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

Study Overview
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Brief Summary
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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.

Official Title
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In-person Randomized Control Trial of the Incidence of Postoperative Hypoesthesia Among Bilateral Sagittal Split Osteotomy Patients Treated With Ultrasonic vs. Reciprocating Saw Instrumentation

Conditions
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Surgical Complication, Paresthesia, Fracture, Nerve Injury, Nerve Entrapments, Mandibular Nerve Injuries, Mandibular Hypoplasia, Mandibular Retrognathism, Mandibular Hyperplasia, Mandibular Prognathism

Intervention / Treatment
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* Device: Sonopet ultrasonic saw
* Device: Reciprocating saw


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A matched-pair (with-in person) RCT design will be used, wherein one mandibular side (right versus left) in each patient will be randomized to be treated with Sonopet ultrasonic device (with the remaining side being treated with reciprocating saw). Neurosensory impairment, as herein described, will be compared at various post-operative times for a total follow-up of 3 months for each patients. Patients and the researchers examining patients post-operatively will be blinded.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Reciprocating saw<br>The traditional surgical instrument used for cutting bilateral sagittal split osteotomies | Device: Reciprocating saw<br>* See above description<br>|
| Active Comparator: Sonopet ultrasonic saw<br>This instrument is being compared to the reciprocating saw | Device: Sonopet ultrasonic saw<br>* Ultrasonic saw to be used on a randomized side of the mandible, reciprocating saw will be used on other side<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative hypoesthesia | mandibular numbness in patients treated with reciprocating saw vs. ultrasonic saw | 3 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paresthesia, BSSO, Bilateral Saggital Split Osteotomy, Unfavorable split, Unfavorable fracture, Inferior Alveolar Nerve, Reciprocating Saw, Ultrasonic Saw, Pair matched, Randomized Control Trial