Mandibular Slotplates

Universitair Ziekenhuis Brussel

Status: Unknown

Conditions: Craniofacial Abnormalities

Treatments: Device: Mandibular slotplate

Study type: Interventional

Funder types: Other

Identifiers

NCT03679377

Mandi slot plates v 1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 estimated patients

Sex: All

Ages: 12 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing single osteotomy BSSO surgery

Exclusion criteria

• Concomitant surgeries at the same time.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Mandibular slotplate

Experimental group

Description:

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.

Treatment:

Device: Mandibular slotplate