Cleft Palate ChildrenVIR-CLEFTNCT03994679
Feasibility and Performance of Virtual Software for Virtual Bone Graft Planning in Cleft Patients
An observational study of Cleft Palate Children, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial summary
Objective: The investigators aim to compare the licensed Brainlab Iplan® software, considered the gold standard, to the 3D slicers and Blender freeware for the segmentation of the unilateral cleft defect, as well as the creation of individual 3D template for development of the bone graft. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Cleft Palate Children
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Nov 2018to 31 Dec 2020
- Phase
- Observational
- 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 7 to 12 years
- All sexes
- Child
Study population: Patients presenting at the division of maxillofacial surgery at the AZ Sint-Jan Brugge-Oostende av (Belgium) or the 1st department of pediatrics at the USemmelweis (Hungary) for bone graft surgery of the unilateral cleft receive a complete routine work-up, including a cone-beam CT (CBCT).
Who may be able to join
- Patients with a unilateral cleft
- Patients of all genders
- Patients aged 7-12 years old
- Patients should have presented themselves at the division of maxillofacial surgery, at the participating hospital centers, for bone graft surgery
- Patients should have received standardized cone-beam computed tomography (CBCT) image acquisition as part of routine work-up, and all original DICOM files should be present
- Preoperative 3D virtual planning should be performed by the same investigator per center with both the licensed software and the freeware
Who cannot join
- All patients that do not fit the abovementioned description
- Patients with previous bone graft surgery
- Patients with posttraumatic deformity
- Patients with preprosthetic indication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Performance of Brainlab Iplan Software, in Comparison to Freeware for Virtual Bone Graft Planning in Unilateral Cleft Patients: a Retrospective, Pilot Study
Objective: The investigators aim to compare the licensed Brainlab Iplan® software, considered the gold standard, to the 3D slicers and Blender freeware for the segmentation of the unilateral cleft defect, as well as the creation of individual 3D template for development of the bone graft.
Study design Retrospective, pilot study Patients presenting at the division of maxillofacial surgery at the AZ Sint-Jan Brugge-Oostende av (Belgium) or the 1st department of pediatrics at the USemmelweis (Hungary) for bone graft surgery of the unilateral cleft receive a complete routine work-up, including a cone-beam CT (CBCT). A single surgeon will run all the virtual planning steps with both the licensed software and the freeware. Timing of the four major steps will be measured with a digital chronometer (http://www.online-stopwatch.com/download-stopwatch/).
Read more
Ten children, 5 Belgian patients and 5 Hungarian patients, that already had a work-up and surgery for a unilateral cleft requiring a bone graft, will be planned. This based on the preoperative CBCT that is already present, by using both the licensed software and free software. The investigator will register patients' age, gender and cleft size and register the required time to complete the different planning steps, as well as list the number of actions to complete the planning, and the occurrence of software bugs. In addition, the learning effect will be examined through comparison of the different cases planned by the same surgeon. All patients will be planned twice with an interval of two weeks in order to measure intra-observer reliability. Moreover, a second surgeon will also plan the 10 cases to measure inter-observer reliability.
Main study endpoints The investigators hypothesize that the licensed software is more user-friendly, ensuring a significant shorter overall treatment planning time to create a model for accurate bone transfer from the iliac crest to the jawbone.
- Conditions
- Cleft Palate Children
- Keywords
- 3D virtual software, bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cleft patient requiring bone graft | Patients presenting at the division of maxillofacial surgery at the AZ Sint-Jan Brugge-Oostende av (Belgium) or the 1st department of pediatrics at the USemmelweis (Hungary) for bone graft surgery of the unilateral cleft receive a complete routine work-up, including a cone-beam CT (CBCT). |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of total virtual planning time
measurement of total virtual planning time, with a digital chronometer
Measured: preoperative
Secondary outcomes (2)
duration of segmentation of the cleft defect
measurement of segmentation of the cleft defect, with a digital chronometer
Measured: preoperative
duration of creation of the individual 3D template
measurement of duration of creation of the individual 3D template, with a digital chronometer
Measured: preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start12 Nov 2018
- Primary completion31 Jul 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Palate ChildrenStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krisztian Nagy, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994679
- Sponsor's protocol ID
- 2368
- Acronym
- VIR-CLEFT
- Status last verified
- Feb 2022
- First submitted
- 19 Jun 2019
- Last updated
- 25 Feb 2022
- 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 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Performance of Brainlab Iplan Software, in Comparison to Freeware for Virtual Bone Graft Planning in Unilateral Cleft Patients: a Retrospective, Pilot Study
- ClinicalTrials.gov ID
- NCT03994679
- Acronym / sponsor ID
- VIR-CLEFT / 2368
- Conditions
- Cleft Palate Children
- Keywords
- 3D virtual software, bone graft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 21 Jun 2019 (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.
Objective: The investigators aim to compare the licensed Brainlab Iplan® software, considered the gold standard, to the 3D slicers and Blender freeware for the segmentation of the unilateral cleft defect, as well as the creation of individual 3D template for development of the bone graft.
Study design Retrospective, pilot study Patients presenting at the division of maxillofacial surgery at the AZ Sint-Jan Brugge-Oostende av (Belgium) or the 1st department of pediatrics at the USemmelweis (Hungary) for bone graft surgery of the unilateral cleft receive a complete routine work-up, including a cone-beam CT (CBCT). A single surgeon will run all the virtual planning steps with both the licensed software and the freeware. Timing of the four major steps will be measured with a digital chronometer (http://www.online-stopwatch.com/download-stopwatch/).
Ten children, 5 Belgian patients and 5 Hungarian patients, that already had a work-up and surgery for a unilateral cleft requiring a bone graft, will be planned. This based on the preoperative CBCT that is already present, by using both the licensed software and free software. The investigator will register patients' age, gender and cleft size and register the required time to complete the different planning steps, as well as list the number of actions to complete the planning, and the occurrence of software bugs. In addition, the learning effect will be examined through comparison of the different cases planned by the same surgeon. All patients will be planned twice with an interval of two weeks in order to measure intra-observer reliability. Moreover, a second surgeon will also plan the 10 cases to measure inter-observer reliability.
Main study endpoints The investigators hypothesize that the licensed software is more user-friendly, ensuring a significant shorter overall treatment planning time to create a model for accurate bone transfer from the iliac crest to the jawbone.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cleft patient requiring bone graft | – | –Patients presenting at the division of maxillofacial surgery at the AZ Sint-Jan Brugge-Oostende av (Belgium) or the 1st department of pediatrics at the USemmelweis (Hungary) for bone graft surgery of the unilateral cleft receive a complete routine work-up, including a cone-beam CT (CBCT). |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Patients presenting at the division of maxillofacial surgery at the AZ Sint-Jan Brugge-Oostende av (Belgium) or the 1st department of pediatrics at the USemmelweis (Hungary) for bone graft surgery of the unilateral cleft receive a complete routine work-up, including a cone-beam CT (CBCT).
Key inclusion criteria (6 listed)
- Patients with a unilateral cleft
- Patients of all genders
- Patients aged 7-12 years old
- Patients should have presented themselves at the division of maxillofacial surgery, at the participating hospital centers, for bone graft surgery
- Patients should have received standardized cone-beam computed tomography (CBCT) image acquisition as part of routine work-up, and all original DICOM files should be present
Key exclusion criteria (4 listed)
- All patients that do not fit the abovementioned description
- Patients with previous bone graft surgery
- Patients with posttraumatic deformity
- Patients with preprosthetic indication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
duration of total virtual planning time
Time frame: preoperative
measurement of total virtual planning time, with a digital chronometer
2 secondary outcomes
duration of segmentation of the cleft defect
Time frame: preoperative
duration of creation of the individual 3D template
Time frame: preoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Palate Children, run by AZ Sint-Jan AV 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 25 Feb 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of total virtual planning time (time frame: preoperative). 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 25 Feb 2022.