Computer Guided Contouring of Craniofacial Fibrous Dysplasia Involving Zygoma

NCT ID: NCT03852927

Last Updated: 2019-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-25
• Study Completion Date: 2019-12-31

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

1. 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.

2. 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.

Conditions

Craniofacial Fibrous Dysplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Computer guided contouring

Using virtual planing and rapid prototyping a surgical guide will be fabricated, and will be used for bone contouring of the bone lesion.

Intervention Type: PROCEDURE

Other Intervention Names

Computer guided shaving

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

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sherif Ali

Lecturer of oral and maxillofacial surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of dentistry, Cairo university

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Sherif Ali

Role: primary

sherif.ali@dentistry.cu.edu.eg

+201001932020

Other Identifiers

19-1-20

Identifier Type: -

Identifier Source: org_study_id