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Computer Guided Contouring of Craniofacial Fibrous Dysplasia Involving Zygoma

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ClinicalTrials.gov Identifier: NCT03852927
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Sherif Ali, Cairo University

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
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 : January 25, 2019
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: 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.
    Other Name: Computer guided shaving


Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852927


Locations
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Egypt
Faculty of dentistry, Cairo university Recruiting
Cairo, Egypt, 11728
Contact: Sherif Ali    +201001932020    sherif.ali@dentistry.cu.edu.eg   
Sponsors and Collaborators
Cairo University

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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: February 25, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibrous Dysplasia of Bone
Craniofacial Fibrous Dysplasia
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases