Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03994679
Other study ID # 2368
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 12, 2018
Est. completion date December 31, 2020

Study information

Verified date February 2022
Source AZ Sint-Jan AV
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 31, 2020
Est. primary completion date July 31, 2020
Accepts healthy volunteers
Gender All
Age group 7 Years to 12 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - All patients that do not fit the abovementioned description - Patients with previous bone graft surgery - Patients with posttraumatic deformity - Patients with preprosthetic indication

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Belgium AZ Sint-Jan Brugge-Oostende AV Brugge

Sponsors (1)

Lead Sponsor Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary duration of total virtual planning time measurement of total virtual planning time, with a digital chronometer preoperative
Secondary duration of segmentation of the cleft defect measurement of segmentation of the cleft defect, with a digital chronometer preoperative
Secondary duration of creation of the individual 3D template measurement of duration of creation of the individual 3D template, with a digital chronometer preoperative
See also
  Status Clinical Trial Phase
Recruiting NCT03995199 - A Comparison of Speech Outcome in Pediatric Cleft Patients, After Modified Furlow-Sommerlad Palatoplasty in Comparison to Modified Furlow Palatoplasty Alone
Not yet recruiting NCT03688737 - Low Level Laser in Isolated Cleft Palate Repair Versus Surgical Correction Without LLL in Healing Process N/A
Recruiting NCT06105099 - Effect of Performance-specific Cleft Speech Intervention and Long-term Learning in Children With a Cleft Palate N/A
Active, not recruiting NCT03799068 - Suprazygomatic Nerve Block vs Surgical Site Infiltration in Cleft Palate Repair N/A
Recruiting NCT06143254 - Effect of Infant Sign Training on Speech-language Development N/A
Enrolling by invitation NCT04909619 - Suprazygomatic Maxillary Nerve Block in Cleft Palate Outcomes N/A
Recruiting NCT05331456 - Alveolar Cleft Repair Using Osteoinductive Ceramics N/A
Not yet recruiting NCT06381713 - Effect and Cost-utility of of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate N/A