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NCT05205616 · ClinicalTrials.gov registry record · NA
Trial of Bilateral Sagittal Split Osteotomy Induced Paresthesia Using Ultrasonic vs. Reciprocating Saw Instrumentation
A NA study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
NCT05205616: Completed NA study, sponsored by University of California, San Francisco.
NCT05205616 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05205616, a NA study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
Study 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.
Primary Outcome
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 foll
Interventions
- DEVICE Sonopet ultrasonic saw
- DEVICE Reciprocating saw
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2021-07-20 |
| Est. Completion | 2023-07-25 |
| Phase | NA |
What the finished NCT05205616 record still lists
NCT05205616 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Sonopet ultrasonic saw is the first listed.
NCT05205616 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05205616 about?
NCT05205616 is a clinical study titled "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 U...
What is the current status of trial NCT05205616?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2021-07-20. Estimated completion is 2023-07-25.
What interventions are being tested in trial NCT05205616?
The interventions under investigation include: Sonopet ultrasonic saw (DEVICE), Reciprocating saw (DEVICE).
Who is sponsoring clinical trial NCT05205616?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05205616's enrollment target sits among peer trials
32 1578th of 2000 higher than 409 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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