Clinical trial NCT05205616: Trial of Bilateral Sagittal Split Osteotomy Induced Paresthesia Using Ultrasonic vs. Reciprocating Saw Instrumentation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Complication
Paresthesia
Fracture
Nerve Injury
Nerve Entrapments
Mandibular Nerve Injuries
Mandibular Hypoplasia
Mandibular Retrognathism
Mandibular Hyperplasia
Mandibular Prognathism
Keywords: Paresthesia
BSSO
Bilateral Saggital Split Osteotomy
Unfavorable split
Unfavorable fracture
Inferior Alveolar Nerve
Reciprocating Saw
Ultrasonic Saw
Pair matched
Randomized Control Trial
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 32
Sex: ALL
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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".

Primary outcomes:
measure: Postoperative Hypoesthesia Experienced at 3months
timeFrame: Within 15 days of exact 3 months post-operation
Secondary outcomes:
measure: Unfavorable Fracture
timeFrame: This outcome occurs during the surgery. It was measured on the same day.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco Medical Center
state: California
city: San Francisco
country: United States
facility: UCSF Benioff Children's Hospital
state: California
Study officials:
affiliation: UC San Francisco
name: Sohail Saghezchi, DDS, MD
role: PRINCIPAL_INVESTIGATOR
References: