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

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ClinicalTrials.gov Identifier: NCT05205616
Recruitment Status : Enrolling by invitation
First Posted : January 25, 2022
Last Update Posted : October 17, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Surgical Complication Paresthesia Fracture Nerve Injury Nerve Entrapments Mandibular Nerve Injuries Mandibular Hypoplasia Mandibular Retrognathism Mandibular Hyperplasia Mandibular Prognathism Device: Sonopet ultrasonic saw Device: Reciprocating saw Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Patients and providers assessing postoperative nerve functioning are blinded to which side of the mandible received which intervention
Primary Purpose: Supportive Care
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
Actual Study Start Date : July 20, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023


Arm Intervention/treatment
Placebo Comparator: Reciprocating saw
The traditional surgical instrument used for cutting bilateral sagittal split osteotomies
Device: Reciprocating saw
See above description

Active Comparator: Sonopet ultrasonic saw
This instrument is being compared to the reciprocating saw
Device: Sonopet ultrasonic saw
Ultrasonic saw to be used on a randomized side of the mandible, reciprocating saw will be used on other side




Primary Outcome Measures :
  1. Postoperative hypoesthesia [ Time Frame: 3 months postoperatively ]
    mandibular numbness in patients treated with reciprocating saw vs. ultrasonic saw



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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".

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05205616


Locations
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United States, California
University of California, San Francisco Medical Center
San Francisco, California, United States, 94143
UCSF Benioff Children's Hospital
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Sohail Saghezchi, DDS, MD UC San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05205616    
Other Study ID Numbers: 21-33674
First Posted: January 25, 2022    Key Record Dates
Last Update Posted: October 17, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of California, San Francisco:
Paresthesia
BSSO
Bilateral Saggital Split Osteotomy
Unfavorable split
Unfavorable fracture
Inferior Alveolar Nerve
Reciprocating Saw
Ultrasonic Saw
Pair matched
Randomized Control Trial
Additional relevant MeSH terms:
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Retrognathia
Prognathism
Micrognathism
Malocclusion, Angle Class III
Mandibular Nerve Injuries
Nerve Compression Syndromes
Paresthesia
Hyperplasia
Wounds and Injuries
Pathologic Processes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mandibular Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities
Malocclusion
Tooth Diseases
Trigeminal Nerve Injuries
Trigeminal Nerve Diseases