N/A
N=64
Trial of Bilateral Sagittal Split Osteotomy Induced Paresthesia Using Ultrasonic vs. Reciprocating Saw Instrumentation
Surgical Complication · Paresthesia · Fracture · Nerve Injury · Nerve Entrapments
Bottom Line
View on ClinicalTrials.gov: NCT05205616 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Postoperative Hypoesthesia Experienced at 3months — 8; 3 Left or Right Chin Area
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sonopet ultrasonic saw (Device); Reciprocating saw (Device)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Hypoesthesia Experienced at 3months |
8; 3 | — |
| SECONDARY Unfavorable Fracture |
2; 0 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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".
Data sourced from ClinicalTrials.gov (NCT05205616). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.