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

Not Applicable

Completed

• Conditions: Paresthesia; Nerve Injury; Fracture; Mandibular Prognathism; Nerve Entrapments; Mandibular Nerve Injuries; Mandibular Hyperplasia; Mandibular Hypoplasia; Surgical Complication; Mandibular Retrognathism
• Interventions: Device: Sonopet ultrasonic saw; Device: Reciprocating saw

• Registration Number: NCT05205616
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-07-20
• Study First Submitted: 2022-01-11
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-25
• Primary Completion: 2023-07-25
• Study Completion: 2023-07-25
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

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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".

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sonopet ultrasonic saw	Sonopet ultrasonic saw	This instrument is being compared to the reciprocating saw
Reciprocating saw	Reciprocating saw	The traditional surgical instrument used for cutting bilateral sagittal split osteotomies

Primary Outcome Measures

Name	Time	Method
Postoperative hypoesthesia	3 months postoperatively	mandibular numbness in patients treated with reciprocating saw vs. ultrasonic saw

Trial Locations

Locations (2)

University of California, San Francisco Medical Center; 🇺🇸 San Francisco, California, United States

UCSF Benioff Children's Hospital; 🇺🇸 San Francisco, California, United States