Computer Guided Contouring of Craniofacial Fibrous Dysplasia Involving Zygoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03852927|
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : February 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Craniofacial Fibrous Dysplasia||Procedure: Computer guided contouring||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- 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
- 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.
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
|Faculty of dentistry, Cairo university||Recruiting|
|Cairo, Egypt, 11728|
|Contact: Sherif Ali +201001932020 email@example.com|