Minimally Invasive Sagittal Split Ramus Osteotomy

NCT07118605 | Completed

• 1 other identifier: 2024/110
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthognathic Surgical Procedures

Keywords

minimally invasive; sagittal split ramus osteotomy; orthognathic surgery; patient outcomes

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Intraoperative period (from skin incision to final suture placement)

Secondary Outcomes (2)

• Postoperative Edema

  Postoperative days 1, 7, 14, and 30

• Postoperative Pain

  Postoperative hours 1, 2, 4, 6, 8, 10, and 12

Study Arms (2)

Minimally Invasive Sagittal Split Ramus Osteotomy

EXPERIMENTAL

Procedure: Minimally Invasive Sagittal Split Ramus Osteotomy

Conventional Sagittal Split Ramus Osteotomy

ACTIVE COMPARATOR

Procedure: Conventional Sagittal Split Ramus Osteotomy

Interventions

Minimally Invasive Sagittal Split Ramus Osteotomy PROCEDURE

This procedure involves a limited mucosal incision and tunnel dissection technique combined with low and short osteotomy and minimal soft tissue manipulation. The goal is to reduce surgical trauma, edema, blood loss, and operative time while maintaining clinical effectiveness.

Minimally Invasive Sagittal Split Ramus Osteotomy

Conventional Sagittal Split Ramus Osteotomy PROCEDURE

This procedure follows the traditional wide exposure technique with full-thickness mucoperiosteal flap elevation. This method is widely accepted and serves as the control for comparison.

Conventional Sagittal Split Ramus Osteotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who underwent sagittal split ramus osteotomy for mandibular dentofacial deformity
• Patients classified as ASA I or II
• Patients over 18 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Faculty of Dentistry Department of Oral and Maxillofacial Surgery

Kayseri, 38039, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 12, 2025
• Study Start: February 19, 2024
• Primary Completion: July 25, 2024
• Study Completion: November 1, 2024
• Last Updated: August 12, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)