Mandibular Slotplates

Craniofacial Abnormalities Clinical Trial

Official title:

Mandibular Slotplates

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03679377
• Other study ID #: Mandi slot plates v 1.0
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: August 2019
• Source: Universitair Ziekenhuis Brussel
• Contact: Veerle Van Mossevelde, Datanurse
• Phone: +3224763134
• Email: veerle.vanmossevelde[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: February 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients undergoing single osteotomy BSSO surgery

Exclusion Criteria:

• Concomitant surgeries at the same time.

Related Conditions & MeSH terms

• Craniofacial Abnormalities

Intervention

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.

Locations

Country	Name	City	State
Belgium	universitair Ziekenhuis Brussel	Jette	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasebility of the slotprinciple	yes or no	during surgery
Primary	Inclination of the screws	Useful yes or no	during surgery