Impact of Different Instrument Modifications on Lateral Nasal Wall Osteotomy and Pterygomaxillary Separation in Le Fort I Surgery
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
1 other identifier
interventional
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2024
CompletedFirst Submitted
Initial submission to the registry
October 4, 2024
CompletedFirst Posted
Study publicly available on registry
October 8, 2024
CompletedOctober 8, 2024
October 1, 2024
3 months
October 4, 2024
October 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
lateral nasal wall fracture type
Class 1: Fracture at the osteotomy line Class 2: Fracture 2-4 mm above the osteotomy line Class 3: Fracture more than 4 mm above the osteotomy line
6 months
Secondary Outcomes (1)
pterygomaxillary junction fracture type
6 months
Study Arms (2)
Nievert osteotomy group
EXPERIMENTALlateral nasal wall osteotomy has been performed with single guided Nievert osteotome.
Blade osteotomy group
ACTIVE COMPARATORlateral nasal wall osteotomy has been performed with blade osteotome.
Interventions
Eligibility Criteria
You may qualify if:
- Patients requiring Le Fort I or bimaxillary surgery
- Patients who have not previously undergone Le Fort I or bimaxillary surgery (revision)
- Patients without cleft lip or palate
- Patients with no history of midface fractures or craniofacial trauma
You may not qualify if:
- Patients with cleft lip and/or palate requiring orthognathic surgery
- Patients with a history of trauma needing orthognathic surgery for malocclusion correction
- Patients who have previously undergone orthognathic surgery and require revision surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bezmialem Vakıf Universty
Istanbul, Fatih, 34093, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2024
First Posted
October 8, 2024
Study Start
May 1, 2024
Primary Completion
August 12, 2024
Study Completion
August 12, 2024
Last Updated
October 8, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share