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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05205616
Other study ID # 21-33674
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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".

Study Design


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
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