Mandibular Slotplates

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03679377

Enrollment

Registered

2018-09-20

Start date

2018-11-07

Completion date

2020-02-01

Last updated

2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniofacial Abnormalities

Keywords

Orthognathic surgical procedures, Osteosynthesis

Brief 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.

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Intervention model description

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.

Eligibility

Sex/Gender

ALL

Age

12 Years to 50 Years

Healthy volunteers

Inclusion criteria

• Patients undergoing single osteotomy BSSO surgery

Exclusion criteria

• Concomitant surgeries at the same time.

Design outcomes

Primary

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

Countries

Belgium

Contacts

Primary ContactVeerle Van Mossevelde, Datanurse

veerle.vanmossevelde@uzbrussel.be+3224763134

Backup ContactAnnelies De Cock, Datanurse

annelies.decock@uzbrussel.be+3224779906

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026