Fracture, Mandibular Hyperplasia, Mandibular Hypoplasia, Mandibular Nerve Injuries, Mandibular Prognathism, Mandibular Retrognathism, Nerve Entrapments, Nerve Injury, Paresthesia, Surgical Complication
Conditions
Keywords
Paresthesia, BSSO, Bilateral Saggital Split Osteotomy, Unfavorable split, Unfavorable fracture, Inferior Alveolar Nerve, Reciprocating Saw, Ultrasonic Saw, Pair matched, Randomized Control Trial
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.
Interventions
DEVICESonopet ultrasonic saw
Ultrasonic saw to be used on a randomized side of the mandible, reciprocating saw will be used on other side
DEVICEReciprocating saw
See above description
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients and providers assessing postoperative nerve functioning are blinded to which side of the mandible received which intervention
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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Hypoesthesia Experienced at 3months | 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
| Measure | Time frame | Description |
|---|---|---|
| Unfavorable Fracture | 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. |
Countries
United States
Participant flow
Recruitment details
Please note that since this is a pair-matched split-mouth study, where each participant was in both arms of the study since their left and right mandibles were the units receiving the different interventions in the study. Therefore, the total persons enrolled was 32 persons, while the total mandibles enrolled was 64.
Participants by arm
| Arm | Count |
|---|---|
| Reciprocating Saw The traditional surgical instrument used for cutting bilateral sagittal split osteotomies
Reciprocating saw: See above description | 28 |
| Reciprocating Saw The traditional surgical instrument used for cutting bilateral sagittal split osteotomies
Reciprocating saw: See above description | 28 |
| Sonopet Ultrasonic Saw This instrument is being compared to the reciprocating saw
Sonopet ultrasonic saw: Ultrasonic saw to be used on a randomized side of the mandible, reciprocating saw will be used on other side | 28 |
| Sonopet Ultrasonic Saw This instrument is being compared to the reciprocating saw
Sonopet ultrasonic saw: Ultrasonic saw to be used on a randomized side of the mandible, reciprocating saw will be used on other side | 28 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 4 |
Baseline characteristics
| Characteristic | Reciprocating Saw | Sonopet Ultrasonic Saw | Total |
|---|---|---|---|
| Age, Continuous | 25.95 years STANDARD_DEVIATION 9.8 | 25.95 years STANDARD_DEVIATION 9.8 | 25.95 years STANDARD_DEVIATION 9.8 |
| Normal Baseline VFH Score (Lightest VFH Filament sensed has a weight of 0.008g) | 23 Mandibular Rami | 22 Mandibular Rami | 45 Mandibular Rami |
| Race/Ethnicity, Customized African American | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 6 Participants | 12 Participants |
| Race/Ethnicity, Customized Caucasian | 13 Participants | 13 Participants | 26 Participants |
| Race/Ethnicity, Customized Latinx | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 4 / 28 | 1 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
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.
Time frame: Within 15 days of exact 3 months post-operation
Population: 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.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Reciprocating Saw | Postoperative Hypoesthesia Experienced at 3months | 8 Left or Right Chin Area |
| Sonopet Ultrasonic Saw | Postoperative Hypoesthesia Experienced at 3months | 3 Left or Right Chin Area |
Secondary
Unfavorable Fracture
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.
Time frame: This outcome occurs during the surgery. It was measured on the same day.
Population: Each study participant was enrolled in both study arms, but only one of each person's two mandible was randomized to each study arm.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Reciprocating Saw | Unfavorable Fracture | 2 Mandibular rami |
| Sonopet Ultrasonic Saw | Unfavorable Fracture | 0 Mandibular rami |