search
Back to results

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
Cairo University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Craniofacial Fibrous Dysplasia

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 22, 2019
Last Updated
February 22, 2019
Sponsor
Cairo University
search

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