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

NCT05205616 | Completed Results FDA Device

• 1 other identifier: 21-33674
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Postoperative Hypoesthesia Experienced at 3months

  Count of patient mandibles who exhibited \*\*any\*\* hypoesthesia at 3months post-operation (i.e. VFH does not equal 0.008g). VFH filaments measure the minimum weight which a dermatome in question can sense. In this study, the measurements were designed to have the following range: 0.008g, 0.02g, 0.04g, 0.07g, 0.16g, 0.4g, 0.6g, 1g, 1.4g, 2g, 4g, 6g, 8g, 10g, 15g, with 0.008g being no neurosensory deficit. Although 28 persons completed the study, only 21 patients presented for their 3 month followup time, which was defined as with-in 15 days of 90th day after operation. Therefore, the denominator for this outcome is 21, for each intervention arm. The numerator is the number of Left or Right chin areas that exhibited less than "normal" sensation.

  Within 15 days of exact 3 months post-operation

Secondary Outcomes (1)

• Unfavorable Fracture

  This outcome occurs during the surgery. It was measured on the same day.

Study Arms (2)

Reciprocating saw

PLACEBO COMPARATOR

The traditional surgical instrument used for cutting bilateral sagittal split osteotomies

Device: Reciprocating saw

Sonopet ultrasonic saw

ACTIVE COMPARATOR

This instrument is being compared to the reciprocating saw

Device: Sonopet ultrasonic saw

Interventions

Sonopet ultrasonic saw DEVICE

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

Sonopet ultrasonic saw

Reciprocating saw DEVICE

See above description

Reciprocating saw

Eligibility Criteria

• Age: Up to 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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".

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (2)

University of California, San Francisco Medical Center

San Francisco, California, 94143, United States

Location

UCSF Benioff Children's Hospital

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Paresthesia; Fractures, Bone; Nerve Compression Syndromes; Mandibular Nerve Injuries; Micrognathism; Malocclusion, Angle Class III

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases; Trigeminal Nerve Injuries; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Injuries; Cranial Nerve Diseases; Craniocerebral Trauma; Trauma, Nervous System; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Malocclusion; Tooth Diseases

Limitations and Caveats

Given the relatively few secondary outcome occurrences, unfavorable mandibular fractures, which occurred in 2/28 in the reciprocating saw arm and 0/28 in the ultrasonic saw arm, it is not possible to meaningfully interpret the findings for the secondary outcome.

Results Point of Contact

• Title: Sepehr Hashemi, DMD
• Organization: University of Califronia, San Francisco

sepehr.hashemi@ucsf.edu

4133674736

Study Officials

• Sohail Saghezchi, DDS, MD

  UC San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and providers assessing postoperative nerve functioning are blinded to which side of the mandible received which intervention
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 25, 2022
• Study Start: July 20, 2021
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: June 4, 2025
• Results First Posted: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)