Minimally Invasive Sagittal Split Ramus Osteotomy

Not Applicable

Completed

• Conditions: Orthognathic Surgical Procedures

• Registration Number: NCT07118605
• Lead Sponsor: TC Erciyes University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-19
• Primary Completion: 2024-07-25
• Study Completion: 2024-11-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-29
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-12
• Last Update Posted: 2025-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Bleeding	Intraoperative period (from skin incision to final suture placement)	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.
Operative Time	Intraoperative period (from skin incision to final suture placement)	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative Edema	Postoperative days 1, 7, 14, and 30	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).
Postoperative Pain	Postoperative hours 1, 2, 4, 6, 8, 10, 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, 4th, 6th, 8th, 10th, and 12th hours, and the results were recorded in the patient follow-up form.

Trial Locations

Locations (1)

Erciyes University Faculty of Dentistry Department of Oral and Maxillofacial Surgery; 🇹🇷 Kayseri, Turkey