Orthognathic Surgical ProceduresNCT07279012
Minimally Invasive Le Fort I Osteotomy
A study testing Minimally Invasive Le Fort I Osteotomy and Conventional Le Fort I Osteotomy in people with Orthognathic Surgical Procedures, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This is a single-center, prospective, randomized, controlled, and double-blind clinical study designed to evaluate the clinical outcomes of the minimally invasive Le Fort I osteotomy (MI-Le Fort I) compared with the conventional Le Fort I osteotomy (Le Fort I) in patients undergoing orthognathic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthognathic Surgical Procedures
- What is being tested?
- Minimally Invasive Le Fort I Osteotomy and Conventional Le Fort I Osteotomy
- 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
- 24 Feb 2022to 1 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent Le Fort I osteotomy for maxillary dentofacial deformity
- Patients classified as ASA I
- Patients over 18 years of age
Who cannot join
- Patients with uncontrolled diabetes
- Patients with metabolic bone diseases (e.g., hyperparathyroidism, Paget's disease)
- Patients with syndromic conditions (e.g., Pierre Robin syndrome, Treacher Collins syndrome)
- Patients who had previously undergone maxillary surgery due to trauma, tumors, or cysts and had sequelae involving the upper jaw
- Patients with a history of previous orthognathic surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University Faculty of Dentistry Department of Oral and Maxillofacial Surgery
Kayseri, 38039
About this study
Official title: Exploring the Potential of Minimally Invasive Le Fort I Approach to Enhance Patient Outcomes
This is a single-center, prospective, randomized, controlled, and double-blind clinical study designed to evaluate the clinical outcomes of the minimally invasive Le Fort I osteotomy (MI-Le Fort I) compared with the conventional Le Fort I osteotomy (Le Fort I) in patients undergoing orthognathic surgery.
Patients aged 18 to 40 years, classified as ASA I, will be randomly assigned to one of two groups: the MI-Le Fort I group or the Le Fort I group. Intraoperative parameters including blood loss (mL) and operative time (minutes) will be recorded. Postoperative facial swelling will be assessed using three-dimensional stereophotogrammetry, pain intensity will be measured with a visual analog scale (VAS). Additional outcomes will include hospitalization time, early recovery of upper lip sensation assessed by the pinprick test, and pterygomaxillary separation patterns evaluated using postoperative CBCT imaging.
The aim of this study is to compare the clinical outcomes of the MI-Le Fort I approach with the Le Fort I approach under controlled conditions. The study hypothesizes that the MI-Le Fort I osteotomy improves patient outcomes by minimizing soft tissue trauma without compromising surgical effectiveness.
- Conditions
- Orthognathic Surgical Procedures
- Being tested
- Minimally Invasive Le Fort I Osteotomy, Conventional Le Fort I Osteotomy
- Keywords
- minimally invasive, le fort I osteotomy, orthognathic surgery, patient outcomes, enhanced recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Le Fort I OsteotomyProcedure or surgery
Patients in this arm undergo the minimally invasive Le Fort I osteotomy (MI-Le Fort I). The procedure involves limited mucosal incision and soft tissue dissection. The pterygomaxillary separation is achieved through a frontal approach without osteotomizing the pterygoid plates. This technique aims to reduce surgical morbidity, intraoperative bleeding, and postoperative swelling compared to the conventional Le Fort I osteotomy.
Conventional Le Fort I OsteotomyProcedure or surgery
Patients in this arm undergo the conventional Le Fort I osteotomy technique. The procedure includes standard wide mucoperiosteal flap elevation and lateral maxillary wall exposure, followed by pterygomaxillary separation using a curved osteotome and mallet. This approach serves as the control group for comparison with the minimally invasive technique.
| Study group | Role | What they receive |
|---|---|---|
| Minimally Invasive Le Fort I Osteotomy | Experimental | Not described Receives: Procedure: Minimally Invasive Le Fort I Osteotomy |
| Conventional Le Fort I Osteotomy | Active comparator | Not described Receives: Procedure: Conventional Le Fort I Osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time
Operative time will be measured in minutes, from the initial mucosal incision to the final suture placement, using a chronometer.
Measured: Intraoperative period (from mucosal incision to final suture placement)
Bleeding
Bleeding volume will be measured in milliliters from the initial mucosal incision to the final suture placement, using a calibrated aspirator.
Measured: Intraoperative period (from mucosal incision to final suture placement)
Postoperative Edema
The 3dMD imaging system (3dMD, Atlanta, GA, USA) and 3dMD Vultus software were used to evaluate the amount of postoperative edema. Three-dimensional images were taken with the teeth in maximum intercuspation, lips relaxed, and eyes open on postoperative days 1, 7, 14, 30, and 90. Edema was calculated separately for the right and left sides and was recorded as surface area in square centimeters (cm²).
Measured: Postoperative days 1, 7, 14, 30 and 90
Postoperative Pain
Postoperative pain was evaluated using the Visual Analogue Scale for the right and left sides separately. In this scale, '0' meant no pain, and '100' represented maximum pain. Patients were questioned at postoperative 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th and 12th hours, and the results were recorded in the patient follow-up form.
Measured: Postoperative hours 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Secondary outcomes (3)
Hospitalization
The total postoperative hospitalization time (in hours) will be recorded for each participant. The measurement will cover the period from the end of surgery until hospital discharge.
Measured: From the end of surgery until hospital discharge (typically within 48 hours)
Pterygomaxillary Separation Pattern
The pterygomaxillary separation pattern will be evaluated using postoperative cone-beam computed tomography (CBCT) images. Each side will be classified according to the type of separation between the maxillary tuberosity and the pterygoid plates. The assessment aims to compare the frequency and characteristics of separation types between the minimally invasive Le Fort I osteotomy and the conventional Le Fort I osteotomy groups.
Measured: Postoperative first day
Neurosensory Test: Upper Lip Sensation Recovery
Recovery of upper lip sensation will be evaluated using the pinprick test applied bilaterally in the upper lip region. Each side will be scored on a five-point ordinal scale to determine the degree of infraorbital nerve recovery.
Measured: Postoperative days 7, 14, and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start24 Feb 2022
- Primary completion1 Aug 2024
- Study completion1 Nov 2024
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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, İbrahim Mert Erkan, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279012
- Sponsor's protocol ID
- 2022/190
- Status last verified
- Aug 2026
- First submitted
- 1 Dec 2025
- Last updated
- 20 Aug 2026
- Results posted
- 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Potential of Minimally Invasive Le Fort I Approach to Enhance Patient Outcomes
- ClinicalTrials.gov ID
- NCT07279012
- Acronym / sponsor ID
- 2022/190
- Conditions
- Orthognathic Surgical Procedures
- Keywords
- minimally invasive, le fort I osteotomy, orthognathic surgery, patient outcomes, enhanced recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 12 Dec 2025 (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 is a single-center, prospective, randomized, controlled, and double-blind clinical study designed to evaluate the clinical outcomes of the minimally invasive Le Fort I osteotomy (MI-Le Fort I) compared with the conventional Le Fort I osteotomy (Le Fort I) in patients undergoing orthognathic surgery.
Patients aged 18 to 40 years, classified as ASA I, will be randomly assigned to one of two groups: the MI-Le Fort I group or the Le Fort I group. Intraoperative parameters including blood loss (mL) and operative time (minutes) will be recorded. Postoperative facial swelling will be assessed using three-dimensional stereophotogrammetry, pain intensity will be measured with a visual analog scale (VAS). Additional outcomes will include hospitalization time, early recovery of upper lip sensation assessed by the pinprick test, and pterygomaxillary separation patterns evaluated using postoperative CBCT imaging.
The aim of this study is to compare the clinical outcomes of the MI-Le Fort I approach with the Le Fort I approach under controlled conditions. The study hypothesizes that the MI-Le Fort I osteotomy improves patient outcomes by minimizing soft tissue trauma without compromising surgical effectiveness.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally Invasive Le Fort I Osteotomy | Experimental | Procedure: Minimally Invasive Le Fort I Osteotomy |
| Conventional Le Fort I Osteotomy | Active comparator | Procedure: Conventional Le Fort I Osteotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who underwent Le Fort I osteotomy for maxillary dentofacial deformity
- Patients classified as ASA I
- Patients over 18 years of age
Key exclusion criteria (5 listed)
- Patients with uncontrolled diabetes
- Patients with metabolic bone diseases (e.g., hyperparathyroidism, Paget's disease)
- Patients with syndromic conditions (e.g., Pierre Robin syndrome, Treacher Collins syndrome)
- Patients who had previously undergone maxillary surgery due to trauma, tumors, or cysts and had sequelae involving the upper jaw
- Patients with a history of previous orthognathic 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 |
|---|---|---|
| Minimally Invasive Le Fort I OsteotomyPatients in this arm undergo the minimally invasive Le Fort I osteotomy (MI-Le Fort I). The procedure involves limited mucosal incision and soft tissue dissection. The pterygomaxillary separation is achieved through a frontal approach without osteotomizing the pterygoid plates. This technique aims to reduce surgical morbidity, intraoperative bleeding, and postoperative swelling compared to the conventional Le Fort I osteotomy. | Procedure or surgery | Minimally Invasive Le Fort I Osteotomy |
| Conventional Le Fort I OsteotomyPatients in this arm undergo the conventional Le Fort I osteotomy technique. The procedure includes standard wide mucoperiosteal flap elevation and lateral maxillary wall exposure, followed by pterygomaxillary separation using a curved osteotome and mallet. This approach serves as the control group for comparison with the minimally invasive technique. | Procedure or surgery | Conventional Le Fort I Osteotomy |
Primary outcome
Operative Time
Time frame: Intraoperative period (from mucosal incision to final suture placement)
Operative time will be measured in minutes, from the initial mucosal incision to the final suture placement, using a chronometer.
Bleeding
Time frame: Intraoperative period (from mucosal incision to final suture placement)
Bleeding volume will be measured in milliliters from the initial mucosal incision to the final suture placement, using a calibrated aspirator.
Postoperative Edema
Time frame: Postoperative days 1, 7, 14, 30 and 90
The 3dMD imaging system (3dMD, Atlanta, GA, USA) and 3dMD Vultus software were used to evaluate the amount of postoperative edema. Three-dimensional images were taken with the teeth in maximum intercuspation, lips relaxed, and eyes open on postoperative days 1, 7, 14, 30, and 90. Edema was calculated separately for the right and left sides and was recorded as surface area in square centimeters (cm²).
Postoperative Pain
Time frame: Postoperative hours 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Postoperative pain was evaluated using the Visual Analogue Scale for the right and left sides separately. In this scale, '0' meant no pain, and '100' represented maximum pain. Patients were questioned at postoperative 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th and 12th hours, and the results were recorded in the patient follow-up form.
3 secondary outcomes
Hospitalization
Time frame: From the end of surgery until hospital discharge (typically within 48 hours)
Pterygomaxillary Separation Pattern
Time frame: Postoperative first day
Neurosensory Test: Upper Lip Sensation Recovery
Time frame: Postoperative days 7, 14, and 30
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 20 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. 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 Minimally Invasive Le Fort I Osteotomy and Conventional Le Fort I Osteotomy in people with Orthognathic Surgical Procedures, 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 3 inclusion and 5 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 20 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?
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?
Operative Time (time frame: Intraoperative period (from mucosal incision to final suture placement)). The study lists 4 primary outcomes in all. 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 20 Aug 2026.