Exploring the Potential of Minimally Invasive Le Fort I Approach to Enhance Patient Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- TC Erciyes University
- Enrollment
- 47
- Locations
- 2
- Primary Endpoint
- Operative Time
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Minimally Invasive Le Fort I Osteotomy
Intervention: Minimally Invasive Le Fort I Osteotomy (Procedure)
Conventional Le Fort I Osteotomy
Intervention: Conventional Le Fort I Osteotomy (Procedure)
Outcomes
Primary Outcomes
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.
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.
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).
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
- Hospitalization(From the end of surgery until hospital discharge (typically within 48 hours))
- Pterygomaxillary Separation Pattern(Postoperative first day)
- Neurosensory Test: Upper Lip Sensation Recovery(Postoperative days 7, 14, and 30)
Investigators
İbrahim Mert Erkan
resident
TC Erciyes University