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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-20

Study Completion Date

2023-07-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ultrasound-guided Bilateral Suprazygomatic Maxillary Nerve Block and Bimaxillary Osteotomy

NCT03913429

Dentofacial Deformities Regional Anesthesia Morbidity

COMPLETED NA

Assessment of Nerve Function After Mandible Surgery With a Modified Bilateral Sagittal Split Osteotomy Technique

NCT02634840

Neurosensory Function of Inferior Alveolar Nerve

COMPLETED NA

Pain Reduction in Maxillomandibular Surgery Using Maxillary and Mandibular Nerve Blocks

NCT05351151

Pain, Post Operative Regional Anesthesia

COMPLETED NA

Effects of Ultrasound-guided Maxillary Nerve Block Performed After Bimaxillary Osteotomy in Adult Patients

NCT06460051

Maxillary Diseases Pain, Postoperative Adult Patients Undergoing Bimaxillary Osteotomy

NOT_YET_RECRUITING NA

Evaluation of Use of Ultrasound for Greater Palatine Nerve Block and Inferior Alveolar Nerve Blocks: An Open Label Feasibility Study

NCT01870232

Greater Palatine Nerve Block Inferior Alveolar Nerve Block

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Patients and providers assessing postoperative nerve functioning are blinded to which side of the mandible received which intervention

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Reciprocating saw

The traditional surgical instrument used for cutting bilateral sagittal split osteotomies

Group Type PLACEBO_COMPARATOR

Reciprocating saw

Intervention Type DEVICE

See above description

Sonopet ultrasonic saw

This instrument is being compared to the reciprocating saw

Group Type ACTIVE_COMPARATOR

Sonopet ultrasonic saw

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sonopet ultrasonic saw

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

Intervention Type DEVICE

Reciprocating saw

See above description

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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".

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes