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Completed
NCT07279012
Minimally Invasive Le Fort I Osteotomy
Conditions: Orthognathic Surgical Procedures
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 47
Sponsor: TC Erciyes University
Location: Erciyes University Faculty of Dentistry Department of Oral and Maxillofacial Surgery Kayseri
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07279012). StuddyBuddy aggregates publicly available trial information.