NCT07279012

Minimally Invasive Le Fort I Osteotomy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: TC Erciyes University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Minimally Invasive Le Fort I Osteotomy	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.
PROCEDURE	Conventional Le Fort I Osteotomy	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.

Timeline

• Start date: 2022-02-24
• Primary completion: 2024-08-01
• Completion: 2024-11-01
• First posted: 2025-12-12
• Last updated: 2025-12-12

Locations

1 site across 1 country: Turkey (Türkiye)