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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Piezosurgery
DeviceInitially introduced in the field of implantology, piezosurgery has gained increasing popularity in orthognathic surgery in recent years (7-9). This technique utilizes ultrasonic vibrations ranging from 60-210 μm/s at frequencies between 24-29 kHz to cut bone, thereby minimizing trauma to surrounding soft tissue (10). Although numerous studies have been conducted, many clinical investigations have been limited by small sample sizes and insufficiently described methodologies (17, 18). Furthermore, the lack of standardized assessment tools hinders reliable comparisons of outcomes across studies (19). While surgeons increasingly recommend the use of piezosurqical instruments in orthognathic surgery, robust evidence from the literature remains insufficient to support the change in surgical technique.
Conventional techniques
DeviceIn the control group a Lindemann burr will be used to perform the horizontal and vertical osteotomies and the cut at the lower border of the mandible. A reciprocal saw will then be used to connect the horizontal and vertical osteotomies in the sagittal plane.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: PiezosurgeryExperimental treatment 1 intervention
Group B: Conventional groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Inferior alveolar nerve impairment following BSSO measured using the static two-point discrimination test (Weber test). Functional recovery will be evaluated using the sensory evaluation scale.
Inferior alveolar nerve impairment will be assessed using the static two-point discrimination test (Weber test). The procedure will first be explained and demonstrated on the patients' hands to ensure comprehension. Testing will take place in a quiet room, with the patient seated and the eyes closed. A blinded examiner will perform the Weber test using a two-point discriminator to stimulate predetermined facial areas. Patients will be instructed to indicate whether they perceive one or two distinct points. To minimize variability due to inconsistent stimulus pressure, flexible calibrated filaments will be used. The reliability of neurosensory assessment will be reinforced by applying the staircase method, as described by Van der Cruysse et al.
Time frame
Measurements will be done 1 week post-op, 3 months post-op, 6 months post-op and 1 year post-op.Secondary outcomes
1
To evaluate the impact of piezosurgery on surgical duration in orthognathic procedures compared to conventional techniques.
Operative time will be defined as the duration (in minutes) from the initial incision to the final suture.
Time frame
Data will be gathered during surgery.2
To assess intraoperative blood loss associated with piezosurgery versus conventional techniques in orthognathic procedures.
Intraoperative blood loss will be quantified by measuring the volume (in mL) collected via suction, subtracting the amount of surgical rinsing and cooling fluid. Only intraoperative blood loss during a BSSO procedures will be considered to avoid result distortion from maxillary blood loss in BIMAX cases.
Time frame
Data will be gathered during surgery.3
To examine the incidence of postoperative infections following orthognathic procedures using piezosurgery compared to conventional techniques.
Surgical site infection (SSI) will be defined according to the criteria outlined by the Centers for Disease Control and Prevention (CDC). An SSI is diagnosed when osteosynthesis material is used and an infection occurs within one year postoperatively. Infections are identified by the presence of clinical symptoms and the need for antibiotic treatment.
Time frame
Assessments will be done up to 1 year after surgery.4
To compare the incidence of bad splits during BSSO between piezosurgery and conventional techniques.
Bad split is defined as an unfavorable and and unanticipated split pattern of the mandible that requires additional fixation techniques or may lead to the termination of the procedure.
Time frame
Data will be gathered during surgery.Sponsors and contacts
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Source ClinicalTrials.gov
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