Piezosurgery Versus Conventional Techniques in Orthognathic Surgery

NCT07174193 | Not Yet Recruiting

• 1 other identifier: PiezoOrthognathicSurgery
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Orthognathic Surgical Procedures; Piezoelectric Technique

Keywords

orthognathic surgery; piezosurgery

Outcome Measures

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.

  Measurements will be done 1 week post-op, 3 months post-op, 6 months post-op and 1 year post-op.

Secondary Outcomes (7)

• To evaluate the impact of piezosurgery on surgical duration in orthognathic procedures compared to conventional techniques.

  Data will be gathered during surgery.

• To assess intraoperative blood loss associated with piezosurgery versus conventional techniques in orthognathic procedures.

  Data will be gathered during surgery.

• To examine the incidence of postoperative infections following orthognathic procedures using piezosurgery compared to conventional techniques.

  Assessments will be done up to 1 year after surgery.

• To compare the incidence of bad splits during BSSO between piezosurgery and conventional techniques.

  Data will be gathered during surgery.

• To analyze the costs associated with use of piezosurgery versus conventional techniques in orthognathic procedures using a life cycle costing model.

  Data will be gathered one year after start of inclusion.

Study Arms (2)

Piezosurgery

EXPERIMENTAL

Patients undergoing BSSO with piezosurgery

Device: Piezosurgery

Conventional group

ACTIVE COMPARATOR

Patients undergoing BSSO with conventional techniques

Device: Conventional techniques

Interventions

Piezosurgery DEVICE

Initially 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.

Piezosurgery

Conventional techniques DEVICE

In 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.

Conventional group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• We will include:
• Dutch or English-speaking patients
• Patients 18-65 years of age

You may not qualify if:

• The following patients will be excluded from the study:
• 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
• Patients with facial cleft(s) or other craniofacial anomalies
• Patients undergoing simultaneous genioplasty

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (2)

Anna Ziekenhuis

Geldrop, 5664BE, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3015 GD, Netherlands

Location

MeSH Terms

Interventions

Piezosurgery

Intervention Hierarchy (Ancestors)

Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Tim Knüppe

CONTACT

+31623384650; t.knuppe@erasmusmc.nl

Study Design

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

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: September 15, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

NL (2)