- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03852927
Computer Guided Contouring of Craniofacial Fibrous Dysplasia Involving Zygoma
Computer Guided Contouring of Craniofacial Fibrous Dysplasia Involving Zygoma: a Case Series
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt, 11728
- Recruiting
- Faculty of Dentistry, Cairo University
-
Contact:
- Sherif Ali
- Phone Number: +201001932020
- Email: sherif.ali@dentistry.cu.edu.eg
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy
Time Frame: 1 week after the surgical procedure
|
Preoperative plane and post-operative 3D CT scan will superimposed, and the difference between the planed and postoperative bone contour will be estimated.
|
1 week after the surgical procedure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-1-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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