Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04706182
Status:
RECRUITING
Last Update Posted:
2021-01-12
First Post:
2021-01-09
Brief Title:
Platelet-rich Fibrin and Grooving for Sagittal Split Osteotomy
Sponsor:
Jesse Han
Organization:
University of Washington
Study Overview
Official Title:
Neurosensory Outcomes With Platelet-Rich Fibrin and Proximal Segment Grooving in Sagittal Split Osteotomy A Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sagittal split osteotomy SSO is a common operation done to move the mandible to correct dentofacial deformities and obstructive sleep apnea OSA Inferior alveolar nerve IAN injury and associated paresthesia is a well-known negative outcome following SSO causing temporary or sometimes permanent numbness in the chin andor lip There are limited methods to decrease the occurrence and duration of neurosensory dysfunction Recent research has shown that platelet-rich fibrin PRF aids neurosensory recovery after SSO Another method to minimize nerve injury is proximal segment grooving PSG to create space for the nerve to rest This grooving method has never been formerly reported The purpose of this study is to answer the following question Among patients undergoing bilateral sagittal split osteotomy BSSO for dentofacial deformity or OSA do those who receive PRF with or without PSG compared to those who do not have shorter times to functional sensory recovery FSR of the IAN The null hypothesis is that there is no difference among 4 treatment groups and neurosensory outcomes The specific aims of this proposal are to 1 enroll and randomize subjects who will undergo BSSO for correction of dentofacial deformity or OSA into 4 different treatment groups PSG with PRF PSG alone PRF alone neither PSG or PRF 2 measure objective and subjective post-operative nerve function at fixed intervals post-operatively for up to 1 year 3 compare differences in neurosensory outcomes among treatment groups and 4 identify other variables that might be associated with differences in neurosensory outcomes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None