Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423482
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-16
Brief Title:
Digitization Accuracy and Scannability of Two Different Implant-Supported Prosthodontic Framework Materials
Sponsor:
Nourhan Samy
Organization:
Alexandria University
Study Overview
Official Title:
Digitization Accuracy and Scannability of Two Different Implant-Supported Prosthodontic Framework Materials
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present study aims to clinically evaluate and compare the scanning accuracy and the scannability of 2 different materials used in constructing frameworks for implant-supported prosthesis titanium and PEEK
The objective of the present study is to evaluate the digitization accuracy and scannability of milled titanium and PEEK implant-supported frameworks in intra-oral conditions and to evaluate the accuracy of the superstructures designed and constructed over the intraorally scanned framework
The objective of the present study is to evaluate the digitization accuracy and scannability of milled titanium and PEEK implant-supported frameworks in intra-oral conditions and to evaluate the accuracy of the superstructures designed and constructed over the intraorally scanned framework
Detailed Description:
Background For implementing a fully digital workflow intraoral scanning of prosthetic frameworks may be required for editing purposes in some clinical scenarios Different materials can be used in constructing implant-supported prosthetic frameworks However the scannability and the influence of the material used on the accuracy of the intraoral scan are still unclear
Aim of the study The purpose of this in vivo study is to evaluate the scanning accuracy and the scannability of different framework materials and to assess the marginal adaptation and accuracy of the superstructures designed and constructed over different scanned framework materials
Materials and methods Two milled maxillary implant-supported frameworks constructed from 2 different materials will be used in this study Group I will be constructed from titanium and group II from Poly-Ether-Ether-Ketone PEEK The frameworks will be digitized by using a desktop scanner Tabletop Scanner Medit T-310 Medit Corp The STL file produced will be considered as a reference file Each framework will be scanned intraorally n10 by using an intraoral scanner IOS Medit i700 Medit Corp The STL files obtained from the intraoral scanner will be compared to the reference STL file to assess the scannability The unscanned surface area in a preset time limit will be used to determine the scannability of each framework To evaluate the scanning accuracy all STL files will be imported into a surface-matching software program Medit Design v306 Build 286 Medit Corp where deviation measurements in μm will be calculated A total of 20 superstructures made of nano-ceramic hybrid resin Flexcera Smile Ultra will be 3D-printed from each STL file obtained from intraoral scanning of the frameworks and then the marginal adaptation will be evaluated by using a stereomicroscope SZ1145TR Olympus Japan The accuracy will also be assessed by using a surface-matching software program Geomagic Control X v201811 3D Systems
Analysis Data will be collected tabulated and statistically analyzed by using the appropriate statistical tests
Keywords Digitization accuracy trueness precision scannability implant-supported frameworks superstructures marginal adaptation titanium PEEK digital workflow editing nano-ceramic hybrid resin
Aim of the study The purpose of this in vivo study is to evaluate the scanning accuracy and the scannability of different framework materials and to assess the marginal adaptation and accuracy of the superstructures designed and constructed over different scanned framework materials
Materials and methods Two milled maxillary implant-supported frameworks constructed from 2 different materials will be used in this study Group I will be constructed from titanium and group II from Poly-Ether-Ether-Ketone PEEK The frameworks will be digitized by using a desktop scanner Tabletop Scanner Medit T-310 Medit Corp The STL file produced will be considered as a reference file Each framework will be scanned intraorally n10 by using an intraoral scanner IOS Medit i700 Medit Corp The STL files obtained from the intraoral scanner will be compared to the reference STL file to assess the scannability The unscanned surface area in a preset time limit will be used to determine the scannability of each framework To evaluate the scanning accuracy all STL files will be imported into a surface-matching software program Medit Design v306 Build 286 Medit Corp where deviation measurements in μm will be calculated A total of 20 superstructures made of nano-ceramic hybrid resin Flexcera Smile Ultra will be 3D-printed from each STL file obtained from intraoral scanning of the frameworks and then the marginal adaptation will be evaluated by using a stereomicroscope SZ1145TR Olympus Japan The accuracy will also be assessed by using a surface-matching software program Geomagic Control X v201811 3D Systems
Analysis Data will be collected tabulated and statistically analyzed by using the appropriate statistical tests
Keywords Digitization accuracy trueness precision scannability implant-supported frameworks superstructures marginal adaptation titanium PEEK digital workflow editing nano-ceramic hybrid resin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None