Surgical ComplicationNCT05205616
Trial of Bilateral Sagittal Split Osteotomy Induced Paresthesia Using Ultrasonic vs. Reciprocating Saw Instrumentation
A study testing Sonopet ultrasonic saw and Reciprocating saw in people with Surgical Complication and Paresthesia, run by University of California, San Francisco at 2 sites in United States.
Trial summary
The aim of this prospective study is to analyze the postoperative paresthesias experienced in patients who undergo bilateral sagittal split osteotomies (BSSO) using an ultrasonic saw, versus a reciprocating saw. Read more about this study
- Who is it for?
- Ages Up to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Complication, Paresthesia, Fracture
- What is being tested?
- Sonopet ultrasonic saw and Reciprocating saw
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Jul 2021to 25 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Must be undergoing bilateral sagittal split osteotomy surgery with Dr. Saghezchi at UCSF
- Must agree to return for all follow up visits.
- Must not have any preexisting V3 nerve paresthesia
- Must be below the age of 45.
Who cannot join
- Persons with preexisting V3 nerve paresthesias
- Pre-pubertal children will be excluded (per routine practice for this type of surgery).
- Patients with syndromic genetic conditions that demonstrate clearly different anatomy in the two sides of their jaws will be excluded since the two sides may not be "exchangeable".
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, San Francisco Medical Center
San Francisco, California, 94143
UCSF Benioff Children's Hospital
San Francisco, California, 94158
About this study
Official title: In-person Randomized Control Trial of the Incidence of Postoperative Hypoesthesia Among Bilateral Sagittal Split Osteotomy Patients Treated With Ultrasonic vs. Reciprocating Saw Instrumentation
The aim of this prospective study is to analyze the postoperative paresthesias experienced in patients who undergo bilateral sagittal split osteotomies (BSSO) using an ultrasonic saw, versus a reciprocating saw. Patients included in the study are ages 15-45 scheduled to undergo BSSO surgery at the University of California, San Francisco. One side of the patient's mandible will be instrumented with either the Stryker Sonopet ultrasonic saw or traditional reciprocating saw, while the other side will receive the remaining intervention (determined via randomization on the day of surgery). Patient paresthesias will then be analyzed on each side for 3 months postoperatively (at postoperative days: 1, 7, 14, 28, and 84). Sensory examinations will be carried out by blinded examiners using von Frey hairs and two point discrimination testing. Patients will also subjectively rate their sensation on each side. The results will then be analyzed to determine if patient paresthesias, including the severity and duration, differed depending on which instrument was used, the ultrasonic or reciprocating saw.
- Conditions
- Surgical Complication, Paresthesia, Fracture, Nerve Injury, Nerve Entrapments, Mandibular Nerve Injuries
- Being tested
- Sonopet ultrasonic saw, Reciprocating saw
- Keywords
- Paresthesia, BSSO, Bilateral Saggital Split Osteotomy, Unfavorable split, Unfavorable fracture, Inferior Alveolar Nerve, Reciprocating Saw, Ultrasonic Saw, Pair matched, Randomized Control Trial
- Medical subject headings
- Paresthesia, Fractures, Bone, Nerve Compression Syndromes, Mandibular Nerve Injuries, Micrognathism, Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonopet ultrasonic sawDevice
Ultrasonic saw to be used on a randomized side of the mandible, reciprocating saw will be used on other side
Reciprocating sawDevice
See above description
| Study group | Role | What they receive |
|---|---|---|
| Reciprocating saw | Placebo comparator | The traditional surgical instrument used for cutting bilateral sagittal split osteotomies Receives: Device: Reciprocating saw |
| Sonopet ultrasonic saw | Active comparator | This instrument is being compared to the reciprocating saw Receives: Device: Sonopet ultrasonic saw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Hypoesthesia Experienced at 3months
Count of patient mandibles who exhibited any hypoesthesia at 3months post-operation (i.e. VFH does not equal 0.008g). VFH filaments measure the minimum weight which a dermatome in question can sense. In this study, the measurements were designed to have the following range: 0.008g, 0.02g, 0.04g, 0.07g, 0.16g, 0.4g, 0.6g, 1g, 1.4g, 2g, 4g, 6g, 8g, 10g, 15g, with 0.008g being no neurosensory deficit. Although 28 persons completed the study, only 21 patients presented for their 3 month followup time, which was defined as with-in 15 days of 90th day after operation. Therefore, the denominator for this outcome is 21, for each intervention arm. The numerator is the number of Left or Right chin areas that exhibited less than "normal" sensation.
Measured: Within 15 days of exact 3 months post-operation
Secondary outcomes (1)
Unfavorable Fracture
When a saggital split osteotomy is performed, a controlled fracture of the mandibular ramus is induced which follows an exact intended path of fracture. An unfavorable fracture is one that does not follow this exact path of fracture, and needs to be surgically mended. An unfavorable fracture is associated with poorer post-operative recovery.
Measured: This outcome occurs during the surgery. It was measured on the same day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start20 Jul 2021
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical ComplicationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A matched-pair (with-in person) RCT design will be used, wherein one mandibular side (right versus left) in each patient will be randomized to be treated with Sonopet ultrasonic device (with the remaining side being treated with reciprocating saw). Neurosensory impairment, as herein described, will be compared at various post-operative times for a total follow-up of 3 months for each patients. Patients and the researchers examining patients post-operatively will be blinded.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sohail Saghezchi, DDS, MD, Principal investigator, UC San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205616
- Sponsor's protocol ID
- 21-33674
- Status last verified
- Jun 2025
- First submitted
- 11 Jan 2022
- Last updated
- 4 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-person Randomized Control Trial of the Incidence of Postoperative Hypoesthesia Among Bilateral Sagittal Split Osteotomy Patients Treated With Ultrasonic vs. Reciprocating Saw Instrumentation
- ClinicalTrials.gov ID
- NCT05205616
- Acronym / sponsor ID
- 21-33674
- Conditions
- Surgical Complication, Paresthesia, Fracture, Nerve Injury, Nerve Entrapments, Mandibular Nerve Injuries
- Keywords
- Paresthesia, BSSO, Bilateral Saggital Split Osteotomy, Unfavorable split, Unfavorable fracture, Inferior Alveolar Nerve, Reciprocating Saw, Ultrasonic Saw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 25 Jan 2022 (actual)
- Results
- Posted 4 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this prospective study is to analyze the postoperative paresthesias experienced in patients who undergo bilateral sagittal split osteotomies (BSSO) using an ultrasonic saw, versus a reciprocating saw. Patients included in the study are ages 15-45 scheduled to undergo BSSO surgery at the University of California, San Francisco. One side of the patient's mandible will be instrumented with either the Stryker Sonopet ultrasonic saw or traditional reciprocating saw, while the other side will receive the remaining intervention (determined via randomization on the day of surgery). Patient paresthesias will then be analyzed on each side for 3 months postoperatively (at postoperative days: 1, 7, 14, 28, and 84). Sensory examinations will be carried out by blinded examiners using von Frey hairs and two point discrimination testing. Patients will also subjectively rate their sensation on each side. The results will then be analyzed to determine if patient paresthesias, including the severity and duration, differed depending on which instrument was used, the ultrasonic or reciprocating saw.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A matched-pair (with-in person) RCT design will be used, wherein one mandibular side (right versus left) in each patient will be randomized to be treated with Sonopet ultrasonic device (with the remaining side being treated with reciprocating saw). Neurosensory impairment, as herein described, will be compared at various post-operative times for a total follow-up of 3 months for each patients. Patients and the researchers examining patients post-operatively will be blinded.
| Arm | Type | Receives |
|---|---|---|
| Reciprocating saw | Placebo comparator | Device: Reciprocating sawThe traditional surgical instrument used for cutting bilateral sagittal split osteotomies |
| Sonopet ultrasonic saw | Active comparator | Device: Sonopet ultrasonic sawThis instrument is being compared to the reciprocating saw |
Who may qualify
- Ages
- Up to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Must be undergoing bilateral sagittal split osteotomy surgery with Dr. Saghezchi at UCSF
- Must agree to return for all follow up visits.
- Must not have any preexisting V3 nerve paresthesia
- Must be below the age of 45.
Key exclusion criteria (3 listed)
- Persons with preexisting V3 nerve paresthesias
- Pre-pubertal children will be excluded (per routine practice for this type of surgery).
- Patients with syndromic genetic conditions that demonstrate clearly different anatomy in the two sides of their jaws will be excluded since the two sides may not be "exchangeable".
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 |
|---|---|---|
| Sonopet ultrasonic sawUltrasonic saw to be used on a randomized side of the mandible, reciprocating saw will be used on other side | Device | Sonopet ultrasonic saw |
| Reciprocating sawSee above description | Device | Reciprocating saw |
Primary outcome
Postoperative Hypoesthesia Experienced at 3months
Time frame: Within 15 days of exact 3 months post-operation
Count of patient mandibles who exhibited any hypoesthesia at 3months post-operation (i.e. VFH does not equal 0.008g). VFH filaments measure the minimum weight which a dermatome in question can sense. In this study, the measurements were designed to have the following range: 0.008g, 0.02g, 0.04g, 0.07g, 0.16g, 0.4g, 0.6g, 1g, 1.4g, 2g, 4g, 6g, 8g, 10g, 15g, with 0.008g being no neurosensory deficit. Although 28 persons completed the study, only 21 patients presented for their 3 month followup time, which was defined as with-in 15 days of 90th day after operation. Therefore, the denominator for this outcome is 21, for each intervention arm. The numerator is the number of Left or Right chin areas that exhibited less than "normal" sensation.
1 secondary outcome
Unfavorable Fracture
Time frame: This outcome occurs during the surgery. It was measured on the same day.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sohail Saghezchi, DDS, MD principal investigator
UC San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonopet ultrasonic saw and Reciprocating saw in people with Surgical Complication and Paresthesia, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. 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: finished, as of the sponsor's last update on 4 Jun 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 4 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Hypoesthesia Experienced at 3months (time frame: Within 15 days of exact 3 months post-operation). 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 4 Jun 2025.