Trial of Bilateral Sagittal Split Osteotomy Induced Paresthesia Using Ultrasonic vs. Reciprocating Saw Instrumentation

University of California San Francisco (UCSF)

Status

Completed

Conditions

Paresthesia

Mandibular Retrognathism

Mandibular Prognathism

Fracture

Nerve Entrapments

Mandibular Hypoplasia

Surgical Complication

Mandibular Nerve Injuries

Mandibular Hyperplasia

Nerve Injury

Treatments

Device: Sonopet ultrasonic saw

Device: Reciprocating saw

Study type

Interventional

Funder types

Other

Identifiers

NCT05205616

21-33674

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

All

Ages

Under 45 years old

Volunteers

Accepts Healthy Volunteers

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".