Minimally Invasive Sagittal Split Ramus Osteotomy

TC Erciyes University36 enrolled

Overview

This randomized, double-blind, controlled, split-mouth clinical trial investigates the effects of two different surgical approaches - the conventional technique and a minimally invasive technique - during bilateral sagittal split ramus osteotomy (SSRO) for mandibular deformity correction. The study will be conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Erciyes University. Each patient will receive both surgical techniques, randomly assigned to either side of the mandible. All procedures will be performed under general anesthesia by the same surgeon. Intraoperative outcomes including bleeding volume and operative time will be recorded. Postoperative evaluations will be conducted on day 1, weeks 1, 2, and 4, and at 3 months to assess pain and swelling. This study aims to determine whether the minimally invasive SSRO technique can improve surgical efficiency and reduce postoperative morbidity compared to the conventional approach, without compromising treatment outcomes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Orthognathic Surgical Procedures

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who underwent sagittal split ramus osteotomy for mandibular dentofacial deformity * Patients classified as ASA I or II * 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 mandibular surgery due to trauma, tumors, or cysts and had sequelae involving the lower jaw

Outcomes

Primary Outcomes

Operative Time

Operative time will be measured in minutes, separately for the right and left sides, from the initial skin incision to the final suture placement, using a chronometer.

Time frame: Intraoperative period (from skin incision to final suture placement)

Bleeding

Bleeding volume will be measured in milliliters from the initial skin incision to the final suture placement, using separate calibrated aspirators for the left and right sides.

Time frame: Intraoperative period (from skin incision to final suture placement)

Secondary Outcomes

Postoperative Edema

The 3dMD imaging system (3dMD, Atlanta, GA) 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).

Time frame: Postoperative days 1, 7, 14, and 30

Postoperative Pain

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, 4th, 6th, 8th, 10th, and 12th hours, and the results were recorded in the patient follow-up form.

Time frame: Postoperative hours 1, 2, 4, 6, 8, 10, and 12