Piezosurgery Versus Conventional Techniques in Orthognathic Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorErasmus Medical Center

About this trial

The goal of this randomized double-blinded controlled clinical trial is to determine whether piezosurgery can reduce complications and improve outcomes compared to conventional osteotomy techniques in patients undergoing bilateral sagittal split osteotomy (BSSO), with or without concurrent Le Fort I osteotomy (bimaxillary surgery).

The main questions this study aims to answer are:

* Does piezosurgery reduce inferior alveolar nerve impairment following BSSO compared to conventional techniques? * Does piezosurgery affect surgical duration, intraoperative blood loss, rates of bad splits, postoperative infections, costs, and environmental sustainability compared to conventional techniques?

Researchers will compare BSSO performed with piezosurgery versus BSSO performed with conventional oscillating saw and burr techniques to see if piezosurgery leads to better sensory outcomes, reduced morbidity, and improved cost-effectiveness and sustainability.

Participants will be:

* Dutch or English-speaking adults aged 18-65 scheduled for BSSO or BIMAX surgery at Erasmus Medical Centre (Rotterdam) or St. Anna Hospital (Geldrop, Netherlands). * Exclusions include bone healing disorders, coagulation issues, facial trauma history, smoking, craniofacial anomalies, and planned simultaneous genioplasty.

Participants will:

* Undergo preoperative assessment of inferior alveolar nerve function (two-point discrimination test, validated questionnaire). * Be randomized into:

* Intervention group: BSSO performed entirely using piezosurgery. * Control group: BSSO performed with conventional burr and saw techniques. * Have their surgery performed by experienced maxillofacial surgeons following standardized protocols. * Have operative time and blood loss recorded during surgery. * Be followed up at 1 week, 3 months, 6 months, and 1 year for nerve function, sensory recovery, and infection assessment. * Complete postoperative questionnaires on sensory changes at 3 months and 1 year. * Have surgical outcomes evaluated by blinded examiners. * Contribute to a life cycle cost analysis (LCC) and life cycle assessment (LCA) comparing equipment cost, maintenance, energy use, waste generation, and environmental impact between techniques.

Eligibility criteria

Qualifiers

Dutch or English-speaking patients

Patients 18-65 years of age

Disqualifiers

Patients with any underlying comorbidities or medication use that may impair bone healing, i.e., radiotherapy in the head- and neck region or the use of antiresorptive drugs.

Patients with coagulation disorders or those using of anticoagulative medication

Patients with a history of facial trauma or previous facial surgery

Patients who smoke

Trial design

Treatments tested in this trial

  • Piezosurgery
  • Conventional techniques

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators