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NCT Number: NCT07118605

Minimally Invasive Sagittal Split Ramus Osteotomy

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.

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Key information

Conditions

Orthognathic Surgical Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University Faculty of Dentistry Department of Oral and Maxillofacial Surgery

Kayseri, 38039, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Operative Time

    Time frame: 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.

  2. Bleeding

    Time frame: 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.

Secondary outcomes

  1. Postoperative Edema

    Time frame: 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).

  2. Postoperative Pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

Exploring the Potential of Minimally Invasive Sagittal Split Ramus Osteotomy to Transform Patient Outcomes: A Randomized, Double-Blind, Controlled Split Mouth Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 12, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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