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

Fracture Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05205616
• Other study ID #: 21-33674
• Status: Completed
• Phase: N/A
• Start date: July 20, 2021
• Est. completion date: July 25, 2023

Study information

• Verified date: September 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 25, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 45 Years

Eligibility

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".

Related Conditions & MeSH terms

• Fracture
• Hyperplasia
• Malocclusion, Angle Class III
• Mandibular Hypoplasia
• Mandibular Prognathism
• Mandibular Retrognathism
• Micrognathism
• Nerve Compression Syndromes
• Nerve Injury
• Paresthesia
• Prognathism
• Retrognathia
• Surgical Complication
• Wounds and Injuries

Intervention

Device:
• Sonopet ultrasonic saw
Ultrasonic saw to be used on a randomized side of the mandible, reciprocating saw will be used on other side
• Reciprocating saw
See above description

Locations

Country	Name	City	State
United States	UCSF Benioff Children's Hospital	San Francisco	California
United States	University of California, San Francisco Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative hypoesthesia	mandibular numbness in patients treated with reciprocating saw vs. ultrasonic saw	3 months postoperatively