Trial of Bilateral Sagittal Split Osteotomy Induced Paresthesia Using Ultrasonic vs. Reciprocating Saw Instrumentation
Primary Purpose
Surgical Complication, Paresthesia, Fracture
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sonopet ultrasonic saw
Reciprocating saw
Sponsored by
About this trial
This is an interventional supportive care trial for Surgical Complication focused on measuring Paresthesia, BSSO, Bilateral Saggital Split Osteotomy, Unfavorable split, Unfavorable fracture, Inferior Alveolar Nerve, Reciprocating Saw, Ultrasonic Saw, Pair matched, Randomized Control Trial
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".
Sites / Locations
- University of California, San Francisco Medical Center
- UCSF Benioff Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Reciprocating saw
Sonopet ultrasonic saw
Arm Description
The traditional surgical instrument used for cutting bilateral sagittal split osteotomies
This instrument is being compared to the reciprocating saw
Outcomes
Primary Outcome Measures
Postoperative hypoesthesia
mandibular numbness in patients treated with reciprocating saw vs. ultrasonic saw
Secondary Outcome Measures
Full Information
NCT ID
NCT05205616
First Posted
January 11, 2022
Last Updated
September 12, 2023
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT05205616
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 20, 2021 (Actual)
Primary Completion Date
July 25, 2023 (Actual)
Study Completion Date
July 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
Patients and providers assessing postoperative nerve functioning are blinded to which side of the mandible received which intervention
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reciprocating saw
Arm Type
Placebo Comparator
Arm Description
The traditional surgical instrument used for cutting bilateral sagittal split osteotomies
Arm Title
Sonopet ultrasonic saw
Arm Type
Active Comparator
Arm Description
This instrument is being compared to the reciprocating saw
Intervention Type
Device
Intervention Name(s)
Sonopet ultrasonic saw
Intervention Description
Ultrasonic saw to be used on a randomized side of the mandible, reciprocating saw will be used on other side
Intervention Type
Device
Intervention Name(s)
Reciprocating saw
Intervention Description
See above description
Primary Outcome Measure Information:
Title
Postoperative hypoesthesia
Description
mandibular numbness in patients treated with reciprocating saw vs. ultrasonic saw
Time Frame
3 months postoperatively
10. Eligibility
Sex
All
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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".
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sohail Saghezchi, DDS, MD
Organizational Affiliation
UC San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
UCSF Benioff Children's Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Trial of Bilateral Sagittal Split Osteotomy Induced Paresthesia Using Ultrasonic vs. Reciprocating Saw Instrumentation
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