Mandibular Slotplates
- Conditions
- Craniofacial Abnormalities
- Interventions
- Device: Mandibular slotplate
- Registration Number
- NCT03679377
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- Brief Summary
A new osteosynthesis system for orthognathic surgery was proposed.This system allows small intra-operative adjustments of the bone fragments during the osteosynthesis phase of the operation (also known as the slot principle). Another possible advantage are the slant screw holes with chamfered ridges allowing easy placements of the screws via the small incision wound without undercuts in between the plate and the screwheads.
- Detailed Description
Initial slotplates were developed for Le Fort I osteotomies, zygoma 'sandwich 'osteotomies and genioplasties. Those plates allowed for the slot principle to be performed during orthognathic surgery. Mandibular slotplates for bilateral sagittal split osteotomy (BSSO) were recently designed. The aim of the study is to evaluate their clinical usefulness and the applicability of the slot principle with these plates in BSSO.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 9
• Patients undergoing single osteotomy BSSO surgery
• Concomitant surgeries at the same time.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mandibular slotplate Mandibular slotplate Mandibular slotplates are placed during BSSO surgery and their clinical usefullness is tested. Afterwards the plates are removed and the osteotomy is fixated by three bicortical screws.
- Primary Outcome Measures
Name Time Method Feasebility of the slotprinciple during surgery yes or no
Inclination of the screws during surgery Useful yes or no
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
universitair Ziekenhuis Brussel
🇧🇪Jette, Vlaams Brabant, Belgium