Piezosurgery Versus Conventional Techniques in Orthognathic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- 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.
研究概览
简要总结
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:
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Undergo preoperative assessment of inferior alveolar nerve function (two-point discrimination test, validated questionnaire).
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Be randomized into:
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Intervention group: BSSO performed entirely using piezosurgery.
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Control group: BSSO performed with conventional burr and saw techniques.
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Have their surgery performed by experienced maxillofacial surgeons following standardized protocols.
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Have operative time and blood loss recorded during surgery.
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Be followed up at 1 week, 3 months, 6 months, and 1 year for nerve function, sensory recovery, and infection assessment.
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Complete postoperative questionnaires on sensory changes at 3 months and 1 year.
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Have surgical outcomes evaluated by blinded examiners.
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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.
详细描述
This is a randomized, double-blinded controlled clinical trial designed to evaluate the efficacy, safety, cost-effectiveness, and environmental impact of piezosurgery compared to conventional osteotomy techniques in orthognathic surgery. The study focuses on patients undergoing bilateral sagittal split osteotomy (BSSO), either as a standalone procedure or combined with Le Fort I osteotomy (bimaxillary surgery).
Orthognathic surgery is a well-established treatment for dentofacial deformities, performed to correct occlusal discrepancies and improve both function and aesthetics. The conventional technique for mandibular osteotomy employs rotary and oscillating instruments, which may increase the risk of iatrogenic injury to the inferior alveolar nerve, intraoperative bleeding, and postoperative swelling. Piezosurgery, a technique utilizing ultrasonic microvibrations for selective bone cutting, has been proposed to minimize trauma to adjacent soft tissues, potentially reducing sensory deficits and improving recovery.
Study Rationale Preliminary evidence from smaller clinical studies suggests that piezosurgery may lower the incidence of inferior alveolar nerve impairment, reduce intraoperative bleeding, and lessen postoperative morbidity, but it may also increase operative time. Many prior studies have been limited by small sample sizes, heterogeneous methodologies, and lack of standardized neurosensory assessment. This trial addresses these limitations with adequate statistical power, standardized testing, and rigorous blinding procedures.
Intervention and Control
Intervention arm: All osteotomy cuts performed using piezosurgical devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •4.2 Inclusion criteria
- •We will include:
- •Dutch or English-speaking patients
- •Patients 18-65 years of age
排除标准
- •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
研究组 & 干预措施
Piezosurgery
Patients undergoing BSSO with piezosurgery
干预措施: Piezosurgery (Device)
Conventional group
Patients undergoing BSSO with conventional techniques
干预措施: Conventional techniques (Device)
结局指标
主要结局
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.
时间窗: Measurements will be done 1 week post-op, 3 months post-op, 6 months post-op and 1 year post-op.
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.
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.
时间窗: Measurements will be done 1 week post-op, 3 months post-op, 6 months post-op and 1 year post-op.
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.
次要结局
- 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.)
- To investigate the sustainability of piezosurgery in comparison with conventional techniques in orthognathic procedures using a life cylce assessment.(Data will be gathered one year after start of inclusion.)
- To investigate the influence of surgical experience with piezosurgery on procedure duration in orthognathic procedures.(Information will be gathered during surgery.)
- 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.)
- To investigate the sustainability of piezosurgery in comparison with conventional techniques in orthognathic procedures using a life cylce assessment.(Data will be gathered one year after start of inclusion.)
- To investigate the influence of surgical experience with piezosurgery on procedure duration in orthognathic procedures.(Information will be gathered during surgery.)
研究者
Tim Knuppe
Principal Investigator
Erasmus Medical Center