NCT03679377

Mandibular Slotplates

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 12 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Craniofacial Abnormalities

Interventions

Type	Name	Description
DEVICE	Mandibular slotplate	Mandibular slotplates are placed during the osteosynthesis phase of the BSSO surgery. After testing of the plates they are removed and the osteotomy is fixated with three bicortical screws.

Timeline

• Start date: 2018-11-07
• Primary completion: 2019-12-31
• Completion: 2020-02-01
• First posted: 2018-09-20
• Last updated: 2019-08-28

Locations

1 site across 1 country: Belgium