Accuracy of Computer Guided Implant Surgery
Condition: Jaw, Edentulous
MeSH terms: Jaw, Edentulous
Study type: Interventional

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.
    

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 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.
    

Intervention name(s): Stereolitographic template
Intervention type(s): Other
Intervention description(s): Flapless (atraumatic) dental implants insertion with the aid of a stereolitographic template.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Stereolitographic guide; flapless surgery; dental implants