Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629935
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Impact of Different Instrument Modifications on Lateral Nasal Wall Osteotomy and Pterygomaxillary Separation in Le Fort I Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessment of How Different Instrument Modifications in Le Fort I Surgery Influence the Osteotomy of the Lateral Nasal Wall With a Focus on the Level of Fractures and the Separation Pattern of the Pterygomaxillary Junction
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to investigate the effect of different instrument modifications on the customized osteotomy of the lateral nasal wall in Le Fort I surgery focusing on the level of lateral nasal wall fractures and the separation pattern of the pterygomaxillary junction
The primary hypothesis is blade osteotome is useful and facilitate the fracture line in ideal level both for lateral nasal wall and the pterygomaxillary junction
The primary hypothesis is blade osteotome is useful and facilitate the fracture line in ideal level both for lateral nasal wall and the pterygomaxillary junction
Detailed Description:
While there are numerous studies in the literature evaluating various parameters related to maxillary down-fracture in Le Fort I osteotomy studies specifically focused on lateral nasal osteotomy are very rare There is no study in the literature has addressed customized lateral nasal osteotomy using different instruments In our study the lateral nasal wall osteotomy will be performed 2 mm shorter than the measured descending palatine ater distance in the axial computer tomography plane One group n23 will use the routinely employed Nievert osteotome single guided osteotome while the other group n23 will use a blade osteotome no guided tip This study aims to evaluate parameters such as the fracture pattern of the lateral nasal walls and the separation pattern of the pterygomaxillary junction by using different instrument modifications for lateral nasal wall osteotomy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None