NCT03277443|UnknownDMC
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Sponsor study identifier
interventional
14
0 countries
N/A
Study Start
February 20, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 30, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
In patient with skeletal open bite, Dose computer-aided surgery enhances the clinical outcomes and accuracy versus conventional model surgery
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 6, 2017
Actual (reported)September 11, 2017
Actual (reported)February 20, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Accuracy of movement of surgical segments in millimeter
Computer guided Super-imposition of virtual surgery over the post- operative CT Scan composite models (millimeter mm). Conventional Super-imposition of scanned articulator with mounted casts in the pre-planned mock surgery over post-operative scanned mounted occlusion- accuracy would be compared by difference between Intervention and control in (millimeter mm).
up to 4 months
Anterior open Bite Closure (positive overbite in millimeter)
up to 4 months
Lateral Cephalogram with analysis and tracing of facial profile. Modified model surgical tecnique: 1. Obtain wax bite registration. 2. Record face-bow transfer. 3. Duplication of articulating model for surgical simulation. 4. Measure all casts and bases in standard model surgery fashion. 5. Fabricate intermediate splint \& Final splint. 6. Condylar repositional splint.
Preoperative surgical simulation and immediate postoperative evaluation will be carried out using Multi Slice CT scan. Computer-aided planning for study group: All planning will be done using specialized software (Anatomage Invivo 5.3) for preoperative surgical simulation and immediate postoperative evaluation. Pre-operative Fabrication of computer aided surgical splint: In the study group a stereo splint will be fabricated using rapid prototyping (RP) technique to guide the osteotomy and another one will be fabricated after virtual osteotomy to guide the surgical cuts. And stent for guided holes. So that the osteotomy will be accomplished by the aid of computer guided templates that simulates the proper bite achieved preoperatively during surgical simulation and Planning.
Preoperative surgical simulation and immediate postoperative evaluation will be carried out using Multi Slice CT scan.Craniofacial images from 3D computerized tomography (3D-CT scan) can be used to create a 3D model, which can in turn be used for 3D Cephalometry measurements and surgical simulation.The process of 3D-model contains mounting of 3D virtual models in a 3D virtual articulator; and repositioning of 3D virtual models according to the STO then Fabrication of a 3D virtual intermediate surgical wafer; and materialization of the surgical wafer using a stereolithographic technique. The 3D model can produce actual movement of surgical cuts and movement of segments accordingly
Moustafa K Ezz, Professor
Cairo University
First Submitted
September 6, 2017
First Posted
September 11, 2017
Study Start
February 20, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Anterior Open Bite Treatment With Bonded Spurs Associated With Build-ups Versus Conventional Bonded Spurs
preparation for orthognathic surgery which involves diagnosis with 2D cephalometric radiograph, face-bow transfer and model surgery on plaster dental cast, and fabrication of intermediate and final occlusal splint.
2D cephalometric radiograph
3D computerized tomography
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Primary Completion
December 30, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 14, 2018
Record last verified: 2018-02
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