Skip to main content
OpenTrials
Completed

NCT Number: NCT07279012

Minimally Invasive Le Fort I Osteotomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Orthognathic Surgical Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University Faculty of Dentistry Department of Oral and Maxillofacial Surgery

Kayseri, 38039, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

Secondary outcomes

  1. Hospitalization

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

    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.

  2. Pterygomaxillary Separation Pattern

    Time frame: Postoperative first day

    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.

  3. Neurosensory Test: Upper Lip Sensation Recovery

    Time frame: Postoperative days 7, 14, and 30

    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.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

Exploring the Potential of Minimally Invasive Le Fort I Approach to Enhance Patient Outcomes

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.