Ignite Creation Date:
2024-05-06 @ 3:56 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02418117
Status:
COMPLETED
Last Update Posted:
2016-01-27
First Post:
2015-04-09
Brief Title:
Accuracy of Computer Guided Implant Surgery
Sponsor:
Concordia Dent Srl
Organization:
Concordia Dent Srl
Study Overview
Official Title:
Accuracy of Computer Guided Implant Surgery With the Use of R2Gate Stereolitographic Template
Status:
COMPLETED
Status Verified Date:
2016-01
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:
STIMPLANTSRG
Brief Summary:
The investigators aim is to evaluate the accuracy of the stereolitographic template comparing the final implant insertion to the planned implant position at coronal and apical level
Clinical relevance
To identify factors influencing the surgical template imprecision
To overcome risk factors for surgical template imprecision
To suggest improvements for highly accuracy of the surgical template especially for immediate loading and avoiding the injury of anatomical structures
Clinical relevance
To identify factors influencing the surgical template imprecision
To overcome risk factors for surgical template imprecision
To suggest improvements for highly accuracy of the surgical template especially for immediate loading and avoiding the injury of anatomical structures
Detailed Description:
Initial examination panoramic radiograph to be performed and impression for stone models to be taken to all enrolled patients For diagnosis accuracy impression of the surgical site and the opposite arch is mandatory
For fully edentulous and extensive edentulous subjects - Class III and IV according to the American College of Prosthodontists - ACP - a visible light cure record bases with occlusal rims will be manufactured for bite registration
CBCT will be taken with a R2 tray filled with impression material or with record basis in centric relation CR
CBCT will be performed using same CT machine with a specific setup and alignment to allow accuracy and reproducibility
A series of axially sliced image data will be obtained and exported to a personal computer in DICOM Digital Imaging and Communications in Medicine format
Models occlusal rims and R2 trays will be scanned and imported as STL Stereo Lithography files
On the scan models a virtual wax-up will be designed with the use of 3Shape CAD Computer Aided Design software and saved as STL file
Matching CT and models scan data DICOM files obtained from CBCT and STL files will be imported in a treatment plan software R2GATE version 103 Megagen Implant Korea and implant insertion will be planned according to the final restoration and bone anatomy
AnyRidge Megagen implants will be used with length and diameters required by the clinical cases
A stereolitographic template manufactured by DDX Europa after final decision of treatment plan will be used for dental implants insertion using a minimally invasive flapless approach
To assess accuracy of the surgical template a new CBCT with specific set-up and alignment after implant insertion will be performed
Matching post-op CT with the planed position of the implants will be performed using the R2GATE software and measurements between the location of implants on CT at the time of planning and after implantation will be made at the coronal and apical levels to determine the distance between the implant and the planned position buccal oral mesial and distal by two independent researchers Angulation between the implant position and the planned position at coronal and apical level will be also measured
Statistical analysis will be performed Teeth supported mucosal supported and teeth-mucosal supported surgical stereolitographic template will be analyzed separately
For fully edentulous and extensive edentulous subjects - Class III and IV according to the American College of Prosthodontists - ACP - a visible light cure record bases with occlusal rims will be manufactured for bite registration
CBCT will be taken with a R2 tray filled with impression material or with record basis in centric relation CR
CBCT will be performed using same CT machine with a specific setup and alignment to allow accuracy and reproducibility
A series of axially sliced image data will be obtained and exported to a personal computer in DICOM Digital Imaging and Communications in Medicine format
Models occlusal rims and R2 trays will be scanned and imported as STL Stereo Lithography files
On the scan models a virtual wax-up will be designed with the use of 3Shape CAD Computer Aided Design software and saved as STL file
Matching CT and models scan data DICOM files obtained from CBCT and STL files will be imported in a treatment plan software R2GATE version 103 Megagen Implant Korea and implant insertion will be planned according to the final restoration and bone anatomy
AnyRidge Megagen implants will be used with length and diameters required by the clinical cases
A stereolitographic template manufactured by DDX Europa after final decision of treatment plan will be used for dental implants insertion using a minimally invasive flapless approach
To assess accuracy of the surgical template a new CBCT with specific set-up and alignment after implant insertion will be performed
Matching post-op CT with the planed position of the implants will be performed using the R2GATE software and measurements between the location of implants on CT at the time of planning and after implantation will be made at the coronal and apical levels to determine the distance between the implant and the planned position buccal oral mesial and distal by two independent researchers Angulation between the implant position and the planned position at coronal and apical level will be also measured
Statistical analysis will be performed Teeth supported mucosal supported and teeth-mucosal supported surgical stereolitographic template will be analyzed separately
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None