Computer Guided Contouring of Craniofacial Fibrous Dyspla... | NCT03852927

Studies
Computer Guided Contouring of Craniofacial Fibrous Dysplasia Involving Zygoma

NCT03852927

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Feb 25, 2019Actual

Enrollment

5Estimated

Phase

Not Applicable

Conditions

Craniofacial Fibrous Dysplasia

Interventions

Computer guided contouring

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 25, 2019Actual

Primary Completion Date

Mar 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Feb 22, 2019

First Submission Date that Met QC Criteria

Feb 22, 2019

First Posted Date

Feb 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2019

Last Update Posted Date

Feb 25, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sherif Ali, Lecturer of oral and maxillofacial surgery, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Computer guided contouring	Procedure	Using virtual planing and rapid prototyping a surgical guide will be fabricated, and will be used for bone contouring of the bone lesion.		Computer guided shaving

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of dentistry, Cairo university	Recruiting	Cairo		11728	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000077275	Craniofacial Fibrous Dysplasia

Ancestor Terms

ID	Term
D005357	Fibrous Dysplasia of Bone
D010009	Osteochondrodysplasias
D001848	Bone Diseases, Developmental
D001847	Bone Diseases

Browse Leaves

Not provided

Browse Branches

Not provided