Background:
Image-Guided Surgery (IGS) is used in a variety of medical procedures, for example by orthopedic, oral-maxillofacial, brain, sinus and spinal surgeons to help clarify complex anatomy encountered during surgical interventions or procedures. However, although use of Image Guided Surgery represents a state-of-the-art approach, this technique is presently used at the discretion of the operating surgeon and is not investigational. This is mainly because the ability to transfer image information to surgical reality has been, and continues to be, one of the most challenging problems of both IGS and Computer Assisted Surgery. An innovative system called ImplaNavTM (BresMedical, Sydney, 2015) has been developed for oral and maxillofacial surgical navigation, in order to generate three-dimensional volumetric representations of the maxillofacial area, which allow surgeons to evaluate a patient's anatomy before surgery and assist in planning for the placement of implants in appropriate , ideal or preferred positions
Aim/Hypothesis:
The objective of this study is to evaluate the accuracy of the ImplaNavTM software and registration tools by presenting results obtained deploying the system in-vitro and in-vivo cases. The investigation focuses on how the surgical guidance, by way of visualization of a surgeon's instrument via optical tracking offered by the ImplaNavTM system, generates an immediate feedback on the possible misplacement or positioning of a dental implant or surgical drill guide
Material and Methods:
As regards the in-vitro evaluation, implant site preparation has been simulated on a polymeric replica of a mandible model on which a radio-opaque drill tip was inserted in its ideal position. A Cone Beam CT scan of the model has been used to perform the virtual surgical planning within the ImplaNavTM software. Once planned, the surgery has been simulated in tracking mode and the spatial deviation between the position of the virtual surgical instrument with respect to the radio-opaque scanned one has been quantified using Mimics ( Materialise NV, Leuven, Belgium). In in-vivo evaluation has been carried on NUMBER patients according to the ImplaNav 01.14 Protocol approved by the Ethical Committee. A pre-operative CT scan was taken with a teeth supported and bone-supported reference tool respectively for partially and totally edentulous patients. Virtual insertion of mandibular and maxillary implants has been performed through the ImplaNavTM software and the resultant surgical plan has been used to guide the actual surgery undertaken in tracking mode. Pre-operative and post-operative scans have been spatially aligned and the inserted implants have been segmented from the volume using the Multimod Application Framework (Cineca, Rome, Italy). Finally, a quantitative analysis of the deviation between the virtually planned implants and the physically inserted ones has been carried on using Mimics ( Materialise NV, Leuven, Belgium)
Results:
Results from the in-vitro trials show that in on the anteroposterior plane there is average apical difference of 0.95 mm between the tip of the radio-opaque drill and the tip of the surgical one while there is an average angle of 1.68 degrees between the respective axes. On a vestibulo-lingual plane the apical difference is 0.71 mm while the angle is 1.54 degrees. The in-vivo studies show a maximum 3D spatial of 2.5 mm between the virtual planning and the surgically inserted implants and a maximum 4 degrees angular deviation between the implant axes. Moreover, because of the live feedback from the surgical instrument tracking, the implant site preparation could be completed even if the pre-operatory virtual planning had to be changed during surgery because of the sensitivity of the adjacent anatomical structures
Conclusions and clinical implications:
The system used in this study could become of routine use just as surgical drill guides due to its accuracy in intra-oral surgery. In addition it facilitates surgical guidance in cases such as implant placement in sites of bone regeneration or limited inter-occlusal distance for drill guide. Finally, its dedicated software and tools are specifically designed to be easy to use clinically
Background:
Image-Guided Surgery (IGS) is used in a variety of medical procedures, for example by orthopedic, oral-maxillofacial, brain, sinus and spinal surgeons to help clarify complex anatomy encountered during surgical interventions or procedures. However, although use of Image Guided Surgery represents a state-of-the-art approach, this technique is presently used at the discretion of the operating surgeon and is not investigational. This is mainly because the ability to transfer image information to surgical reality has been, and continues to be, one of the most challenging problems of both IGS and Computer Assisted Surgery. An innovative system called ImplaNavTM (BresMedical, Sydney, 2015) has been developed for oral and maxillofacial surgical navigation, in order to generate three-dimensional volumetric representations of the maxillofacial area, which allow surgeons to evaluate a patient's anatomy before surgery and assist in planning for the placement of implants in appropriate , ideal or preferred positions
Aim/Hypothesis:
The objective of this study is to evaluate the accuracy of the ImplaNavTM software and registration tools by presenting results obtained deploying the system in-vitro and in-vivo cases. The investigation focuses on how the surgical guidance, by way of visualization of a surgeon's instrument via optical tracking offered by the ImplaNavTM system, generates an immediate feedback on the possible misplacement or positioning of a dental implant or surgical drill guide
Material and Methods:
As regards the in-vitro evaluation, implant site preparation has been simulated on a polymeric replica of a mandible model on which a radio-opaque drill tip was inserted in its ideal position. A Cone Beam CT scan of the model has been used to perform the virtual surgical planning within the ImplaNavTM software. Once planned, the surgery has been simulated in tracking mode and the spatial deviation between the position of the virtual surgical instrument with respect to the radio-opaque scanned one has been quantified using Mimics ( Materialise NV, Leuven, Belgium). In in-vivo evaluation has been carried on NUMBER patients according to the ImplaNav 01.14 Protocol approved by the Ethical Committee. A pre-operative CT scan was taken with a teeth supported and bone-supported reference tool respectively for partially and totally edentulous patients. Virtual insertion of mandibular and maxillary implants has been performed through the ImplaNavTM software and the resultant surgical plan has been used to guide the actual surgery undertaken in tracking mode. Pre-operative and post-operative scans have been spatially aligned and the inserted implants have been segmented from the volume using the Multimod Application Framework (Cineca, Rome, Italy). Finally, a quantitative analysis of the deviation between the virtually planned implants and the physically inserted ones has been carried on using Mimics ( Materialise NV, Leuven, Belgium)
Results:
Results from the in-vitro trials show that in on the anteroposterior plane there is average apical difference of 0.95 mm between the tip of the radio-opaque drill and the tip of the surgical one while there is an average angle of 1.68 degrees between the respective axes. On a vestibulo-lingual plane the apical difference is 0.71 mm while the angle is 1.54 degrees. The in-vivo studies show a maximum 3D spatial of 2.5 mm between the virtual planning and the surgically inserted implants and a maximum 4 degrees angular deviation between the implant axes. Moreover, because of the live feedback from the surgical instrument tracking, the implant site preparation could be completed even if the pre-operatory virtual planning had to be changed during surgery because of the sensitivity of the adjacent anatomical structures
Conclusions and clinical implications:
The system used in this study could become of routine use just as surgical drill guides due to its accuracy in intra-oral surgery. In addition it facilitates surgical guidance in cases such as implant placement in sites of bone regeneration or limited inter-occlusal distance for drill guide. Finally, its dedicated software and tools are specifically designed to be easy to use clinically
Background:
Image-Guided Surgery (IGS) is used in a variety of medical procedures, for example by orthopedic, oral-maxillofacial, brain, sinus and spinal surgeons to help clarify complex anatomy encountered during surgical interventions or procedures. However, although use of Image Guided Surgery represents a state-of-the-art approach, this technique is presently used at the discretion of the operating surgeon and is not investigational. This is mainly because the ability to transfer image information to surgical reality has been, and continues to be, one of the most challenging problems of both IGS and Computer Assisted Surgery. An innovative system called ImplaNavTM (BresMedical, Sydney, 2015) has been developed for oral and maxillofacial surgical navigation, in order to generate three-dimensional volumetric representations of the maxillofacial area, which allow surgeons to evaluate a patient's anatomy before surgery and assist in planning for the placement of implants in appropriate , ideal or preferred positions
Aim/Hypothesis:
The objective of this study is to evaluate the accuracy of the ImplaNavTM software and registration tools by presenting results obtained deploying the system in-vitro and in-vivo cases. The investigation focuses on how the surgical guidance, by way of visualization of a surgeon's instrument via optical tracking offered by the ImplaNavTM system, generates an immediate feedback on the possible misplacement or positioning of a dental implant or surgical drill guide
Material and Methods:
As regards the in-vitro evaluation, implant site preparation has been simulated on a polymeric replica of a mandible model on which a radio-opaque drill tip was inserted in its ideal position. A Cone Beam CT scan of the model has been used to perform the virtual surgical planning within the ImplaNavTM software. Once planned, the surgery has been simulated in tracking mode and the spatial deviation between the position of the virtual surgical instrument with respect to the radio-opaque scanned one has been quantified using Mimics ( Materialise NV, Leuven, Belgium). In in-vivo evaluation has been carried on NUMBER patients according to the ImplaNav 01.14 Protocol approved by the Ethical Committee. A pre-operative CT scan was taken with a teeth supported and bone-supported reference tool respectively for partially and totally edentulous patients. Virtual insertion of mandibular and maxillary implants has been performed through the ImplaNavTM software and the resultant surgical plan has been used to guide the actual surgery undertaken in tracking mode. Pre-operative and post-operative scans have been spatially aligned and the inserted implants have been segmented from the volume using the Multimod Application Framework (Cineca, Rome, Italy). Finally, a quantitative analysis of the deviation between the virtually planned implants and the physically inserted ones has been carried on using Mimics ( Materialise NV, Leuven, Belgium)
Results:
Results from the in-vitro trials show that in on the anteroposterior plane there is average apical difference of 0.95 mm between the tip of the radio-opaque drill and the tip of the surgical one while there is an average angle of 1.68 degrees between the respective axes. On a vestibulo-lingual plane the apical difference is 0.71 mm while the angle is 1.54 degrees. The in-vivo studies show a maximum 3D spatial of 2.5 mm between the virtual planning and the surgically inserted implants and a maximum 4 degrees angular deviation between the implant axes. Moreover, because of the live feedback from the surgical instrument tracking, the implant site preparation could be completed even if the pre-operatory virtual planning had to be changed during surgery because of the sensitivity of the adjacent anatomical structures
Conclusions and clinical implications:
The system used in this study could become of routine use just as surgical drill guides due to its accuracy in intra-oral surgery. In addition it facilitates surgical guidance in cases such as implant placement in sites of bone regeneration or limited inter-occlusal distance for drill guide. Finally, its dedicated software and tools are specifically designed to be easy to use clinically
Background:
Image-Guided Surgery (IGS) is used in a variety of medical procedures, for example by orthopedic, oral-maxillofacial, brain, sinus and spinal surgeons to help clarify complex anatomy encountered during surgical interventions or procedures. However, although use of Image Guided Surgery represents a state-of-the-art approach, this technique is presently used at the discretion of the operating surgeon and is not investigational. This is mainly because the ability to transfer image information to surgical reality has been, and continues to be, one of the most challenging problems of both IGS and Computer Assisted Surgery. An innovative system called ImplaNavTM (BresMedical, Sydney, 2015) has been developed for oral and maxillofacial surgical navigation, in order to generate three-dimensional volumetric representations of the maxillofacial area, which allow surgeons to evaluate a patient's anatomy before surgery and assist in planning for the placement of implants in appropriate , ideal or preferred positions
Aim/Hypothesis:
The objective of this study is to evaluate the accuracy of the ImplaNavTM software and registration tools by presenting results obtained deploying the system in-vitro and in-vivo cases. The investigation focuses on how the surgical guidance, by way of visualization of a surgeon's instrument via optical tracking offered by the ImplaNavTM system, generates an immediate feedback on the possible misplacement or positioning of a dental implant or surgical drill guide
Material and Methods:
As regards the in-vitro evaluation, implant site preparation has been simulated on a polymeric replica of a mandible model on which a radio-opaque drill tip was inserted in its ideal position. A Cone Beam CT scan of the model has been used to perform the virtual surgical planning within the ImplaNavTM software. Once planned, the surgery has been simulated in tracking mode and the spatial deviation between the position of the virtual surgical instrument with respect to the radio-opaque scanned one has been quantified using Mimics ( Materialise NV, Leuven, Belgium). In in-vivo evaluation has been carried on NUMBER patients according to the ImplaNav 01.14 Protocol approved by the Ethical Committee. A pre-operative CT scan was taken with a teeth supported and bone-supported reference tool respectively for partially and totally edentulous patients. Virtual insertion of mandibular and maxillary implants has been performed through the ImplaNavTM software and the resultant surgical plan has been used to guide the actual surgery undertaken in tracking mode. Pre-operative and post-operative scans have been spatially aligned and the inserted implants have been segmented from the volume using the Multimod Application Framework (Cineca, Rome, Italy). Finally, a quantitative analysis of the deviation between the virtually planned implants and the physically inserted ones has been carried on using Mimics ( Materialise NV, Leuven, Belgium)
Results:
Results from the in-vitro trials show that in on the anteroposterior plane there is average apical difference of 0.95 mm between the tip of the radio-opaque drill and the tip of the surgical one while there is an average angle of 1.68 degrees between the respective axes. On a vestibulo-lingual plane the apical difference is 0.71 mm while the angle is 1.54 degrees. The in-vivo studies show a maximum 3D spatial of 2.5 mm between the virtual planning and the surgically inserted implants and a maximum 4 degrees angular deviation between the implant axes. Moreover, because of the live feedback from the surgical instrument tracking, the implant site preparation could be completed even if the pre-operatory virtual planning had to be changed during surgery because of the sensitivity of the adjacent anatomical structures
Conclusions and clinical implications:
The system used in this study could become of routine use just as surgical drill guides due to its accuracy in intra-oral surgery. In addition it facilitates surgical guidance in cases such as implant placement in sites of bone regeneration or limited inter-occlusal distance for drill guide. Finally, its dedicated software and tools are specifically designed to be easy to use clinically