Leonardo Ciocca Massimiliano Fantini Francesca De Crescenzio Franco Persiani Roberto Scotti

Computer-aided design and manufacturing construction of a surgical template for craniofacial implant positioning to support a denitive nasal prosthesis

Authors afliations: Leonardo Ciocca, Maxillo-Facial Prosthodontics, Section of Prosthodontics, Department of Oral Science, Alma Mater Studiorum University of Bologna, Bologna, Italy Massimiliano Fantini, Francesca De Crescenzio, Virtual Reality and Simulation Laboratory, II Engineering Faculty, Alma Mater Studiorum , Italy University of Bologna, Forl Franco Persiani, II Engineering Faculty, Alma Mater , Italy Studiorum University of Bologna, Forl Roberto Scotti, Oral and Maxillo-Facial Rehabilitation, Section of Prosthodontics, Department of Oral Science, Alma Mater Studiorum University of Bologna, Bologna, Italy Corresponding author: Dr Leonardo Ciocca Via S. Vitale 59 40125 Bologna Italy. Tel.: 39 051 208 8145 Fax: 39 051 22 5208 e-mail: leonardo.ciocca@unibo.it

Key words: CADCAM, craniofacial implants, nasal prosthesis, rapid prototyping, virtual surgery Abstract: Aim: To design a surgical template to guide the insertion of craniofacial implants for nasal prosthesis retention. Materials and methods: The planning of the implant position was obtained using software for virtual surgery; the positions were transferred to a free-form computer-aided design modeling software and used to design the surgical guides. A rapid prototyping system was used to 3D-print a three-part template: a helmet to support the others, a starting guide to mark the skin before ap elevation, and a surgical guide for bone drilling. An accuracy evaluation between the planned and the placed nal position of each implant was carried out by measuring the inclination of the axis of the implant (angular deviation) and the position of the apex of the implant (deviation at apex). Results: The implant in the glabella differed in angulation by 7.781, while the two implants in the premaxilla differed by 1.86 and 4.551, respectively. The deviation values at the apex of the implants with respect to the planned position were 1.17 mm for the implant in the glabella and 2.81 and 3.39 mm, respectively, for those implanted in the maxilla. Conclusions: The protocol presented in this article may represent a viable way to position craniofacial implants for supporting nasal prostheses.

Date: Accepted 5 August 2010

To cite this article: Ciocca L, Fantini M, De Crescenzio F, Persiani F, Scotti R. Computer-aided design and manufacturing construction of a surgical template for craniofacial implant positioning to support a denitive nasal prosthesis. Clin. Oral Impl. Res. 22, 2011; 850856. doi: 10.1111/j.1600-0501.2010.02066.x

Computer-aided design and manufacturing (CADCAM) technology is developing rapidly in the eld of maxillofacial prosthetics. In recent articles, we described protocols for elaborating and rapidly prototyping molds for auricular prostheses for a patient who required ablative surgery of the external ear for tumor removal (Ciocca et al. 2007a, 2007b) and for a patient affected by Treacher Collins syndrome (Ciocca et al. 2010a, 2010b). However, these previous reports did not discuss the problem of identifying the bone available for craniofacial implant insertion. Osseointegrated implants have various advantages over either adhesive or spectacle-retained devices for the reconstruction of an ablated nose (Ciocca et al. 2010a, 2010b). They provide better retention of the prosthesis, so that it is properly positioned and the patient can wear it more condently. The prosthesis can be made thinner, with feathered edges that blend with the skin, which offers the patient improved esthetics. Preoperative planning with the maxillofacial surgeon and the prosthodontist is vital for optimal outcomes: today, the

virtual planning of the craniofacial implant insertion and the rapid prototyping of the surgical template requires the collaboration of the CAD CAM specialist engineer. Many articles have described computerized technology without considering this important step and the procedure required for the correct positioning of craniofacial implants within the external volume of an ear or nasal prosthesis (Nusinov & Gay 1980; Mankovich et al. 1986; Girod et al. 1995; Beumer et al. 1998; Coward et al. 1999; Penkner et al. 1999; Runte et al. 2002; Cheah et al. 2003a, 2003b; Hecker 2003; Kubon & Anderson 2003; Lemon et al. 2003; Reitemeier et al. 2004; Mardini et al. 2005). Typically, the available bone in the glabella and the premaxilla is the major factor that determines implant position for retention of nasal prosthesis. Diagnosis and treatment planning are multi-disciplinary, and the use of new CADCAM technologies may improve implant-supported prosthetic rehabilitation. Borderline patients may be studied during the diagnostic phase using
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the virtual simulation of the surgery, avoiding surgical over-treatments or reducing more aggressive surgeries (Van Steenberghe et al. 2005; Balshi et al. 2006; Lal et al. 2006; Rosenfeld et al. 2006). However, no attempt has been made to guide the position of craniofacial implants using a prosthetic virtual simulation regarding the nal rehabilitation of the nose or a rapidly prototyped surgical template derived from this process. This article describes the computer-aided design and rapid prototyping of surgical template for the prosthetically guided insertion of craniofacial implants.

Material and methods

A 58-year-old man presenting with a total loss of the nose due to a gunshot was scheduled for a denitive nasal prosthesis, anchored on osseointegrated craniofacial implants (Fig. 1).
CT scan elaboration with NobelGuide
Fig. 1. Initial anatomy.

The CT data were uploaded into NobelGuide software (Nobel Biocare, Kloten, Switzerland) and elaborated to plan the implant surgery in the nasal region, where a sufcient quantity of available bone was present. Two implants were positioned in the premaxillary area in the nasal oor and one in the glabellar region. The length of the implants was 11.5 mm and the diameter was 3.75 mm. After positioning the implants, the frontal, lateral, and upper orthographic views (with and without the skeletal region of interest) were collected as JPG images (Fig. 2).
CT and laser scanner data integration

The CT data were uploaded into Amira 3.1.1 software (Mercury Computer Systems, Chelmsford, MA, USA) and elaborated to reconstruct the 3D digital model of the skull surface by setting the same threshold value used in NobelGuide (276 Hounseld Unit [HU]). The 3D digital model of the skin surface was also obtained by setting a suitable threshold value. Both models were achieved semi automatically by thresholdbased segmentation, contour extraction, and surface reconstruction. This process is particularly useful for distinguishing between soft tissues and skeletal structures. Moreover, to augment the obtained region of the face, CT data were integrated with laser scanner data that had been collected previously for designing and manufacturing the eyeglasses-supported provisional nasal prosthesis. In that instance, a laser scanner (NextEngine Desktop 3D Scanner; NextEngine, Santa Monica, CA, USA) was used to acquire the facial skin surface from ve (left, right, frontal, upper, lower) different perspectives, covering a wider area of the face with respect to CT data
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Fig. 2. Frontal, lateral, and upper views (with and without the skeletal region of interest) by NobelGuide.

acquisition focusing just on the nasal defect. As usual in reverse engineering post-processing, the ve scans have been carefully aligned and merged to obtain the nal digital model of the patients entire face. Skin surfaces from CT and laser scanner data were both imported into Rapidform

XOS2 (INUS Technology, Seoul, Korea) and registration process was carried out for data integration into a single coordinate system. Three pairs of corresponding reference points were selected on both skin surfaces (CT and laser scanner) for an initial rough alignment. When

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Digital models of skull surfaces from CTand skin surfaces from laser scanner were also imported for referencing in 3D space. After replacing background bitmaps with the images, with the skeletal region of interest, collected by NobelGuide, both digital models were moved, overlapping the skull surface with respect to the new background in each view (Fig. 5b).

Designing the template

Fig. 3. Skin surface from CT data (left), laser scanner data (center), and surface deviation analysis between CT and laser scanner data (right).

Once all the models had been imported into Rhino, a template with surgical guides for implants placement, as planned previously, was designed. It was developed in three parts: a main template for referencing on the patients head and two interchangeable overhanging surgical guides. The main template was designed as a customized helmet by the offset (5 mm) of the frontalupper part of the 3D digital model of the scanned face to ensure a correct matching with the head of the patient. A dovetail joint was added in the front for connecting the two surgical guides, both provided with guide cylinders. The rst surgical guide was designed just to mark the skin corresponding to the implants axis before surgically cutting the soft tissues, while the second one was developed to guide the drilling of the bone for implant placement (Fig. 6).

Rapid prototyping of the template

Fig. 4. Skull surface from CT data (left), skin and skull surfaces from CT data (center), and integration between the skull surface from CT data and skin surface from laser scanner data (right).

performing this operation, the rst selected shell (skin surface from laser scanner data) was moved to the second selected shell (skin surface from CT data). The renement of the alignment was performed semiautomatically using iterative closest points (ICP)-based ne registration. To evaluate the accuracy of the registration process, a surface deviation analysis between CT and laser scanner data was performed, yielding a distance mean value of o1 mm. The color map visualization of the surface deviation analysis is shown in Fig. 3: the regions with higher deviation were localized around the mouth and the residual left nasal ala, probably due to different facial expressions during the two data acquisition sessions. After the registration process, the skin surface acquired from the laser scanner was simply used to replace the skin surface reconstructed from CT data integration between skull surface from CT and skin surface from laser scanner (Fig. 4).

Virtual planning transfer

In Rhino 3.0 (Robert McNeel & Associates, Seattle, WA, USA), the frontal, lateral, and upper images, without the skeletal region of interest, collected by NobelGuide, were imported as background bitmaps in the corresponding views (scaled to match each other and located in space, so they all lined up). In each of the three views, background bitmaps were used as a guide to trace over the construction lines for the axis of the three implants. The Crv2View command (curves from two views) was used to create the axis of the three implants in 3D space by selecting the corresponding construction lines in two views. The implants were modeled as cylinders (diameter 3.75 mm and height 11.5 mm) and placed in 3D space according to the relative axis and the background bitmaps (Fig. 5a). For this kind of construction, just two views are necessary, but using three views avoid eventually problems due to overlapping of reference features in the images.

The helmet template and the two interchangeable overhanging surgical guides were directly manufactured using a 3D soluble support technology rapid prototyping system (Stratasys, Eden Prairie, MN, USA). The working principle is based on fused deposition modeling by acrylonitrile butadiene styrene plastic material (ABS P400) and soluble support material to sustain the prototype under construction. By this process, prototypes are built up layer by layer (thickness 0.254 mm) with two available lling options: solid and sparse. In the rst case, each section of the model is completely lled with ABS material. In the second one, the interior part of the model is replaced with a honeycomb structure. Solid lls are stronger and heavier, while sparse lls are weaker and lighter, saving material and speeding up the build process. Therefore, the digital models were exported in solid to layer format and directly prototyped in a single work session, choosing the sparse ll option for the helmet template and the solid ll option for the overhanging guides to obtain stronger elements. The process was completed by washing the models in an agitation system with a hot soapy water bath to remove all the support material for hands-free model completion (Fig. 7). Table 1 shows the amount and cost of the ABS and the support material consumed.
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Clinical procedure

Fig. 5. Virtual planning transfer (frontal and lateral views): implant modeling, according to background bitmaps (a) and skull positioning, according to background bitmaps (b).

The surgical template was tested on the patient, and the insertion procedure was checked in relation to the dimensions of the drill and the hand piece before surgical intervention (Fig. 8). The patient underwent general anesthesia for the surgery: before starting, the position of the surgical template was marked onto the skin with a skin pencil to facilitate repositioning during the second phase of the surgery. Then, the insertion landmark points were pointed on the skin and deeper, with a needle and dermographic ink, as a guide for ap elevation (Fig. 9a, b). A plastic surgery was executed to eliminate the left nasal ala, still present as residual structure from the rst emergency surgery. When the skull bone was exposed, the second surgical template was xed to the helmet and it was repositioned onto the head according to the lines previously marked. The surgical pilot drill was guided by the holes of the templates and a pin was inserted to test the inclination and the position with respect to the available bone. The insertion of implants (Branemark System RP TiUnite, Nobel Biocare) was performed according to the conventional protocol (Fig. 9c, d), and the aps were sutured covering the screw taps of the implants (Fig. 9e).

Results
A CT scan was performed after the surgery to verify the accuracy of the surgical protocol with respect to the CADCAM planned design. In Fig.

Fig. 7. Rapid prototyping of the surgical template for implant positioning: helmet template, starting guide to mark the skin, and surgical guides to drill the bone (in the glabellar region and in the premaxillary area).

Table 1. Material cost

Surgical template elements ABS material (cm3) 98.45 8.82 7.67 9.68 124.62 Support material (cm3) 116.30 4.60 3.70 5.82 130.42 Building time Cost of material (h )

Helmet template Surgical guide to mark the skin Surgical guide to drill the bone in the glabellar region Surgical guide to drill the bone in the premaxillary area Total

14 h 51.12 53 min 1 h 20 min 4.29 1 h 2 min 3.82 1 h 46 min 4.78

Fig. 6. Design of the surgical template for implant positioning: helmet template (a), starting guide to mark the skin (b), surgical guide to drill the bone in the glabellar region (c), and surgical guide to drill the bone in the premaxillary area (d).

19 h 1 min 64.01

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Fig. 8. Try-in of the surgical template on the patient and check of the insertion procedure.

10 are shown the frontal and lateral views of the radiographic control after implants placement to support the nasal prosthesis. The presence of previously placed implants for dental prosthesis and the distribution of bullets due to the gunshot can also be observed. The post-operative CT data were uploaded into Amira and elaborated to reconstruct the digital model of the skull surface by setting the same threshold value used previously (276 HU), and the 3D digital models of the inserted implants were reconstructed by setting a suitable threshold value. The digital models were imported in Rapidform XOS2 and the registration process was carried out by selecting three pairs of corresponding reference points on both skull surfaces (preand postsurgical intervention) for initial rough alignment. The renement of the alignment was performed using ICP registration. The process for pre- and postdata integration into the same coordinate system allowed comparison of the planned position with the real position of the implants in Rhino environment (Fig. 11). The accuracy between planned and placed was quantitatively evaluated by measuring two parameters: the inclination of the axis of the implant (angular deviation) and the position of the apex of the implant (deviation at apex; Table 2). Because the axes of planned and placed implants are represented by two straight lines in space that do not lie in a plane, the angular deviation is evaluated as the minor angle between two skew lines, dened as either of the angles between any two lines parallel to them and passing through a point in space. The implant in the glabella differed in angulation by 7.781, while the two implants in the premaxilla differed by 1.86 and 4.551, respectively. Consistent with literature data (Van Steenberghe et al. 2003; Di Giacomo et al. 2005; Ozan et al. 2009) for accuracy when using the CADCAM system during implant surgery, the angle deviation was acceptable in terms of safety and prosthetic implications. The deviation values at the apex of the implants with respect to the planned position were 1.17 mm for the implant in the glabella and 2.81 and 3.39 mm, respectively, for those implanted in the maxilla. The position of the implants resulted in the mean values of the data from the literature.

Discussion
Different computer-aided surgery systems harness the advantages of optimal 3D diagnosis and software-based planning by accurately transferring the virtual implant positions to the corresponding anatomical patients sites. Since 1997, different approaches for computer-assisted implant planning have been available for oral
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Fig. 9. Surgery: initial landmarking (a, b), implant positioning (c, d), and the ap suture (e).

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Fig. 10. Radiographic control after implants placement to support the nasal prosthesis (indicated by black arrows): (a) frontal view; (b) lateral view. In the radiography can also be noticed the presence of previously placed implants for dental prosthesis and the distribution of bullets due to the gunshot.

Fig. 11. Comparison between the planned (continuous line axis) and placed (dashed line axis) implant position to quantitatively evaluate the accuracy: (a) frontal view; (b) lateral view.

Table 2. Values of accuracy measurements

Site Glabella Maxilla 1 Maxilla 2 Deviation at apex (mm) 1.17 2.81 3.39 Angular deviation (1) 7.78 1.86 4.55

implants (Ewers et al. 2004; Mupparapu & Singer 2004), but none have been useful for the insertion of craniofacial implants. Moreover, although several studies have been published on the accuracy of these models (Tal & Moses 1991; DelBalso et al. 1994; White et al. 2001; Hatcher et al. 2003), no data are available on the accuracy of craniofacial implant positioning with respect to the planned position. This study presented a new protocol of constructing surgical templates for craniofacial im c 2010 John Wiley & Sons A/S

plants. Starting from a 3D system (NobelGuide, Nobel Biocare), planning of the ideal position of three craniofacial implants was carried out. The spatial position of each implant, represented in the NobelGuide, was transferred into CAD software that allowed projection of the surgical template. When the helmet and the inserts were prototyped and sterilized, the patient was scheduled for surgery. The main innovation in such a procedure was the integration of CT and laser scanner data as the starting point for the design of the surgical guide. Coordinate systems integration from multimodal devices has already been carried out for the generation of a craniofacial database (Suwardhi et al. 2005), but not for the purpose described in this paper. To reduce the patients exposure to X-rays, CT scanning should be focused on the effective region of interest, while the completely safe 3D

laser scanning may cover a much wider area. Thus, the CT scan, focused on the nasal defect, was integrated with 3D laser scanning of the entire face and head surface to design the customized helmet. The main problem of such a surgical guide was the stability: the helmet was designed on a rigid and xed frontal surface of the patient, while the skin is resilient and mobile. Even if the glabella landmark can be readily detected, minor pressure on the template may dislocate it in a wrong position. Taking care in positioning it with respect to the three landmarks (two supra-ocular bone arches and glabella) with no pressure on the skin, the template position was accurately marked on the frontal and lateral skin of the skull, so as to reproduce the same position each time the template was used. However, a bone pin retention system will also be necessary in the future for better stabilization of the template. As result of this main problem, the implant in the glabellar region was affected by an error in the inclination in spite of a very good placement position. The two implants in the premaxillary area in the nasal oor were more internally displaced with respect to the planned place due to a slightly incorrect repositioning of the helmet during the two-step drilling surgery. Moreover, they were both inserted into the bone tissue less in depth than planned. The main advantages of this protocol are the use of a CADCAM system to guide the implant surgery and to project the implant position according to prosthetic options. The rst advantage allows the surgeon to accurately plan the ap and the plastic surgery: in the case reported here, for example, a reduction in the thickness of the mucodermal ap in the oor of the nose was necessary to obtain a correct emerging prole of the healing/ prosthetic abutments. The second advantage allows the prosthodontist to take into account the prosthetic issues in terms of the inclination for a better impression and accessibility for home hygienic maintenance care around implants. The main disadvantages are that it is consuming and expensive due to the elaboration of the surgical template. Moreover, the rapid prototyping equipment (software and 3D printer) may represent a barrier.

Conclusions
The protocol presented here simplies the implant surgery for the insertion of craniofacial implants to support a nasal prosthesis. The surgical template can be rapidly manufactured using CADCAM technology in combination with other systems for virtual surgery. This protocol facilitates a more accurate positioning of craniofacial implants than unguided surgery.

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