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

NCT05205616 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-06-04

Study results available
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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.

Conditions

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

Interventions

DEVICE

Sonopet ultrasonic saw

Ultrasonic saw to be used on a randomized side of the mandible, reciprocating saw will be used on other side

DEVICE

Reciprocating saw

See above description

Sponsors & Collaborators

Principal Investigators

  • Sohail Saghezchi, DDS, MD · UC San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-20
Primary Completion
2023-07-25
Completion
2023-07-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05205616 on ClinicalTrials.gov