Trials / Completed
CompletedNCT05205616
Trial of Bilateral Sagittal Split Osteotomy Induced Paresthesia Using Ultrasonic vs. Reciprocating Saw Instrumentation
In-person Randomized Control Trial of the Incidence of Postoperative Hypoesthesia Among Bilateral Sagittal Split Osteotomy Patients Treated With Ultrasonic vs. Reciprocating Saw Instrumentation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- University of California, San Francisco · Academic / Other
- Sex
- All
- Age
- 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Surgical Complication
- Paresthesia
- Fracture
- Nerve Injury
- Nerve Entrapments
- Mandibular Nerve Injuries
- Mandibular Hypoplasia
- Mandibular Retrognathism
- Mandibular Hyperplasia
- Mandibular Prognathism
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sonopet ultrasonic saw | Ultrasonic saw to be used on a randomized side of the mandible, reciprocating saw will be used on other side |
| DEVICE | Reciprocating saw | See above description |
Timeline
- Start date
- 2021-07-20
- Primary completion
- 2023-07-25
- Completion
- 2023-07-25
- First posted
- 2022-01-25
- Last updated
- 2025-06-04
- Results posted
- 2025-06-04
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05205616. Inclusion in this directory is not an endorsement.