Trial Outcomes & Findings for Trial of Bilateral Sagittal Split Osteotomy Induced Paresthesia Using Ultrasonic vs. Reciprocating Saw Instrumentation (NCT NCT05205616)

NCT ID: NCT05205616

Last Updated: 2025-06-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

32 participants

Primary outcome timeframe

Within 15 days of exact 3 months post-operation

Results posted on

2025-06-04

Participant Flow

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.

Unit of analysis: Mandibular Rami

Participant milestones

Participant milestones
Measure	Reciprocating Saw The traditional surgical instrument used for cutting bilateral sagittal split osteotomies Reciprocating saw: See above description	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
Overall Study STARTED	32 32	32 32
Overall Study COMPLETED	28 28	28 28
Overall Study NOT COMPLETED	4 4	4 4

Reasons for withdrawal

Reasons for withdrawal
Measure	Reciprocating Saw The traditional surgical instrument used for cutting bilateral sagittal split osteotomies Reciprocating saw: See above description	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
Overall Study Lost to Follow-up	4	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Reciprocating Saw n=28 Mandibular Rami The traditional surgical instrument used for cutting bilateral sagittal split osteotomies Reciprocating saw: See above description	Sonopet Ultrasonic Saw n=28 Mandibular Rami 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	Total n=56 Mandibular Rami Total of all reporting groups
Age, Continuous	25.95 years STANDARD_DEVIATION 9.8 • n=5 Participants	25.95 years STANDARD_DEVIATION 9.8 • n=7 Participants	25.95 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Latinx	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Asian	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Normal Baseline VFH Score (Lightest VFH Filament sensed has a weight of 0.008g)	23 Mandibular Rami n=28 Mandibular Rami	22 Mandibular Rami n=28 Mandibular Rami	45 Mandibular Rami n=56 Mandibular Rami

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Reciprocating Saw n=21 Left or Right Chin Area The traditional surgical instrument used for cutting bilateral sagittal split osteotomies Reciprocating saw: See above description	Sonopet Ultrasonic Saw n=21 Left or Right Chin Area 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
Postoperative Hypoesthesia Experienced at 3months	8 Left or Right Chin Area	3 Left or Right Chin Area

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Reciprocating Saw n=28 Mandibular rami The traditional surgical instrument used for cutting bilateral sagittal split osteotomies Reciprocating saw: See above description	Sonopet Ultrasonic Saw n=28 Mandibular rami 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
Unfavorable Fracture	2 Mandibular rami	0 Mandibular rami

Adverse Events

Reciprocating Saw

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Sonopet Ultrasonic Saw

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Reciprocating Saw n=28 participants at risk The traditional surgical instrument used for cutting bilateral sagittal split osteotomies Reciprocating saw: See above description	Sonopet Ultrasonic Saw n=28 participants at risk 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
Surgical and medical procedures Transaction of Inferior Alveolar Nerve (IAN), which provides sensation to the chin area	14.3% 4/28 • Number of events 4 • At a minimum each participant who was not lost to follow up was followed for three months (defined as 85 - 115 days) after their operation. However, patients were followed as long as they return for assessment of their orthognathic surgery. The follow up of participants who completed the study ranged from 85 days to 419 days.	3.6% 1/28 • Number of events 1 • At a minimum each participant who was not lost to follow up was followed for three months (defined as 85 - 115 days) after their operation. However, patients were followed as long as they return for assessment of their orthognathic surgery. The follow up of participants who completed the study ranged from 85 days to 419 days.

Additional Information

Sepehr Hashemi, DMD

University of Califronia, San Francisco

Phone: 4133674736

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place