspinal Le Fort osteotomy is thought to minimize the widening of the nasal floor. This study has a unique value because it not only evaluates the soft tissue effectiveness of Le Fort osteotomy methods but also provides a three-dimensional comparison of these variables and a subjective explanation. Simultaneously comparing many parameters during and after surgery, and thanks to the results obtained from this study, it will contribute to increasing both the in-operative comfort of oral surgeons and the post-operative comfort of patients. the result of this study, subspinal Le Fort osteotomy will reduce bleeding by reducing dissection during surgery, minimize damage to soft tissues, and prevent unwanted soft tissue changes after surgery.
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 |
|---|---|---|
| CLFI (conventional Le fort I osteotomy ) | Active comparator | Procedure: conventional le fort I osteotomy typeCLFI was performed as usual Bell WH methods . The maxillary osteotomy was performed from nasal buttress to pterygomaxiller junction by piezosurgery in both groups. Bilateral pterygoid splits were performed with a chisel. After down fracture, bony interferences were removed and maxilla was fixed with miniplates and screws in its new position. ANS repositioning or recounturing, alar cinch suture and V-Y closure were not applied at all. |
| SLFI (Subspinal Le Fort I Osteotomy ) | Experimental | Procedure: subspinal le fort I osteotomy typeSLFI was performed, preventing the pre-existing nasal muscle origins. V-shaped osteotomy at the base of the ANS through a vestibular incision was existed in SLFI. ANS was never exposed to preserve the attachments and periost. Then, the nasal septum and lateral nasal walls were separated by appropriate osteotomes. After this osteotomy, the ANS was separated from the maxilla so that the ANS remains in its former position, hence it is not affected by maxillary movements. To be perpetuated the effectiveness of myrtiformis muscle, that muscle was remained in its former position |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ASA I,
- without systemic disease,
- without any drug allergy,
- and without a history of NSAID use in the week before the operation,
- patients in both groups did not apply alar cinch suture, V-Y closure, or ANS reduction
Key exclusion criteria (1 listed)
- history of cleft lip palate and 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 |
|---|---|---|
| conventional le fort I osteotomy typethat performed with conventional Le Fort I | Procedure or surgery | CLFI (conventional Le fort I osteotomy ) |
| subspinal le fort I osteotomy typeOsteotomy was performed in the subspinal Le Fort I group that is described by Mommaerts | Procedure or surgery | SLFI (Subspinal Le Fort I Osteotomy ) |
Primary outcome
nasal base width
Time frame: up to six months
Nasal base width refers to the transverse distance between the most lateral points of the alar bases, reflecting the overall width of the nasal foundation at the level of the nostrils. Measurement: It is measured as the linear distance between the right and left alare (al-al) points on frontal view photographs or 3D images, typically using digital calipers or imaging software.
alar base width
Time frame: up to six months
Alar base width is defined as the horizontal distance between the most lateral insertion points of the alar bases where the nostrils meet the cheek. Measurement: It is measured as the linear distance between the right and left alare (al-al) landmarks on frontal photographs or 3D stereophotogrammetric images, using calibrated digital software or calipers.
upper lip length
Time frame: up to six months
Upper lip length is defined as the vertical distance between the subnasale and the labiale superius, representing the height of the upper lip in the midline. Measurement: It is measured as the linear distance from subnasale (Sn) to labiale superius (Ls) on profile or frontal images using digital measurement software or calipers.
nasolabial angle
Time frame: up to six monts
Nasolabial angle is the angle formed between the columella and the upper lip, reflecting the anteroposterior position and rotation of the nasal tip relative to the upper lip. Measurement: It is measured as the angle between a line drawn from subnasale to columella (columellar tangent) and a line from subnasale to labiale superius on lateral profile images or cephalometric analysis.
columellalobular angle
Time frame: up to six months
Columellalobular angle is the angle formed between the columella and the infratip lobule, reflecting the contour and transition between the nasal tip and columella. Measurement: It is measured as the angle between the columellar line and the infratip lobular line on lateral profile photographs or 3D images using digital analysis software.
nasal tip angle
Time frame: up to six months
Nasal tip angle is defined as the angle formed at the pronasale by the intersection of lines extending from the nasion to the pronasale and from the pronasale to the columella, reflecting nasal tip projection and rotation. Measurement: It is measured on lateral profile images as the angle between the nasion-pronasale line and the pronasale-columella line using digital software or cephalometric analysis tools.
nostril width
Time frame: up to six months
Nostril width is defined as the maximum horizontal distance across an individual nostril, reflecting the transverse dimension of the nostril aperture. Measurement: It is measured as the widest distance between the medial and lateral borders of the nostril on basal view photographs or 3D images using calibrated digital software or calipers.
2 secondary outcomes
edema
Time frame: up to six months
rhinoplasty outcome evaluation (roe scale)
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 24 Apr 2026.
- Results publicationMommaerts MY, Abeloos JVS, De Clercq CAS. Comparison of two different techniques to control nasal base width and tip projection in Le Fort I-type osteotomies. J Craniomaxillofac Surg 1994;22:41.
- Results publication: PubMed 6575616Mansour S, Burstone C, Legan H. An evaluation of soft-tissue changes resulting from Le Fort I maxillary surgery. Am J Orthod. 1983 Jul;84(1):37-47. doi: 10.1016/0002-9416(83)90146-x.
- Results publication: PubMed 32197886Yamashsita Y, Iwai T, Honda K, Fujita K, Imai H, Takasu H, Omura S, Hirota M, Mitsudo K. Effectiveness of subspinal Le Fort I osteotomy in preventing postoperative nasal deformation. J Plast Reconstr Aesthet Surg. 2020 Jul;73(7):1326-1330. doi: 10.1016/j.bjps.2020.02.014. Epub 2020 Feb 17.
- Results publication: PubMed 26468849Davidson E, Kumar AR. A Preliminary Three-Dimensional Analysis of Nasal Aesthetics Following Le Fort I Advancement in Patients With Cleft Lip and Palate. J Craniofac Surg. 2015 Oct;26(7):e629-33. doi: 10.1097/SCS.0000000000002102.
- Results publication: PubMed 25023781San Miguel Moragas J, Van Cauteren W, Mommaerts MY. A systematic review on soft-to-hard tissue ratios in orthognathic surgery part I: maxillary repositioning osteotomy. J Craniomaxillofac Surg. 2014 Oct;42(7):1341-51. doi: 10.1016/j.jcms.2014.03.024. Epub 2014 May 21.
- Results publicationMiloro M, Ghali GE, Larsen PE, Waite PD. Peterson's principles of oral and maxillofacial surgery. vol. 1. Springer; 2004.
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 le fort I osteotomy type and subspinal le fort I osteotomy type in people with Maxillofacial Deformity and 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 5 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 24 Apr 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?
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?
nasal base width (time frame: up to six months). The study lists 7 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 NCT07549659, which also lists 6 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 24 Apr 2026; AzTrials last refreshed its copy on 2 Nov 2026.