Computer Guided Contouring of Craniofacial Fibrous Dysplasia Involving Zygoma
Primary Purpose
Craniofacial Fibrous Dysplasia
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Computer guided contouring
Sponsored by
About this trial
This is an interventional treatment trial for Craniofacial Fibrous Dysplasia
Eligibility Criteria
Inclusion Criteria:
- Monostotic unilateral craniofacial fibrous dysplasia.
- Facial asymmetry affecting zone I (fronto-orbital, zygomatic, and upper maxillary regions)
- More than 17 years
Exclusion Criteria:
- functional deficits
- orbital manifestations
Sites / Locations
- Faculty of dentistry, Cairo universityRecruiting
Outcomes
Primary Outcome Measures
Accuracy
Preoperative plane and post-operative 3D CT scan will superimposed, and the difference between the planed and postoperative bone contour will be estimated.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03852927
Brief Title
Computer Guided Contouring of Craniofacial Fibrous Dysplasia Involving Zygoma
Official Title
Computer Guided Contouring of Craniofacial Fibrous Dysplasia Involving Zygoma: a Case Series
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 25, 2019 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will be conducted on patients with monostotic unilateral craniofacial fibrous dysplasia affecting zone I (fronto-orbital, zygomatic, and upper maxillary regions). Computer guided shaving will be performed for all the patients, and the accuracy of this procedure will be assessed.
Detailed Description
This study will be conducted on patients with monostotic unilateral craniofacial fibrous dysplasia affecting zone I (fronto-orbital, zygomatic, and upper maxillary regions).
I. Preoperative preparation
Virtual planning Computed tomography (CT) will be performed for the skull using a multi-slice helical CT machine. Computed tomography DICOM (digital Imaging and Communication in Medicine) files will be imported to the 3D surgical planning software (Mimics 10.0, Materialise NV, Leuven, Belgium). Using the software and through a series of segmentation and simulation processes, area of interest will be virtually selected and separated. Finally, the virtual image of the surgical guide will be reconstructed.
Rapid prototyping Stereolithographic (STL) files of the virtual image will be exported to multi-jet modelling printing machine (InVision Si2, 3D Systems e Rock Hill, SC) and will be fabricated using plastic material (VisiJet SR 200, 3D Systems e Rock Hill, SC).
II. Surgical procedures Area of interest for all patients will be exposed using the hemicoronal, and maxillary intraoral vestibular incisions. The surgical guide(s) will be seated in position on the affected side. Bone removal will be performed through the guide according to the preoperative planning. The bone removal will be then performed to connect the guiding holes using surgical burs. Finally, the incisions will be sutured after soft tissue suspension.
III. Follow up Postoperative CT will be performed for postoperative assessment. After 1 week patients will be recalled for suture removal and clinical assessment. Then the patients will be recalled 1, 3 months for further assessment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craniofacial Fibrous Dysplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Computer guided contouring
Other Intervention Name(s)
Computer guided shaving
Intervention Description
Using virtual planing and rapid prototyping a surgical guide will be fabricated, and will be used for bone contouring of the bone lesion.
Primary Outcome Measure Information:
Title
Accuracy
Description
Preoperative plane and post-operative 3D CT scan will superimposed, and the difference between the planed and postoperative bone contour will be estimated.
Time Frame
1 week after the surgical procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Monostotic unilateral craniofacial fibrous dysplasia.
Facial asymmetry affecting zone I (fronto-orbital, zygomatic, and upper maxillary regions)
More than 17 years
Exclusion Criteria:
functional deficits
orbital manifestations
Facility Information:
Facility Name
Faculty of dentistry, Cairo university
City
Cairo
ZIP/Postal Code
11728
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherif Ali
Phone
+201001932020
Email
sherif.ali@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Computer Guided Contouring of Craniofacial Fibrous Dysplasia Involving Zygoma
We'll reach out to this number within 24 hrs