ClinicalTrials.gg
Status unknownNCT03679377Updated Aug 28, 2019

Mandibular Slotplates

An interventional study of Mandibular slotplate in Craniofacial Abnormalities, sponsored by Universitair Ziekenhuis Brussel. Status unknown at 1 site in Belgium. Open to participants aged 12 Years to 50 Years. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Device feasibility

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
12 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Craniofacial Abnormalities

Keywords

  • Orthognathic surgical procedures
  • Osteosynthesis
03

In context

Craniofacial Abnormalities

22 studies on the registry are indexed under Craniofacial Abnormalities; 4 are open to participants now.

Browse Craniofacial Abnormalities studies →

Lead sponsor

Universitair Ziekenhuis Brussel is the lead sponsor of 374 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing single osteotomy BSSO surgery

Exclusion criteria

Exclusion Criteria:

  • Concomitant surgeries at the same time.
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (estimated)

Study arms

  • Experimental
    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.

    Device: Mandibular slotplate

Interventions

  • DeviceMandibular 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.

06

What researchers measure

Primary outcomes

  1. Feasebility of the slotprinciple

    yes or no

    Time frame: during surgery

  2. Inclination of the screws

    Useful yes or no

    Time frame: during surgery

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2018 (actual). Primary completion is estimated for Dec 2019, 13 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2018
First posted
Sep 20, 2018
StartActual
Nov 7, 2018
Primary completionEst.
Dec 31, 2019
CompletionEst.
Feb 1, 2020
Last update
Aug 28, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03679377
Responsible party
Veerle Van Mossevelde (Director, Universitair Ziekenhuis Brussel) — Principal investigator
First posted
Sep 20, 2018
Start date
Nov 7, 2018
Primary completion
Dec 31, 2019 (estimated)
Completion
Feb 1, 2020 (estimated)
Last update
Aug 28, 2019

Study contacts

Veerle Van Mossevelde, Datanurse
Contact
veerle.vanmossevelde@uzbrussel.be
+3224763134
Annelies De Cock, Datanurse
Contact
annelies.decock@uzbrussel.be
+3224779906
Brandaan Zigterman, MD
principal investigator · Universitair Ziekenhuis Brussel
Maurice Mommaerts, Prof Mult
study director · Universitair Ziekenhuis Brussel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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