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How useful is 3D printing in maxillofacial surgery?
Accepted Manuscript Title: How useful is 3D printing in maxillo-facial surgery? Author: A. Louvrier P. Marty E. Weber E. Euvrard B. Chatelain A. Barrab´e C. Meyer PII: DOI: Reference:
S2468-7855(17)30119-2 http://dx.doi.org/doi:10.1016/j.jormas.2017.07.002 JORMAS 74
To appear in:
Please cite this article as: A. LouvrierP. MartyE. WeberE. EuvrardB. ChatelainA. Barrab´eC. Meyer How useful is 3D printing in maxillo-facial surgery? (2017), http://dx.doi.org/10.1016/j.jormas.2017.07.002 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
How useful is 3D printing in maxillo-facial surgery? Louvrier A1,2,*, Marty P1,2, Weber E1, Euvrard E1,2,3, Chatelain B1, Barrabé A1,2, Meyer C1,2,3 1: Department of Oral and Maxillofacial Surgery, University Hospital of Besançon, Boulevard Fleming, 25030 Besançon Cedex, France. 2: University of Franche-Comté, UFR SMP, 19 Rue Ambroise Paré, 25000 Besançon, France. 3: Nanomedicine Lab, Imagery and Therapeutics, EA 4662, UFR Sciences & Techniques, Université de Franche-Comté, Route de Gray, 25030 Besançon Cedex, France.
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*Corresponding author: [email protected]
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Abstract Introduction: 3D-printing seems to have more and more applications in maxillofacial surgery (MFS), particularly since the release on the market of general use 3D-printers several years ago. The aim of our study was to answer 4 questions: 1. Who uses 3D printing in MFS and is it routine or not? 2. What are the main clinical indications for 3D-printing in MFS and what are the kinds of objects that are used? 3. Are these objects printed by an official medical device (MD) manufacturer or made directly within the department or the lab? 4. What are the advantages and drawbacks?
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Methodology: Two bibliographic researches were conducted on January the 1st, 2017 in PubMed, without time limitation, using “maxillofacial surgery” AND “3D printing” for the first and for the second “maxillofacial surgery” AND “computer-aided design” AND “computer-aided manufacturing” as keywords. Articles in English or French dealing with human clinical use of 3D printing were selected. Publication date, nationality of the authors, number of patients treated, clinical indication(s), type of printed object(s), type of printing (lab/hospital-made or professional/industry) and advantages/drawbacks were recorded.
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Results: 297 articles from 35 countries met the criteria. The most represented country was the People’s Republic of China (16% of the articles). A total of 2,889 patients (10 per article on average) benefited from 3D-printed objects. The most frequent clinical indications were dental implant surgery and mandibular reconstruction. The most frequently printed objects were surgical guides and anatomic models. 45% of the prints were professional. The main advantages were improvement in precision and reduction of surgical time. The main disadvantages were the cost of the objects and the manufacturing period when printed by the industry.
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Discussion: The arrival on the market of low-cost printers has increased the use of 3D-printing in MFS. Anatomic models are not considered to be MDs and do not have to follow any regulation. Nowadays they are easily printed with low-cost printers. They allow for better preoperative planning and training for the procedures and for pre-shaping of plates. Occlusal splints and surgical guides are intended for the smooth transfer of planning to the operating room. They are considered to be MDs and even if they are easy to print, they have to follow the regulations applying to MDs. Patient specific implants (custom-made plates and skeletal reconstruction modules) are much more demanding objects and their manufacturing remains nowadays in the hands of the industry. The main limitation of in-hospital 3D-printing is the restrictive regulations applying to MDs. The main limitations of professional 3D-printing are the cost and the lead time. 3D-printed objects are nowadays easily available in MFS. However, they will never replace a surgeon’s skill and should only be considered as useful tools. Key-words: maxillofacial surgery, 3D printing, computer-aided design, computer-aided manufacturing, review
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Introduction
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The use of 3D printing in maxillofacial surgery (MFS) is not new. It started 30 years ago [1,2] but remained, until recently, in the hands of industry. For about the past ten years of general use, the availability of low cost 3D printers has revived surgeons’ interest in this technology. Applications seem to have become broader and broader, going from simple anatomic models to patient specific implants (PSIs), including cutting or drilling guides. The goal of our study was to evaluate the real interest of 3D printing in MFS by answering 4 questions: 1. Who, worldwide, is using 3D printing in CMFS and is it routine or not? 2. What are the main clinical indications for 3D printed objects in CMFS and, in these indications, what are the type of objects that are used? 3. Are these objects printed by an official medical device manufacturer or, on the contrary, made directly within the department itself or within a research lab? 4. What are the reported advantages and drawbacks?
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Material and methods
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Two bibliographic researches were conducted on January the 1st, 2017 in PubMed, without time limitation, using “maxillofacial surgery” AND “3D printing” as keywords for the first and “maxillofacial surgery” AND “computer-aided design” AND “computer-aided manufacturing” as keywords for the second. Inclusion criteria were human clinical use and French or English as the language of publication. Articles without available on-line abstracts or dealing with 3D printing on a micro- or nanoscale or concerning animal experiments or pure research papers, updates or reviews of the literature were excluded. For each selected article, we underlined the publication date, the nationality of the authors, the number of patients treated, the clinical indication(s), the type of printed object(s), who did the prints (manufacturer or hospital physicians) when this information was available, advantages/drawbacks reported by the authors.
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Results
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From the 1047 articles found on PubMed by using the research strategies, 405 were selected from their abstracts and 297 met all the inclusion criteria after complete reading (fig. 1). The oldest article dated back to 1993 [3] and the most recent to May 2017 [4]. These articles came from 35 different countries (fig. 2). The most represented country was the People’s Republic of China with 16% of the articles. France ranked in 8th position with 4% of the articles.
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The number of patients treated by means of a 3D-printed object varied from 1 to 215 per article with an average of 10 patients. 121 articles (41%) mentioned only 1 patient. The biggest series was about 215 patients and concerned the placement of 362 custom-made temporo-mandibular joint prosthesis [5]. Clinical indications were gathered into 15 categories (fig. 3). Some authors reported several indications in the same article, as did Levine et al. in 2012 (more than 4 categories) [6]. The main indications were dental implant placement and mandibular reconstruction, mainly when using fibula free flaps. 3D-printed objects were classified into 5 categories: anatomic models, surgical (cutting, drilling, positioning) guides, occlusal splints, PSIs (osteosynthesis plates, skeletal reconstruction parts…), facial epithesis. 59% of the authors used 3D-printing to make surgical guides, 34% to make anatomic models, 23% to make PSIs, 8% to make occlusal splints and 4% to make epithesis (fig. 4). One article reported custom-made nasoalveolar molding plates used for the treatment of cleft lip and palate
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patients [7]. Some authors used 3D-printing to make several objects such as Steinbacher who reported anatomic models, surgical guides, splints and PSIs [8].
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Among the 100 articles reporting the use of 3D-printed anatomic models, the 2 main indications were mandibular reconstruction (37%) and midface reconstruction (19%). Surgical guides were mainly printed for dental implant placement (39%) and for mandibular reconstruction (24%). Occlusal splints were mainly used in orthognathic surgery (75%). PSIs were mainly used for mandibular reconstruction (38%). Facial epithesis were used in 55% of the cases for middle third face reconstruction and in 27% of the cases for auricular reconstruction.
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Among the 297 articles, 135 (46%) mentioned that the objects were printed by an official MD manufacturer. In the remaining ones, even if the references of the printer and of the material were often given, the exact setting of the printing remained unclear.
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The main advantages reported by the teams using medical 3D-printing were the improvement of precision due to better analysis and planning of the case and to the use of guides and PSI, the possible manipulation of realistic 3D models, the possible repetition of the procedure on the models and the reduction of operating time.
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The main drawbacks were the costs and the production period when printing was done by a professional manufacturer, the need for computing skills, time-consuming planning and regulatory limitations when it was hospital made, and higher infectious risk for PSIs such as skeletal reconstruction parts.
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Discussion
1. Who, worldwide, uses 3D-printing in MFS and is it routine or not?
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Since the first publication of Mankovich et al. in 1990 reporting the possible use of 3D-printing to make anatomic models in MFS [1], a great number of teams have published articles about the clinical use of this technology all around the world. Authors from the People’s Republic of China alone represented 16% of the articles. Our study probably underestimates this use because, by definition, our work only concerns published studies. As this technology tends to become more routine, it is likely that many teams do not publish their cases any more. Our study can therefore not be considered to be perfectly representative of the use of 3D-printing in MFS.
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An enthusiasm for this technique can be noticed starting in 2008 (fig. 1). The number of articles published per year has increased significantly since this date. This clearly coincides with the arrival on the market of low cost 3D-printers. It seems that there has been a stabilization in use since 2015 which may be the sign that 3D-printing applied to MFS is in the process of reaching maturity. Except for anatomic models, all the 3D-printed objects reported in the articles that we analyzed have to be considered as MDs. 51% of the authors came from extra-European countries, not submitted to the restrictive European regulation concerning MDs. This probably explains why many articles do not clearly indicate how, where and by whom the printings were done. Adding up all the patients found in the 297 articles we analyzed, the total number of maxillofacial patients treated by means of a custom-made 3D printed object was 2,889. That is quite a high number, even considering that the same patient case may have been published twice. Concerning the frequency of use, 41% of the articles were single case reports, 74% of the articles concerned 10 or fewer patients. 3D-printing can therefore not be considered as a routine technique for the majority of the publishing MFS teams.
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2. What are the main clinical indications for 3D- printed objects in MFS and, in these indications, what are the kinds of objects that are used?
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The main indications are dental implant surgery, mandibular reconstruction, orthognathic surgery and midface reconstruction. Concerning dental implant surgery, the most printed 3D objects are surgical guides designed to facilitate the orientation and execution of drillings, permitting a correct implant placement, as predicted in preoperative planning. Concerning mandibular reconstruction, the most printed 3D objects are surgical guides. These guides are intended to help the surgeon obtain the correct placement and angulation of the osteotomy lines (cutting guides), insert the screws at predefined places on the model (drilling guide) and position the osteotomized bone segments according to the planning (positioning guide) (fig. 5). Other teams use printed anatomic models in order to practice the procedure preoperatively and to pre-shape the osteosynthesis or reconstruction plates. Some authors report printing PSIs, such as custom-made osteosynthesis plates or anatomically shaped mandibular reconstruction parts. Most of these PSIs are printed in titanium. Concerning orthognathic surgery, authors mainly use printed surgical guides and occlusal splints. Guides are designed to place the osteotomy lines in accordance with the preoperative planning and to avoid anatomical structures such as teeth roots. The drill holes made for the stabilization of the cutting guide are then usually used for the insertion of the osteosynthesis plate screws. Cutting guides are therefore usually also drilling guides. Occlusal splints are used for the positioning of the dental arches in the planned occlusion, considering that a correct occlusion also implies a correct bone segment position.
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On the regulatory level, surgical guides are considered in Europe to be class IIa surgically invasive MDs which penetrate the body through a natural orifice, the mucosa or the skin in the context of a surgical operation, for temporary or short-term use (less than 1 hour or 30-day contact with the human body respectively) and passive (not requiring embodied energy) [9,10]. It should be noted that the software as well as the printers and the materials used for MDs manufacturing are themselves considered to be MDs, belonging to the same class as the MDs they produce, and that they have therefore to follow the same regulatory obligations. Furthermore, the materials used have to follow the ISO 10993-2010 standard of biological evaluation of MDs [11].
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The second most 3D-printed objects are anatomic models intended for a better analysis of skeletal disharmonies and, in some cases, for preoperative training on the model and for pre-shaping/prebending osteosynthesis or reconstruction plates according to the planned outcome (fig. 6). These anatomic models usually never come into contact with the human body and are therefore not considered to be MDs. The manufacturing of these models does not come under any specific regulation. However, the printing process of anatomic models should at least allow for sufficient dimensional precision for surgical applications. This seems to be the case for the majority of 3D printers, including general use printers [12]. Standard osteosynthesis/reconstruction plates (class IIb MDs meaning therapeutic, surgically invasive and long-term use devices) are intended for adaptation to the patient’s anatomy. The preoperative pre-shaping/pre-bending of these plates on an anatomic model does not modify their normal use, does not modify their classification and is therefore allowed without any regulatory limitation. Occlusal splints, that are widely used in orthognathic surgery and that could therefore be considered common, are also class IIa MDs, whatever way they are manufactured, and are consequently subject to the same regulation as surgical guides. The three principal 3D-printed objects reported in literature, surgical guides, occlusal splints and anatomic models, don’t need high biomechanical requirements. They only call on easy-to-use
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materials such as resins, plastics, resorbable polymers, etc., and on very accessible hard- and software technologies. This probably explains their extensive use, sometimes in total illegality (according to the regulation applicable in each country).
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The printing of PSIs, usually made of metal, ceramic or polyether ether ketone, is much more technologically demanding (selective laser sintering, electric beam melting…), and, other than having them made industrially, is almost inaccessible. Most of these PSIs are class IIb MDs (custom-made osteosynthesis plates or skeletal reconstruction parts for example) but some of them (cranioplasty prosthesis, temporo-mandibular joint prosthesis) are class III MDs, the most demanding in terms of requirements (fig. 7,8). The manufacturing of these kinds of MDs, of course, comes under very strict regulation, at least in Europe.
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3D printed facial epithesis are seldom used, mainly in middle third and auricular reconstruction. They have to be considered as class I MDs.
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3. Are these objects printed by an official medical device manufacturer or, on the contrary, made directly within the department itself or within a research lab?
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45% of the articles we analyzed clearly mention that the authors called on an official MD manufacturer. In the others, it is not always clearly mentioned where the printings were done. 73% of the authors who did not outsource printing to an official MD manufacturer made the MD themselves (surgical guide, splint, PSI or epithesis).
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Contrary to what the current easy access to low-cost 3D printers and relatively easy-to-use computer-aided design software allowing for quick and easy MD design might lead to believe, all individuals printing MDs consequently become official MD manufacturers and must as such comply with a complex and constraining bill of specifications [13].
4. What are the reported advantages and drawbacks?
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Most of the authors mention an increase in precision and a reduction of the surgical time even if this has seldom been precisely evaluated or measured. Tarsitano et al. demonstrated that the use of 3D printing enabled their team to obtain a better morphological outcome in mandibular reconstruction [14]. Seruya et al. concluded that microsurgical craniofacial reconstruction using a computer-assisted fibula flap technique yielded significantly shorter ischemia times compared with conventional techniques [15]. Anatomic model printing, which is relatively rapid, simple and inexpensive, may easily be done at the hospital and is not submitted to regulatory limitations. It permits a more detailed analysis of the patient’s anatomy, realistic simulations of surgical procedures and preoperative plate shaping. Surgical guides are usually made by reverse engineering techniques meaning they are designed starting from the planned result. Therefore, these guides contain the necessary information that allows the planning to be transferred to the operating room. They may help guide the bone cuts or the drillings and the positioning of the osteotomized bone segments. The comparison between preoperative planning on virtual models and the real postoperative X-Ray controls was made by several authors and shows that surgical guides permit a gain in precision, whether it is in reconstructive surgery, in orthognathic surgery or in dental implant surgery [16-19]. On the other hand, preoperative planning takes more time, is more complex and needs a certain degree of mastery in computer sciences if done by the surgical team itself. Planning time added to
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printing time may easily take several weeks if given to the industry and may delay surgery, which may be detrimental in case of cancer. In any event, with fast growing tumors, resection margins should always be reevaluated before using the cutting guides. It has to be noted that in some cases, surgeons will have to perform larger approaches due to the bulk of the guides and this may lead to higher morbidity.
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The use of printed occlusal splints enables optimal positioning of bone segments, in accordance with preoperative planning, especially in orthognathic surgery. As for surgical guides, comparison between preoperative planning and postoperative X-Ray control confirm the greater precision of this technique [19,20]. PSIs are nowadays considered to be the nec plus ultra of 3D-printed medical objects.
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Custom-made osteosynthesis plates are designed from the planned result and, as positioning guides, include in their shape information allowing to transfer the planning to the operating room. In this sense, custom-made plates are in competition with navigation techniques. The positioning of the bone segment(s), if cut with the help of the corresponding cutting guide, becomes very easy, as it just has to follow the shape of the plate. Here again, the main advantages are improved precision and a reduction in surgical time as peroperative modelling is no longer necessary.
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Concerning 3D-printed facial skeletal parts, they are mainly obtained from the healthy side by mirroring procedures. Their main advantages are their easy use, and the precision and the predictability of the postoperative results, in particular concerning symmetry. They may even be designed to replace soft tissue losses. Their use may also lower surgical time compared to a free flap reconstruction. The main drawbacks are the risks of exposure and infection even if these complications seem infrequent in the literature. But as efficient and cutting-edge as these PSIs seem to be, it must be noted that their use is still limited, probably because of their costs and because they require collaboration with the industry.
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The main advantages of 3D-printed facial epithesis are that they save time and improve precision, in particular in regards to symmetry, as these epithesis may be designed from the healthy side by mirroring techniques. The computer files of the planning may be preserved in order to make copies later in case of loss or deterioration.
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Concerning the cost of 3D-printing, several studies conclude that the time saved and the improvement in precision that this technology brings could lead to a reduction of global costs if compared to standard methods [21,22]. Moreover, as the market is fast-growing and as in-hospital printing is coming more and more in competition with professional printing, costs will probably decrease in the coming years. As a conclusion, 3D-printing is a relatively recent tool in MFS, particularly in its hospital-made version. Apart from anatomic models, all the other 3D-printed objects are in fact MDs and should therefore follow the regulatory rules in application in most countries. 3D-printed objects seem to reduce surgical time and to improve precision. These benefits should however be evaluated more precisely by comparison with more conventional techniques on larger series. In our experience, the improved precision does not only come from the printed object itself but also from the preoperative planning step that is much more demanding than in conventional techniques. As in all innovative technologies, indisputable indications will progressively emerge as the technique reaches maturity. Comparing industrial and hospital-made 3D-printing, the main advantage of the latter, apart from the cost, is the immediate availability of the technology. This allows for last-minute printings, for the
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printing of “border-line objects”, meaning object that are very close to MDs while not being real MDs (for example, the body of an external fixator), or for the printing of “niche” MDs, meaning devices that are so seldom used that they have become uninteresting to produce by the industry (such as a rib cutting guide or a custom-made healing abutment for a dental implant). The main disadvantages are the regulatory limitations, at least in Europe, the cost of professional 3D-printers designed to print other materials than plastic and resin, the cost of professional software (the free access software being too unpredictable and sometimes time-consuming), and the need for a relatively good understanding of computer sciences.
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Finally, 3D-printed objects should not be considered to be tools for unskilled surgeons. Engineers, as attentive as they might be to surgeons’ needs, are only able to design what they are asked for and must be supervised. Moreover, as nice as a custom-made device looks, it becomes, in some circumstances, impossible to use peroperatively and in those cases, it becomes mandatory for the surgeon to master conventional second choice options.
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[19] Lim SH, Kim MK, Kang SH. Precision of fibula positioning guide in mandibular reconstruction with a fibula graft. Head Face Med 2016;12:1-10. [20] Hammoudeh JA, Howell LK, Boutros S, Scott MA, Urata MM. Current status of surgical planning for orthognathic surgery: traditional methods versus 3D surgical planning. Plast Reconstr Surg Glob Open 2015;3:e307.
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[21] Sun Y, Luebbers HT, Agbaje JO, Schepers S, Vrielinck L, Lambrichts I, et al. Accuracy of upper jaw positioning with intermediate splint fabrication after virtual planning in bimaxillary orthognathic surgery. J Craniofac Surg 2013;24:1871-6. [21] Resnick CM, Inverso G, Wrzosek M, Padwa BL, Kaban LB, Peacock ZS. Is there a difference in cost between standard and virtual surgical planning for orthognathic surgery? J Oral Maxillofac Surg 2016;74:1827-33. [22] Tarsitano A, Battaglia S, Crimi S, Ciocca L, Scotti R, Marchetti C. Is a computer-assisted design and computer-assisted manufacturing method for mandibular reconstruction economically viable? J Craniomaxillofac Surg 2016;44:795-9.
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Figures legends
Figure 1. Number of articles concerning the clinical use of 3D-printng in maxillofacial surgery published per year. For 2007, the count ends June the 1st.
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Figure 2. Number of articles concerning the clinical use of 3D-printng in maxillofacial surgery published per country.
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Figure 3 : Number of articles according to the clinical indication for 3D-printing in maxillofacial surgery.
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Figure 4. Number of articles according to the type of printed object in maxillofacial surgery. Figure 5. Virtual design (left and middle) and aspect (right) of a cutting and drilling guide (Biomet®, Warsaw, IN, USA) intended for the resection of a left temporo-mandibular joint ankylosis block.
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Figure 6. 3D-printed anatomic model of a mandible with virtual planning of a reconstruction by means of a fibular free flap on the right side. Pre-shaping of the osteosynthesis plate (Medartis®, Basel, Switzerland). The plate will be sterilized before use and will help peroperatively not only for the stabilization of the flap but also for the positioning of the osteotomized bone segments.
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Figure 7. Pediatric mandibular reconstruction by means of a rib graft stabilized by mean of custommade osteosynthesis plates (Materialise®, Leuven, Belgium). Top: virtual planning of the reconstruction. Bottom: peroperative view of the graft, the plates and the rib cutting guide.
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Figure 8. Virtual design (left) and peroperative view (right) of a custom-made total temporomandibular joint prosthesis (Biomet®, Warsaw, IN, USA) on the left side for the joint reconstruction after resection of the ankylosis block (same patient then in fig. 5).
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S2468-7855(17)30119-2 http://dx.doi.org/doi:10.1016/j.jormas.2017.07.002 JORMAS 74
To appear in:
Please cite this article as: A. LouvrierP. MartyE. WeberE. EuvrardB. ChatelainA. Barrab´eC. Meyer How useful is 3D printing in maxillo-facial surgery? (2017), http://dx.doi.org/10.1016/j.jormas.2017.07.002 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
How useful is 3D printing in maxillo-facial surgery? Louvrier A1,2,*, Marty P1,2, Weber E1, Euvrard E1,2,3, Chatelain B1, Barrabé A1,2, Meyer C1,2,3 1: Department of Oral and Maxillofacial Surgery, University Hospital of Besançon, Boulevard Fleming, 25030 Besançon Cedex, France. 2: University of Franche-Comté, UFR SMP, 19 Rue Ambroise Paré, 25000 Besançon, France. 3: Nanomedicine Lab, Imagery and Therapeutics, EA 4662, UFR Sciences & Techniques, Université de Franche-Comté, Route de Gray, 25030 Besançon Cedex, France.
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*Corresponding author: [email protected]
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Abstract Introduction: 3D-printing seems to have more and more applications in maxillofacial surgery (MFS), particularly since the release on the market of general use 3D-printers several years ago. The aim of our study was to answer 4 questions: 1. Who uses 3D printing in MFS and is it routine or not? 2. What are the main clinical indications for 3D-printing in MFS and what are the kinds of objects that are used? 3. Are these objects printed by an official medical device (MD) manufacturer or made directly within the department or the lab? 4. What are the advantages and drawbacks?
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Methodology: Two bibliographic researches were conducted on January the 1st, 2017 in PubMed, without time limitation, using “maxillofacial surgery” AND “3D printing” for the first and for the second “maxillofacial surgery” AND “computer-aided design” AND “computer-aided manufacturing” as keywords. Articles in English or French dealing with human clinical use of 3D printing were selected. Publication date, nationality of the authors, number of patients treated, clinical indication(s), type of printed object(s), type of printing (lab/hospital-made or professional/industry) and advantages/drawbacks were recorded.
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Results: 297 articles from 35 countries met the criteria. The most represented country was the People’s Republic of China (16% of the articles). A total of 2,889 patients (10 per article on average) benefited from 3D-printed objects. The most frequent clinical indications were dental implant surgery and mandibular reconstruction. The most frequently printed objects were surgical guides and anatomic models. 45% of the prints were professional. The main advantages were improvement in precision and reduction of surgical time. The main disadvantages were the cost of the objects and the manufacturing period when printed by the industry.
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Discussion: The arrival on the market of low-cost printers has increased the use of 3D-printing in MFS. Anatomic models are not considered to be MDs and do not have to follow any regulation. Nowadays they are easily printed with low-cost printers. They allow for better preoperative planning and training for the procedures and for pre-shaping of plates. Occlusal splints and surgical guides are intended for the smooth transfer of planning to the operating room. They are considered to be MDs and even if they are easy to print, they have to follow the regulations applying to MDs. Patient specific implants (custom-made plates and skeletal reconstruction modules) are much more demanding objects and their manufacturing remains nowadays in the hands of the industry. The main limitation of in-hospital 3D-printing is the restrictive regulations applying to MDs. The main limitations of professional 3D-printing are the cost and the lead time. 3D-printed objects are nowadays easily available in MFS. However, they will never replace a surgeon’s skill and should only be considered as useful tools. Key-words: maxillofacial surgery, 3D printing, computer-aided design, computer-aided manufacturing, review
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Introduction
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The use of 3D printing in maxillofacial surgery (MFS) is not new. It started 30 years ago [1,2] but remained, until recently, in the hands of industry. For about the past ten years of general use, the availability of low cost 3D printers has revived surgeons’ interest in this technology. Applications seem to have become broader and broader, going from simple anatomic models to patient specific implants (PSIs), including cutting or drilling guides. The goal of our study was to evaluate the real interest of 3D printing in MFS by answering 4 questions: 1. Who, worldwide, is using 3D printing in CMFS and is it routine or not? 2. What are the main clinical indications for 3D printed objects in CMFS and, in these indications, what are the type of objects that are used? 3. Are these objects printed by an official medical device manufacturer or, on the contrary, made directly within the department itself or within a research lab? 4. What are the reported advantages and drawbacks?
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Material and methods
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Two bibliographic researches were conducted on January the 1st, 2017 in PubMed, without time limitation, using “maxillofacial surgery” AND “3D printing” as keywords for the first and “maxillofacial surgery” AND “computer-aided design” AND “computer-aided manufacturing” as keywords for the second. Inclusion criteria were human clinical use and French or English as the language of publication. Articles without available on-line abstracts or dealing with 3D printing on a micro- or nanoscale or concerning animal experiments or pure research papers, updates or reviews of the literature were excluded. For each selected article, we underlined the publication date, the nationality of the authors, the number of patients treated, the clinical indication(s), the type of printed object(s), who did the prints (manufacturer or hospital physicians) when this information was available, advantages/drawbacks reported by the authors.
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Results
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From the 1047 articles found on PubMed by using the research strategies, 405 were selected from their abstracts and 297 met all the inclusion criteria after complete reading (fig. 1). The oldest article dated back to 1993 [3] and the most recent to May 2017 [4]. These articles came from 35 different countries (fig. 2). The most represented country was the People’s Republic of China with 16% of the articles. France ranked in 8th position with 4% of the articles.
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The number of patients treated by means of a 3D-printed object varied from 1 to 215 per article with an average of 10 patients. 121 articles (41%) mentioned only 1 patient. The biggest series was about 215 patients and concerned the placement of 362 custom-made temporo-mandibular joint prosthesis [5]. Clinical indications were gathered into 15 categories (fig. 3). Some authors reported several indications in the same article, as did Levine et al. in 2012 (more than 4 categories) [6]. The main indications were dental implant placement and mandibular reconstruction, mainly when using fibula free flaps. 3D-printed objects were classified into 5 categories: anatomic models, surgical (cutting, drilling, positioning) guides, occlusal splints, PSIs (osteosynthesis plates, skeletal reconstruction parts…), facial epithesis. 59% of the authors used 3D-printing to make surgical guides, 34% to make anatomic models, 23% to make PSIs, 8% to make occlusal splints and 4% to make epithesis (fig. 4). One article reported custom-made nasoalveolar molding plates used for the treatment of cleft lip and palate
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patients [7]. Some authors used 3D-printing to make several objects such as Steinbacher who reported anatomic models, surgical guides, splints and PSIs [8].
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Among the 100 articles reporting the use of 3D-printed anatomic models, the 2 main indications were mandibular reconstruction (37%) and midface reconstruction (19%). Surgical guides were mainly printed for dental implant placement (39%) and for mandibular reconstruction (24%). Occlusal splints were mainly used in orthognathic surgery (75%). PSIs were mainly used for mandibular reconstruction (38%). Facial epithesis were used in 55% of the cases for middle third face reconstruction and in 27% of the cases for auricular reconstruction.
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Among the 297 articles, 135 (46%) mentioned that the objects were printed by an official MD manufacturer. In the remaining ones, even if the references of the printer and of the material were often given, the exact setting of the printing remained unclear.
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The main advantages reported by the teams using medical 3D-printing were the improvement of precision due to better analysis and planning of the case and to the use of guides and PSI, the possible manipulation of realistic 3D models, the possible repetition of the procedure on the models and the reduction of operating time.
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The main drawbacks were the costs and the production period when printing was done by a professional manufacturer, the need for computing skills, time-consuming planning and regulatory limitations when it was hospital made, and higher infectious risk for PSIs such as skeletal reconstruction parts.
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Discussion
1. Who, worldwide, uses 3D-printing in MFS and is it routine or not?
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Since the first publication of Mankovich et al. in 1990 reporting the possible use of 3D-printing to make anatomic models in MFS [1], a great number of teams have published articles about the clinical use of this technology all around the world. Authors from the People’s Republic of China alone represented 16% of the articles. Our study probably underestimates this use because, by definition, our work only concerns published studies. As this technology tends to become more routine, it is likely that many teams do not publish their cases any more. Our study can therefore not be considered to be perfectly representative of the use of 3D-printing in MFS.
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An enthusiasm for this technique can be noticed starting in 2008 (fig. 1). The number of articles published per year has increased significantly since this date. This clearly coincides with the arrival on the market of low cost 3D-printers. It seems that there has been a stabilization in use since 2015 which may be the sign that 3D-printing applied to MFS is in the process of reaching maturity. Except for anatomic models, all the 3D-printed objects reported in the articles that we analyzed have to be considered as MDs. 51% of the authors came from extra-European countries, not submitted to the restrictive European regulation concerning MDs. This probably explains why many articles do not clearly indicate how, where and by whom the printings were done. Adding up all the patients found in the 297 articles we analyzed, the total number of maxillofacial patients treated by means of a custom-made 3D printed object was 2,889. That is quite a high number, even considering that the same patient case may have been published twice. Concerning the frequency of use, 41% of the articles were single case reports, 74% of the articles concerned 10 or fewer patients. 3D-printing can therefore not be considered as a routine technique for the majority of the publishing MFS teams.
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2. What are the main clinical indications for 3D- printed objects in MFS and, in these indications, what are the kinds of objects that are used?
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The main indications are dental implant surgery, mandibular reconstruction, orthognathic surgery and midface reconstruction. Concerning dental implant surgery, the most printed 3D objects are surgical guides designed to facilitate the orientation and execution of drillings, permitting a correct implant placement, as predicted in preoperative planning. Concerning mandibular reconstruction, the most printed 3D objects are surgical guides. These guides are intended to help the surgeon obtain the correct placement and angulation of the osteotomy lines (cutting guides), insert the screws at predefined places on the model (drilling guide) and position the osteotomized bone segments according to the planning (positioning guide) (fig. 5). Other teams use printed anatomic models in order to practice the procedure preoperatively and to pre-shape the osteosynthesis or reconstruction plates. Some authors report printing PSIs, such as custom-made osteosynthesis plates or anatomically shaped mandibular reconstruction parts. Most of these PSIs are printed in titanium. Concerning orthognathic surgery, authors mainly use printed surgical guides and occlusal splints. Guides are designed to place the osteotomy lines in accordance with the preoperative planning and to avoid anatomical structures such as teeth roots. The drill holes made for the stabilization of the cutting guide are then usually used for the insertion of the osteosynthesis plate screws. Cutting guides are therefore usually also drilling guides. Occlusal splints are used for the positioning of the dental arches in the planned occlusion, considering that a correct occlusion also implies a correct bone segment position.
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On the regulatory level, surgical guides are considered in Europe to be class IIa surgically invasive MDs which penetrate the body through a natural orifice, the mucosa or the skin in the context of a surgical operation, for temporary or short-term use (less than 1 hour or 30-day contact with the human body respectively) and passive (not requiring embodied energy) [9,10]. It should be noted that the software as well as the printers and the materials used for MDs manufacturing are themselves considered to be MDs, belonging to the same class as the MDs they produce, and that they have therefore to follow the same regulatory obligations. Furthermore, the materials used have to follow the ISO 10993-2010 standard of biological evaluation of MDs [11].
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The second most 3D-printed objects are anatomic models intended for a better analysis of skeletal disharmonies and, in some cases, for preoperative training on the model and for pre-shaping/prebending osteosynthesis or reconstruction plates according to the planned outcome (fig. 6). These anatomic models usually never come into contact with the human body and are therefore not considered to be MDs. The manufacturing of these models does not come under any specific regulation. However, the printing process of anatomic models should at least allow for sufficient dimensional precision for surgical applications. This seems to be the case for the majority of 3D printers, including general use printers [12]. Standard osteosynthesis/reconstruction plates (class IIb MDs meaning therapeutic, surgically invasive and long-term use devices) are intended for adaptation to the patient’s anatomy. The preoperative pre-shaping/pre-bending of these plates on an anatomic model does not modify their normal use, does not modify their classification and is therefore allowed without any regulatory limitation. Occlusal splints, that are widely used in orthognathic surgery and that could therefore be considered common, are also class IIa MDs, whatever way they are manufactured, and are consequently subject to the same regulation as surgical guides. The three principal 3D-printed objects reported in literature, surgical guides, occlusal splints and anatomic models, don’t need high biomechanical requirements. They only call on easy-to-use
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materials such as resins, plastics, resorbable polymers, etc., and on very accessible hard- and software technologies. This probably explains their extensive use, sometimes in total illegality (according to the regulation applicable in each country).
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The printing of PSIs, usually made of metal, ceramic or polyether ether ketone, is much more technologically demanding (selective laser sintering, electric beam melting…), and, other than having them made industrially, is almost inaccessible. Most of these PSIs are class IIb MDs (custom-made osteosynthesis plates or skeletal reconstruction parts for example) but some of them (cranioplasty prosthesis, temporo-mandibular joint prosthesis) are class III MDs, the most demanding in terms of requirements (fig. 7,8). The manufacturing of these kinds of MDs, of course, comes under very strict regulation, at least in Europe.
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3D printed facial epithesis are seldom used, mainly in middle third and auricular reconstruction. They have to be considered as class I MDs.
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3. Are these objects printed by an official medical device manufacturer or, on the contrary, made directly within the department itself or within a research lab?
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45% of the articles we analyzed clearly mention that the authors called on an official MD manufacturer. In the others, it is not always clearly mentioned where the printings were done. 73% of the authors who did not outsource printing to an official MD manufacturer made the MD themselves (surgical guide, splint, PSI or epithesis).
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Contrary to what the current easy access to low-cost 3D printers and relatively easy-to-use computer-aided design software allowing for quick and easy MD design might lead to believe, all individuals printing MDs consequently become official MD manufacturers and must as such comply with a complex and constraining bill of specifications [13].
4. What are the reported advantages and drawbacks?
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Most of the authors mention an increase in precision and a reduction of the surgical time even if this has seldom been precisely evaluated or measured. Tarsitano et al. demonstrated that the use of 3D printing enabled their team to obtain a better morphological outcome in mandibular reconstruction [14]. Seruya et al. concluded that microsurgical craniofacial reconstruction using a computer-assisted fibula flap technique yielded significantly shorter ischemia times compared with conventional techniques [15]. Anatomic model printing, which is relatively rapid, simple and inexpensive, may easily be done at the hospital and is not submitted to regulatory limitations. It permits a more detailed analysis of the patient’s anatomy, realistic simulations of surgical procedures and preoperative plate shaping. Surgical guides are usually made by reverse engineering techniques meaning they are designed starting from the planned result. Therefore, these guides contain the necessary information that allows the planning to be transferred to the operating room. They may help guide the bone cuts or the drillings and the positioning of the osteotomized bone segments. The comparison between preoperative planning on virtual models and the real postoperative X-Ray controls was made by several authors and shows that surgical guides permit a gain in precision, whether it is in reconstructive surgery, in orthognathic surgery or in dental implant surgery [16-19]. On the other hand, preoperative planning takes more time, is more complex and needs a certain degree of mastery in computer sciences if done by the surgical team itself. Planning time added to
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printing time may easily take several weeks if given to the industry and may delay surgery, which may be detrimental in case of cancer. In any event, with fast growing tumors, resection margins should always be reevaluated before using the cutting guides. It has to be noted that in some cases, surgeons will have to perform larger approaches due to the bulk of the guides and this may lead to higher morbidity.
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The use of printed occlusal splints enables optimal positioning of bone segments, in accordance with preoperative planning, especially in orthognathic surgery. As for surgical guides, comparison between preoperative planning and postoperative X-Ray control confirm the greater precision of this technique [19,20]. PSIs are nowadays considered to be the nec plus ultra of 3D-printed medical objects.
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Custom-made osteosynthesis plates are designed from the planned result and, as positioning guides, include in their shape information allowing to transfer the planning to the operating room. In this sense, custom-made plates are in competition with navigation techniques. The positioning of the bone segment(s), if cut with the help of the corresponding cutting guide, becomes very easy, as it just has to follow the shape of the plate. Here again, the main advantages are improved precision and a reduction in surgical time as peroperative modelling is no longer necessary.
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Concerning 3D-printed facial skeletal parts, they are mainly obtained from the healthy side by mirroring procedures. Their main advantages are their easy use, and the precision and the predictability of the postoperative results, in particular concerning symmetry. They may even be designed to replace soft tissue losses. Their use may also lower surgical time compared to a free flap reconstruction. The main drawbacks are the risks of exposure and infection even if these complications seem infrequent in the literature. But as efficient and cutting-edge as these PSIs seem to be, it must be noted that their use is still limited, probably because of their costs and because they require collaboration with the industry.
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The main advantages of 3D-printed facial epithesis are that they save time and improve precision, in particular in regards to symmetry, as these epithesis may be designed from the healthy side by mirroring techniques. The computer files of the planning may be preserved in order to make copies later in case of loss or deterioration.
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Concerning the cost of 3D-printing, several studies conclude that the time saved and the improvement in precision that this technology brings could lead to a reduction of global costs if compared to standard methods [21,22]. Moreover, as the market is fast-growing and as in-hospital printing is coming more and more in competition with professional printing, costs will probably decrease in the coming years. As a conclusion, 3D-printing is a relatively recent tool in MFS, particularly in its hospital-made version. Apart from anatomic models, all the other 3D-printed objects are in fact MDs and should therefore follow the regulatory rules in application in most countries. 3D-printed objects seem to reduce surgical time and to improve precision. These benefits should however be evaluated more precisely by comparison with more conventional techniques on larger series. In our experience, the improved precision does not only come from the printed object itself but also from the preoperative planning step that is much more demanding than in conventional techniques. As in all innovative technologies, indisputable indications will progressively emerge as the technique reaches maturity. Comparing industrial and hospital-made 3D-printing, the main advantage of the latter, apart from the cost, is the immediate availability of the technology. This allows for last-minute printings, for the
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printing of “border-line objects”, meaning object that are very close to MDs while not being real MDs (for example, the body of an external fixator), or for the printing of “niche” MDs, meaning devices that are so seldom used that they have become uninteresting to produce by the industry (such as a rib cutting guide or a custom-made healing abutment for a dental implant). The main disadvantages are the regulatory limitations, at least in Europe, the cost of professional 3D-printers designed to print other materials than plastic and resin, the cost of professional software (the free access software being too unpredictable and sometimes time-consuming), and the need for a relatively good understanding of computer sciences.
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Finally, 3D-printed objects should not be considered to be tools for unskilled surgeons. Engineers, as attentive as they might be to surgeons’ needs, are only able to design what they are asked for and must be supervised. Moreover, as nice as a custom-made device looks, it becomes, in some circumstances, impossible to use peroperatively and in those cases, it becomes mandatory for the surgeon to master conventional second choice options.
Bibliography
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[2] Stoker NG, Mankovich NJ, Valentino D. Stereolithographic models for surgical planning: preliminary report. J Oral Maxillofac Surg 1992;50:466-71. [3] Takato T, Harii K, Hirabayashi S, Komuro Y, Yonehara Y, Susami T. Mandibular lengthening by gradual distraction: analysis using accurate skull replicas. Br J Plast Surg 1993;46:686-93.
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[4] Pinto I, Pinhão Ferreira A, Figueiredo AA. How to achieve facial balance by mandibular contouring ostectomy in hemimandibular hyperplasia. J Craniofac Surg 2017;31. doi: 10.1097/SCS.0000000000003685
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[5] Mercuri LG, Wolford LM, Sanders B, White RD, Hurder A, Henderson W. Custom CAD/CAM total temporomandibular joint reconstruction system: preliminary multicenter report. J Oral Maxillofac Surg 1995;53:106-16. [6] Levine JP, Patel A, Saadeh PB, Hirsch DL. Computer-aided design and manufacturing in craniomaxillofacial surgery: the new state of the art. J Craniofac Surg 2012;23:288-93.
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[7] Ritschl LM, Rau A, Güll FD, diBora B, Wolff KD, Schönberger M, et al. Pitfalls and solutions in virtual design of nasoalveolar molding plates by using CAD/CAM technology. A preliminary clinical study. J Craniomaxillofac Surg 2016;44:453-9. [8] Steinbacher DM. Three-dimensional analysis and surgical planning in craniomaxillofacial surgery. J Oral Maxillofac Surg 2015;73:S40-56. [9] Parlement et Conseil européen. Directive 93/42/CEE relative aux dispositifs médicaux, modifiée par les directives 98/79/ CEE, 200/70/CEE, 2001/104/CEE et 2007/47/CEE et par le règlement CE n° 1882/2003. http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:FR:PDF [10] http://www.qualitiso.com/modifications-classification-dm-reglement-europeen/
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[11] AFNOR. NF en ISO 10993:2010. Evaluation biologique des dispositifs médicaux. www.boutique.afnor.org/norme/nf-en-iso-14971/evaluation-biologique-des-dispositifs-medicauxpartie-1-evaluation-et-essais-au-sein-d-un- processus-de-gestion-du-risque/article/695014/fa14917b [en ligne, parution 07/2010]. [12] Salmi M, Paloheimo KS, Tuomi J, Wolff J, Mäkitie A. Accuracy of medical models made by additive manufacturing (rapid manufacturing). J Craniomaxillofac Surg 2013;41:603-9.
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[15] Seruya M, Fisher M, Rodriguez ED. Computer-assisted versus conventional free fibula flap technique for craniofacial reconstruction: an outcomes comparison. Plast Reconstr Surg 2013;132:1219-28.
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[16] Mazzoni S, Bianchi A, Schiariti G, Badiali G, Marchetti C. Computer-aided design and computeraided manufacturing cutting guides and customized titanium plates are useful in upper maxilla waferless repositioning. J Oral Maxillofac Surg 2015;73:701-7.
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[17] Bosc R, Hersant B, Carloni R, Niddam J, Bouhassira J, De Kermadec H, et al. Mandibular reconstruction after cancer: an in-house approach to manufacturing cutting guides. Int J Oral Maxillofac Surg 2017;46:24-31.
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[18] Du-Hyeong L, Seo-Young A, Min-Ho H, Kyoung-Bae J, Kyu-Bok L. Accuracy of a direct drill-guiding system with minimal tolerance of surgical instruments used for implant surgery: a prospective clinical study. J Adv Prosthodont 2016;8:207–13.
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[19] Lim SH, Kim MK, Kang SH. Precision of fibula positioning guide in mandibular reconstruction with a fibula graft. Head Face Med 2016;12:1-10. [20] Hammoudeh JA, Howell LK, Boutros S, Scott MA, Urata MM. Current status of surgical planning for orthognathic surgery: traditional methods versus 3D surgical planning. Plast Reconstr Surg Glob Open 2015;3:e307.
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[21] Sun Y, Luebbers HT, Agbaje JO, Schepers S, Vrielinck L, Lambrichts I, et al. Accuracy of upper jaw positioning with intermediate splint fabrication after virtual planning in bimaxillary orthognathic surgery. J Craniofac Surg 2013;24:1871-6. [21] Resnick CM, Inverso G, Wrzosek M, Padwa BL, Kaban LB, Peacock ZS. Is there a difference in cost between standard and virtual surgical planning for orthognathic surgery? J Oral Maxillofac Surg 2016;74:1827-33. [22] Tarsitano A, Battaglia S, Crimi S, Ciocca L, Scotti R, Marchetti C. Is a computer-assisted design and computer-assisted manufacturing method for mandibular reconstruction economically viable? J Craniomaxillofac Surg 2016;44:795-9.
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Figures legends
Figure 1. Number of articles concerning the clinical use of 3D-printng in maxillofacial surgery published per year. For 2007, the count ends June the 1st.
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Figure 2. Number of articles concerning the clinical use of 3D-printng in maxillofacial surgery published per country.
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Figure 3 : Number of articles according to the clinical indication for 3D-printing in maxillofacial surgery.
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Figure 4. Number of articles according to the type of printed object in maxillofacial surgery. Figure 5. Virtual design (left and middle) and aspect (right) of a cutting and drilling guide (Biomet®, Warsaw, IN, USA) intended for the resection of a left temporo-mandibular joint ankylosis block.
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Figure 6. 3D-printed anatomic model of a mandible with virtual planning of a reconstruction by means of a fibular free flap on the right side. Pre-shaping of the osteosynthesis plate (Medartis®, Basel, Switzerland). The plate will be sterilized before use and will help peroperatively not only for the stabilization of the flap but also for the positioning of the osteotomized bone segments.
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Figure 7. Pediatric mandibular reconstruction by means of a rib graft stabilized by mean of custommade osteosynthesis plates (Materialise®, Leuven, Belgium). Top: virtual planning of the reconstruction. Bottom: peroperative view of the graft, the plates and the rib cutting guide.
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Figure 8. Virtual design (left) and peroperative view (right) of a custom-made total temporomandibular joint prosthesis (Biomet®, Warsaw, IN, USA) on the left side for the joint reconstruction after resection of the ankylosis block (same patient then in fig. 5).
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