Jaw, Edentulous Clinical Trial
Official title:
Accuracy of Computer Guided Implant Surgery With the Use of R2Gate Stereolitographic Template
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.
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 1.0.3 (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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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