Minimally Invasive Le Fort I Osteotomy

TC Erciyes University

Status

Completed

Conditions

Orthognathic Surgical Procedures

Treatments

Procedure: Minimally Invasive Le Fort I Osteotomy

Procedure: Conventional Le Fort I Osteotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT07279012

2022/190

Details and patient eligibility

About

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.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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