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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07279012). StuddyBuddy aggregates publicly available trial information.