Craniofacial AbnormalitiesNCT03679377
Mandibular Slotplates
A study testing Mandibular slotplate in people with Craniofacial Abnormalities, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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). Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Craniofacial Abnormalities
- What is being tested?
- Mandibular slotplate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Nov 2018to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients undergoing single osteotomy BSSO surgery
Who cannot join
- Concomitant surgeries at the same time.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
universitair Ziekenhuis Brussel
Jette, Vlaams Brabant, 1090
Veerle Van Mossevelde, +3224763134, veerle.vanmossevelde@uzbrussel.be
About this study
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.
- Conditions
- Craniofacial Abnormalities
- Being tested
- Mandibular slotplate
- Keywords
- Orthognathic surgical procedures, Osteosynthesis
- Medical subject headings
- Craniofacial Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular slotplateDevice
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 group | Role | What they receive |
|---|---|---|
| Mandibular slotplate | Experimental | 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. Receives: Device: Mandibular slotplate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasebility of the slotprinciple
yes or no
Measured: during surgery
Inclination of the screws
Useful yes or no
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start7 Nov 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniofacial AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veerle Van Mossevelde, Universitair Ziekenhuis Brussel
- Investigators
- Brandaan Zigterman, MD, Principal investigator, Universitair Ziekenhuis BrusselMaurice Mommaerts, Prof Mult, Study director, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679377
- Sponsor's protocol ID
- Mandi slot plates v 1.0
- Status last verified
- Aug 2019
- First submitted
- 19 Sep 2018
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mandibular Slotplates
- ClinicalTrials.gov ID
- NCT03679377
- Acronym / sponsor ID
- Mandi slot plates v 1.0
- Conditions
- Craniofacial Abnormalities
- Keywords
- Orthognathic surgical procedures, Osteosynthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 20 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mandibular slotplate | Experimental | Device: Mandibular slotplateMandibular 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. |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients undergoing single osteotomy BSSO surgery
Key exclusion criteria (1 listed)
- Concomitant surgeries at the same time.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandibular slotplateMandibular 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. | Device | Mandibular slotplate |
Primary outcome
Feasebility of the slotprinciple
Time frame: during surgery
yes or no
Inclination of the screws
Time frame: during surgery
Useful yes or no
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandaan Zigterman, MD principal investigator
Universitair Ziekenhuis Brussel
Maurice Mommaerts, Prof Mult study director
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular slotplate in people with Craniofacial Abnormalities, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veerle Van Mossevelde, Datanurse (+3224763134, veerle.vanmossevelde@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasebility of the slotprinciple (time frame: during surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.