Minimally Invasive Le Fort I Osteotomy

NCT07279012 | Completed

• 1 other identifier: 2022/190
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

minimally invasive; le fort I osteotomy; orthognathic surgery; patient outcomes; enhanced recovery

Outcome Measures

Primary Outcomes (4)

• Operative Time

  Operative time will be measured in minutes, from the initial mucosal incision to the final suture placement, using a chronometer.

  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.

  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).

  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.

  Postoperative hours 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

Secondary Outcomes (3)

• Hospitalization

  From the end of surgery until hospital discharge (typically within 48 hours)

• Pterygomaxillary Separation Pattern

  Postoperative first day

• Neurosensory Test: Upper Lip Sensation Recovery

  Postoperative days 7, 14, and 30

Study Arms (2)

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

Interventions

Minimally Invasive Le Fort I Osteotomy PROCEDURE

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.

Minimally Invasive Le Fort I Osteotomy

Conventional Le Fort I Osteotomy PROCEDURE

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.

Conventional Le Fort I Osteotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who underwent Le Fort I osteotomy for maxillary dentofacial deformity
• Patients classified as ASA I
• Patients over 18 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Faculty of Dentistry Department of Oral and Maxillofacial Surgery

Kayseri, 38039, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: February 24, 2022
• Primary Completion: August 1, 2024
• Study Completion: November 1, 2024
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)