Computer Guided Contouring of Craniofacial Fibrous Dysplasia Involving Zygoma

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03852927

Collaborator

(none)

Enrollment

Location

10.2

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Craniofacial Fibrous Dysplasia	Procedure: Computer guided contouring	N/A

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).

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).

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.
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 Design

Study Type:

Interventional

Anticipated Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Computer Guided Contouring of Craniofacial Fibrous Dysplasia Involving Zygoma: a Case Series

Actual Study Start Date :

Jan 25, 2019

Anticipated Primary Completion Date :

Mar 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Outcome Measures

Primary Outcome Measures

Accuracy [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of dentistry, Cairo university	Cairo		Egypt	11728

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sherif Ali, Lecturer of oral and maxillofacial surgery, Cairo University

ClinicalTrials.gov Identifier:

NCT03852927

Other Study ID Numbers:

19-1-20

First Posted:

Feb 25, 2019

Last Update Posted:

Feb 25, 2019

Last Verified:

Feb 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fibrous Dysplasia of Bone

Craniofacial Fibrous Dysplasia

Study Results

No Results Posted as of Feb 25, 2019