Mandibular Slotplates

NCT ID: NCT03679377

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-07

Study Completion Date

2020-02-01

Brief Summary

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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

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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

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Craniofacial Abnormalities

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Mandibular slotplates are placed during the osteosynthesis phase of the BSSO surgery. After clinical testing during the surgery the plates are removed and the osteotomy is fixated with bicortical screws.
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mandibular slotplate

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

• Patients undergoing single osteotomy BSSO surgery

Exclusion Criteria

• Concomitant surgeries at the same time.
Minimum Eligible Age

12 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Veerle Van Mossevelde

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brandaan Zigterman, MD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Maurice Mommaerts, Prof Mult

Role: STUDY_DIRECTOR

Universitair Ziekenhuis Brussel

Locations

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universitair Ziekenhuis Brussel

Jette, Vlaams Brabant, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Veerle Van Mossevelde, Datanurse

Role: CONTACT

+3224763134

Annelies De Cock, Datanurse

Role: CONTACT

+3224779906

Facility Contacts

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Veerle Van Mossevelde

Role: primary

+3224763134

Other Identifiers

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Mandi slot plates v 1.0

Identifier Type: -

Identifier Source: org_study_id

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