Trial of Bilateral Sagittal Split Osteotomy Induced Paresthesia Using Ultrasonic vs. Reciprocating Saw Instrumentation
Completed · Not applicable
Conditions studied: Surgical Complication, Paresthesia, Fracture, Nerve Injury, Nerve Entrapments, Mandibular Nerve Injuries, Mandibular Hypoplasia, Mandibular Retrognathism, Mandibular Hyperplasia, Mandibular Prognathism
In brief
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.
Key facts
- Study ID
- NCT05205616
- Run by
- University of California, San Francisco
- People needed
- 32
- Starts
- 2021-07-20
- Expected to finish
- 2023-07-25
- Last updated by the study team
- 2025-06-04
Who can join
Age: any, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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".
Where it is running
- University of California, San Francisco Medical Center — San Francisco, California, United States
- UCSF Benioff Children's Hospital — San Francisco, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.