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Completed

NCT Number: NCT05205616

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

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.

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Key information

Conditions

Surgical Complication Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cranial Nerve Diseases Cranial Nerve Injuries Craniocerebral Trauma Craniofacial Abnormalities Facial Nerve Diseases Facial Neuralgia Fracture Fractures, Bone Jaw Abnormalities Jaw Diseases Malocclusion Malocclusion, Angle Class III Mandibular Hyperplasia Mandibular Hypoplasia Mandibular Nerve Injuries Mandibular Prognathism Mandibular Retrognathism Maxillofacial Abnormalities Micrognathism Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Nerve Compression Syndromes Nerve Entrapments Nerve Injury Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Paresthesia Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Sensation Disorders Signs and Symptoms Somatosensory Disorders Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Diseases Trauma, Nervous System Trigeminal Nerve Diseases Trigeminal Nerve Injuries Wounds and Injuries

Age range

Up to 45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Benioff Children's Hospital, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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".

Treatment and study plan

Sonopet ultrasonic saw

Device

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

Reciprocating saw

Device

See above description

Primary outcomes

  1. Postoperative Hypoesthesia Experienced at 3months

    Time frame: Within 15 days of exact 3 months post-operation

    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.

Secondary outcomes

  1. Unfavorable Fracture

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

    When a saggital split osteotomy is performed, a controlled fracture of the mandibular ramus is induced which follows an exact intended path of fracture. An unfavorable fracture is one that does not follow this exact path of fracture, and needs to be surgically mended. An unfavorable fracture is associated with poorer post-operative recovery.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 25, 2022
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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