Orthognathic Surgical ProceduresNCT07174193
Piezosurgery Versus Conventional Techniques in Orthognathic Surgery
A study testing Piezosurgery and Conventional techniques in people with Orthognathic Surgical Procedures and Piezoelectric Technique, run by Erasmus Medical Center at 2 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthognathic Surgical Procedures, Piezoelectric Technique
- What is being tested?
- Piezosurgery and Conventional techniques
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Oct 2025to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
4.2 Inclusion criteria
We will include:
- Dutch or English-speaking patients
- Patients 18-65 years of age
4.3 Exclusion criteria
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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites
Anna Ziekenhuis
Geldrop, 5664BE
Tim Knüppe, +31623384650, t.knuppe@erasmusmc.nl
Tim Knüppe, t.knuppe@erasmusmc.nl
Erasmus Medical Center
Rotterdam, 3015 GD
Tim Knüppe, +31623384650, t.knuppe@erasmusmc.nl
Tim Knüppe, t.knuppe@erasmusmc.nl
About this study
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:
Read more
- 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.
Read the detailed description
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.
Control arm: Osteotomy performed using a Lindemann burr for horizontal and vertical cuts, followed by a reciprocating saw to connect osteotomies.
The allocation ratio is 1:1, determined via block randomization in Castor EDC with variable block sizes (2, 4, and 6).
Blinding Participants will remain blinded to treatment allocation. Postoperative neurosensory assessments will be conducted by independent examiners blinded to group assignment.
Procedures All participants will undergo standardized preoperative assessment of inferior alveolar nerve function, including the static two-point discrimination test and a validated questionnaire on subjective sensory changes. Surgeries will be performed by experienced maxillofacial surgeons using the Hunsuck modification of the BSSO technique.
Intraoperative metrics will include surgical duration (from incision to final suture) and quantified blood loss (suction volume minus irrigation fluid plus gauze weight). Adverse intraoperative events such as "bad splits" will be documented. Postoperative infection will be defined according to CDC criteria.
Follow-up will occur at 1 week, 3 months, 6 months, and 12 months postoperatively. Neurosensory function will be reassessed at each visit, and the validated patient questionnaire will be completed at 3 months and 12 months.
Cost and Sustainability Assessment A life cycle cost analysis (LCC) will compare acquisition, operation, maintenance, and disposal costs between the two techniques. A life cycle assessment (LCA) will evaluate environmental impact, including CO₂ emissions, energy consumption, sterilization requirements, and waste generation.
Sample Size Sample size calculations were based on detecting clinically meaningful differences in operative time, blood loss, and nerve injury rates. The largest required sample size was 31 participants per group to detect differences in nerve impairment at 3-6 months with 80% power and α = 0.05.
Statistical Analysis Primary outcome (time to functional sensory recovery) will be analyzed using Kaplan-Meier survival curves and the log-rank test. Neurosensory scores will be compared using Chi-square or Fisher's exact tests. Continuous secondary outcomes will be analyzed using Student's t-test or Mann-Whitney U test depending on distribution. Categorical outcomes (e.g., bad split, infection) will be compared using Chi-square or Fisher's exact tests. The relationship between surgeon experience with piezosurgery and operative time will be explored using linear regression. A p-value < 0.05 will be considered statistically significant.
This trial is designed to provide robust evidence regarding both clinical and economic implications of adopting piezosurgery in orthognathic surgery.
- Being tested
- Piezosurgery, Conventional techniques
- Keywords
- orthognathic surgery, piezosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiezosurgeryDevice
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.
Conventional techniquesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Piezosurgery | Experimental | Patients undergoing BSSO with piezosurgery Receives: Device: Piezosurgery |
| Conventional group | Active comparator | Patients undergoing BSSO with conventional techniques Receives: Device: Conventional techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Operative time will be defined as the duration (in minutes) from the initial incision to the final suture.
Measured: Data will be gathered during surgery.
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.
Measured: Data will be gathered during surgery.
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.
Measured: Assessments will be done up to 1 year after surgery.
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.
Measured: 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.
Cost comparison between piezosurgery and conventional techniques will be performed using a life cycle costing (LCC). This analysis will include purchasing costs, device lifetime, cleaning costs, maintenance costs and waste disposal costs (26).
Measured: 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.
Life cycle assessment (LCA) will be used to evaluate the environmental impact of piezosurgery versus conventional techniques. LCA accounts for direct emissions during product use, as well as emissions during manufacturing and disposal processses (27).
Measured: 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.
Surgeon experience will be quantified by the number of osteotomies performed using piezosurgery. None of the participating surgeons routinely used piezosurgery in orthognathic surgery using piezosurgery prior to the start of this study.
Measured: Information will be gathered during surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthognathic Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Knuppe, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174193
- Sponsor's protocol ID
- PiezoOrthognathicSurgery
- Status last verified
- Sep 2025
- First submitted
- 10 Aug 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piezosurgery Versus Conventional Techniques in Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT07174193
- Acronym / sponsor ID
- PiezoOrthognathicSurgery
- Keywords
- orthognathic surgery, piezosurgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Control arm: Osteotomy performed using a Lindemann burr for horizontal and vertical cuts, followed by a reciprocating saw to connect osteotomies.
The allocation ratio is 1:1, determined via block randomization in Castor EDC with variable block sizes (2, 4, and 6).
Blinding Participants will remain blinded to treatment allocation. Postoperative neurosensory assessments will be conducted by independent examiners blinded to group assignment.
Procedures All participants will undergo standardized preoperative assessment of inferior alveolar nerve function, including the static two-point discrimination test and a validated questionnaire on subjective sensory changes. Surgeries will be performed by experienced maxillofacial surgeons using the Hunsuck modification of the BSSO technique.
Intraoperative metrics will include surgical duration (from incision to final suture) and quantified blood loss (suction volume minus irrigation fluid plus gauze weight). Adverse intraoperative events such as "bad splits" will be documented. Postoperative infection will be defined according to CDC criteria.
Follow-up will occur at 1 week, 3 months, 6 months, and 12 months postoperatively. Neurosensory function will be reassessed at each visit, and the validated patient questionnaire will be completed at 3 months and 12 months.
Cost and Sustainability Assessment A life cycle cost analysis (LCC) will compare acquisition, operation, maintenance, and disposal costs between the two techniques. A life cycle assessment (LCA) will evaluate environmental impact, including CO₂ emissions, energy consumption, sterilization requirements, and waste generation.
Sample Size Sample size calculations were based on detecting clinically meaningful differences in operative time, blood loss, and nerve injury rates. The largest required sample size was 31 participants per group to detect differences in nerve impairment at 3-6 months with 80% power and α = 0.05.
Statistical Analysis Primary outcome (time to functional sensory recovery) will be analyzed using Kaplan-Meier survival curves and the log-rank test. Neurosensory scores will be compared using Chi-square or Fisher's exact tests. Continuous secondary outcomes will be analyzed using Student's t-test or Mann-Whitney U test depending on distribution. Categorical outcomes (e.g., bad split, infection) will be compared using Chi-square or Fisher's exact tests. The relationship between surgeon experience with piezosurgery and operative time will be explored using linear regression. A p-value < 0.05 will be considered statistically significant.
This trial is designed to provide robust evidence regarding both clinical and economic implications of adopting piezosurgery in orthognathic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piezosurgery | Experimental | Device: PiezosurgeryPatients undergoing BSSO with piezosurgery |
| Conventional group | Active comparator | Device: Conventional techniquesPatients undergoing BSSO with conventional techniques |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PiezosurgeryInitially 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. | Device | Piezosurgery |
| Conventional techniquesIn 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. | Device | Conventional group |
Primary outcome
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.
Time frame: 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.
7 secondary outcomes
To evaluate the impact of piezosurgery on surgical duration in orthognathic procedures compared to conventional techniques.
Time frame: Data will be gathered during surgery.
To assess intraoperative blood loss associated with piezosurgery versus conventional techniques in orthognathic procedures.
Time frame: Data will be gathered during surgery.
To examine the incidence of postoperative infections following orthognathic procedures using piezosurgery compared to conventional techniques.
Time frame: Assessments will be done up to 1 year after surgery.
To compare the incidence of bad splits during BSSO between piezosurgery and conventional techniques.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Information will be gathered during surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Orthognathic Surgical Procedures
Recruiting
Accuracy of Maxillary Two Customized 3D Titanium Miniplates Versus Four Customized 3D Miniplates
Orthognathic Surgery
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Recruiting
Mandibular Medial Osteotomy Modifications and Postoperative Stability
Orthognathic Surgical Procedures
Recruiting
Effect of Proximal Segment Positioning on Condylar Remodeling
Orthognathic Surgical Procedures
Active, not recruitingObservational study
Comparative Evaluation of Functional and Aesthetic Outcomes of Box and Mini-Wing Genioplasty Techniques
Class II Malocclusion, Dentofacial Deformities
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piezosurgery and Conventional techniques in people with Orthognathic Surgical Procedures and Piezoelectric Technique, run by Erasmus Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tim Knüppe (+31623384650, t.knuppe@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Measurements will be done 1 week post-op, 3 months post-op, 6 months post-op and 1 year post-op.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.