Accuracy of intraoral real-time navigation versus static, CAD/CAM-manufactured pilot drilling guides in dental implant surgery: an in vitro study.

BACKGROUND: Nowadays, 3D planning and static for dynamic aids play an increasing role in oral rehabilitation of the masticatory apparatus with dental implants. The aim of this study is to compare the accuracy of implant placement using a 3D-printed drilling guide and an intraoral real-time dynamic navigation system. METHODS: A total of 60 implants were placed on 12 partially edentulous lower jaw models. 30 were placed with pilot drilling guides, the other half with dynamic navigation (DENACAM®). In addition, implant placement in interdental gaps and free-end situations were investigated. Accuracy was assessed by cone-beam computed tomography (CBCT). RESULTS: Both systems achieved clinically acceptable results, yet more accurate results regarding the offset of implant base and tip in several spatial dimensions were achieved using drilling guides (each p < 0.05). With regard to angulation, real-time navigation was more precise (p = 0.0016). Its inaccuracy was 3°; the template-guided systems was 4.6°. Median horizontal deviation was 0.52 mm at base and 0.75 mm at tip using DENACAM®. When using the pilot drill guide, horizontal deviation was 0.34 mm in the median and at the tip by 0.59 mm. Regarding angulation, it was found that the closer the drill hole was to the system's marker, the better navigation performed. The template did not show this trend (p = 0.0043; and p = 0.0022). CONCLUSION: Considering the limitations of an in vitro study, dynamic navigation can be used be a tool for reliable and accurate implantation. However, further clinical studies need to follow in order to provide an evidence-based recommendation for use in vivo.

Prelamination of the Radial Forearm Free Flap Using Free Full-Thickness Eyelid Skin Grafts: A New Approach for Intraoral Defect Reconstruction.

ABSTRACT: Free flap transfer for reconstruction of intraoral defects is a common procedure in oral and maxillofacial surgery. For tumor-related defects, the radial forearm flap is widely used for soft tissue restoration. However, transfer of free skin grafts to the donor site region is often required for wound closure after free flap harvesting, resulting in esthetic disturbances due to shrinkage of the grafted skin, attendant scarring, or mismatches in skin texture or color. Furthermore, free flap transfer may result in hair follicle transfer into the oral cavity, causing unfavorable intraoral hair growth in adult men in particular. Free flap prelamination can help reduce the potential disadvantages of free flaps, in terms of both flap design and size and donor site morbidity. For surgical treatment of oral cancer in middle-aged and elderly patients, eyelid dermatochalasis may present as a comorbidity leading to esthetic impairments or, in cases involving the upper eyelid, even a reduced field of view. In these cases, bilateral blepharoplasty can reduce the excess eyelid skin. The present study is the first to attempt to use excised skin after bilateral blepharoplasty as full-thickness skin grafts for radial forearm free flap prelamination. This approach combined surgical therapy of eyelid dermatochalasis with free flap prelamination, thereby avoiding the need to harvest free skin grafts from other anatomically healthy regions to close the donor site defect and preventing the accompanying disadvantages. The reconstruction results and clinical outcomes of patients revealed that radial forearm free flap prelamination using bilateral free full-thickness eyelid skin grafts was an easy and feasible method for intraoral defect reconstruction. In particular, this approach could avoid intraoral hair growth and additional skin grafting from other healthy anatomical regions, yielding good esthetic and functional results at the flap's recipient and donor sites.

Novel approach for treating challenging implant-borne maxillary dental rehabilitation cases of cleft lip and palate: a retrospective study.

PURPOSE: Dental restoration in cleft lip and palate (CLP) patients is demanding and often results in bone loss and dental implant failure. Furthermore, unfavorable conditions of hard and soft tissues as well as skeletal deformities aggravate surgical and dental treatment. Therefore, this study was designed to assess the feasibility of using a new type of patient-specific implant (IPS-preprosthetic®) in CLP patients. METHODS: Of the 63 patients who received a IPS-preprosthetic® implant in the Department of Oral and Maxillofacial Surgery at the Hannover Medical School, Germany, six patients were treated for a CLP deformity with significant soft and hard tissue impairment. Two patients were partially edentulous, whereas four patients were edentulous for the maxilla. All implants were inserted in a single-step outpatient surgery and were followed up for up to 40 months. RESULTS: Within the observation period, no implant failed and no screw loosening or change in stability of the implant to recipient site occurred (mean number of screws: 21). This study demonstrates, for the first time, the efficient use of a one-piece multivector screw primarily retained a stable patient-specific implant for implant-borne prosthodontic rehabilitation of CLP patients with deformities and challenging initial situations. CONCLUSIONS: IPS-preprosthetic® implants offer a novel approach to implant dentistry treatment protocols, especially in difficult cases of unusual anatomy, even when previous conventional treatment fails.

Gender-specific differences concerning psychosocial aspects and functional impairments that influence quality of life in oral cancer treatment.

PURPOSE: Patients with oral cancer have gender-specific differences with respect to health-related quality of life (HRQoL) and psychosocial variables (PV). The aim of the present study was to evaluate HRQoL and PV outcomes in patients treated for oral squamous cell carcinoma. METHODS: Data of 1234 patients were collected from a multicenter rehabilitation study of the German-Austrian-Swiss Cooperative Group on Tumours of the Maxillofacial Region (DÖSAK). Patient characteristics, oncological variables, post-treatment impairments, general quality of life (QoL), and PV (coping strategies, control beliefs, personal traits, perceived social support, depression, anxiety, and fear of tumor recurrence) were recorded. RESULTS: After treatment, HRQoL was similar between genders concerning general QoL, but men experienced significantly more treatment-related functional impairments influencing HRQoL. PV revealed gender-specific coping strategies, with women reporting significantly more "depressive coping," "religiosity," "fatalistic externality," and higher "social burden." Owing to their religious coping strategies, fatalistic attitude, and perceived higher social integration, women demonstrated superior disease acceptance, despite higher depression, anxiety, and lower psychosocial resilience. Conversely, men reported more introverted personal traits and lower social integration. CONCLUSION: Interventions during oral cancer treatment should address PV and have gender-specific elements to improve HRQoL after therapy.

Postoperative quality of life and therapy-related impairments of oral cancer in relation to time-distance since treatment.

PURPOSE: Oral cancer resection can cause physical and psychological impairments that influence the quality of life (QoL). Depending on the postoperative time-distance, the occurrence and intensity of these impairments may change. We evaluated the sequelae and changes in therapy-related impairments during the postoperative course to detect associations between the time since surgery and the presence of disorders. METHODS: Data from a questionnaire completed by 1359 patients who underwent surgical treatment of oral squamous cell carcinoma and were involved in a multicenter rehabilitation study of the German-Austrian-Swiss Cooperative Group on Tumors of the Maxillofacial Region (DÖSAK) that included 43 oral and maxillofacial clinics in Germany, Austria, and Switzerland were retrospectively analyzed. RESULTS: Physical impairments, including those in appearance, mouth opening ability, ability to smell, gastric disorders, mandible mobility, breathing, and shoulder/arm mobility, were significantly associated with and increased with time-distance since surgery. Esthetic appearance most strongly correlated with the highest perception of worsening. Regarding psychological disorders, worry about tumor recurrence, depression, and worse prospects were significantly associated. Among the postoperative sequelae, fear of tumor recurrence decreased continuously; however, depression and worse prospects increased. The general QoL did not significantly differ overall during the postoperative course. CONCLUSIONS: Therapy-related impairments change during the postoperative course based on the time-distance since surgery. The general QoL may not markedly vary; however, single impairments, to some extent, can increase or decrease. IMPLICATIONS FOR CANCER SURVIVORS: Continuous adaptation of supportive cancer therapy is required during follow-up to sufficiently address individual treatment needs.

Managing the severely atrophic maxilla: Farewell to zygomatic implants and extensive augmentations?

BACKGROUND: Dental rehabilitation of severe atrophic upper jaws remains challenging. A new generation of subperiosteally placed and rigid multi-vector bone-anchored patient-specific implants proposes an innovative line extension in implant dentistry. This single-center retrospective study focused on treating severely atrophic maxillae using these implants. METHODS: All patients who were treated with a patient-specific implant (IPS Implant® Preprosthetic, KLS-Martin, Tuttlingen, Germany) at Hannover Medical School due to severe atrophy of the maxilla who had no history of malignancy, cleft lip or palate, or trauma were evaluated regarding implant stability and prosthetic restoration, as well as complications. RESULTS: Out of a total of 58 inserted implants, 13 implants in 10 patients, which were placed to treat a severely atrophic upper jaw, were identified. The mean follow-up period was 8.2 months (1-29 months). All implants were clinically stable over the entire period. All patients with an observation period of over 2 months received prosthetics for restoration. Minor complications, screw fractures, infection, and exposure of the framework were observed, but these did not lead to failure. CONCLUSION: This initial follow-up suggests that this new generation of implants represents a valuable treatment alternative, especially for patients with a history of failed dental implant placement. Larger numbers of cases and longer observation periods are required to confirm our findings.

Endoscopically Assisted Treatment of Condylar Base and Neck Fractures: A Single Institution Analysis of Outcomes and Complications.

BACKGROUND: Conservative treatment, including observation and closed treatment, as well as open reduction and internal fixation are existing options for treating condylar process fractures. Extraoral approaches are widely preferred for open reduction and internal fixation. Transoral access for condylar base and neck fractures is not yet commonly used as it is technically demanding and requires special equipment. PURPOSE: In this study, the transoral endoscopically assisted approach is described, and its outcomes and complications were investigated. Imaging data and clinical records of 187 patients with condylar process fractures, treated via endoscopically assisted transoral approach between 2007 and 2017 were analyzed. Parameters included diagnosis and fracture classification, treatment, osteosynthesis configuration and postoperative complications. RESULTS: Early complications, including infection, transient postoperative malocclusion, pain and limited mouth opening, occurred in 35 patients (18.7%). Late onset complications, such as screw loosening were documented in only 4 patients (2.1%). Revision surgery following postoperative 3D imaging was required in only 3 cases (1.6%). Fragment length ranged from 15.5 to 38.3 mm. In 57.7% of patients with condylar fragment length < 20 mm, a single osteosynthesis plate was used, with no elevated complication rate. Two osteosynthesis plates with 4 screws each was used as standard in longer fragments. CONCLUSION: Endoscopically assisted transoral treatment of condylar process fractures is a reliable, yet technical demanding technique. It allows for reduction and fixation of fractures with a condylar fragment length of > 15 mm with low postoperative complication and revision rates.

[Complex reconstructions in the facial and cranial regions]. / Komplexe Rekonstruktionen im Gesichts- und im Schädelbereich.

Posttraumatic reconstruction of the neurocranium and viscerocranium is an essential part of modern oral and maxillofacial surgery, in addition to oncological surgery, surgery of congenital craniofacial deformities and dental surgery. Due to the complex anatomy of the facial skull and significant esthetic and functional demands on its reconstruction, reconstructive trauma surgery in this area places the highest demands on the surgeon. This is all the more true if definitive craniomaxillofacial surgical treatment can sometimes only be performed with considerable delays for the benefit of other life-threatening injuries. In order to take these prerequisites into account, achievements of modern biomedical technology, such as intraoperative real-time navigation, computer-assisted planning and computer-assisted manufacturing (CAD/CAM) of patient-specific biomodels and implants, came up early for use in oral and maxillofacial surgery. In combination with intraoperative three-dimensional imaging, these methods result in a treatment pathway tailored to the individual patient, which is directly checked for quality at every step and thus ensures the best possible result for the patient. The use of these technologies extends far beyond the original indications in the area of orbital reconstruction and restoration of bony defects with simple geometry, such as skull defects. Nowadays, even the most complex pan-facial fractures can be restored esthetically and functionally by means of digitalized preliminary planning and individualized skull, orbital and zygomatic implants as well as total temporomandibular joint prostheses.

Accuracy of Guided Surgery and Real-Time Navigation in Temporomandibular Joint Replacement Surgery.

BACKGROUND: Sophisticated guided surgery has not been implemented into total joint replacement-surgery (TJR) of the temporomandibular joint (TMJ) so far. Design and in-house manufacturing of a new advanced drilling guide with vector and length control for a typical TJR fossa component are described in this in vitro study, and its accuracy/utilization was evaluated and compared with those of intraoperative real-time navigation and already available standard drilling guides. METHODS: Skull base segmentations of five CT-datasets from different patients were used to design drilling guides with vector and length control according to virtual surgical planning (VSP) for the TJR of the TMJ. Stereolithographic models of the skull bases were printed three times for each case. Three groups were formed to compare our newly designed advanced drilling guide with a standard drilling guide and drill-tracking by real-time navigation. The deviation of screw head position, screw length and vector in the lateral skull base have been evaluated (n = 72). RESULTS: There was no difference in the screw head position between all three groups. The deviation of vector and length was significantly lower with the use of the advanced drilling guide compared with standard guide and navigation. However, no benefit in terms of accuracy on the lateral skull base by the use of real-time navigation could be observed. CONCLUSION: Since guided surgery is standard in implant dentistry and other CMF reconstructions, this new approach can be introduced into clinical practice soon, in order to increase accuracy and patient safety.

Changes in Emergency Patient Presentation to a Maxillofacial Surgery Department During the COVID-19 Pandemic.

PURPOSE: To examine possible changes in the emergency patient volume and reasons for presentation to an oral and maxillofacial surgery department during the coronavirus disease 2019 (COVID-19) pandemic and the resulting contact prohibitions. We hypothesized that the pandemic would lead to fewer patients presenting with emergent conditions. METHODS: A total of 939 patients, who presented to the Department for Oral and Maxillofacial Surgery of Hannover Medical School during the first 4 weeks of contact prohibitions in Germany, starting from March 23, 2020 until April 19, 2020, and in comparable periods were examined. The number of patients, reason for presentation, and required treatments were documented and compared to the years 2018 and 2019. Special attention was paid to the changes in trauma cases. RESULTS: We found that the number of patients in 2020 was significantly lower (P(2019) < .001, P(2018) < .01), but sex and age distributions were comparable to those in the previous years. Both the absolute and relative frequencies of dental diagnoses were significantly lower in 2020 (P(2019) < .001, P(2018) < .001), while the proportion of patients who presented with trauma was significantly higher (P(2019) < .001, P(2018) < .001). A significant decrease in patient number to the hospital, despite private practices being closed, was presumably due to patients' infection-related concerns. Trauma cases were more frequent in private settings, and traumatic events under the influence of alcohol were frequent. The circumstances and not the absolute number of trauma events had changed. CONCLUSIONS: The results of this study suggest that the COVID-19 pandemic has important effects on the use of emergency services concerning oral and maxillofacial surgery in Germany.

CAD/CAM-based referencing aids to reduce preoperative radiation exposure for intraoperative navigation.

BACKGROUND: All intraoperative navigation systems need a referencing procedure prior to utilization, usually requiring an additional computed tomography (CT) or cone beam computed tomograph (CBCT) scan. As new techniques in the field of Computer-aided design / Computer-aided manufacturing (CAD/CAM) have evolved, it seemed favourable to develop a new referencing method not relying on additional CT or CBCT scans. METHODS: A digital maxillary dental scan was used to create a referencing splint by CAD/CAM containing four reference points. By matching scanned dental model and initial trauma-CT, the splints position and thus the reference points were digitally simulated. These splints data were imported into the navigation system in Standard Tessellation Language (STL) format. These data were also 3D printed and the resulting piece was placed on the anatomical models' teeth. The methods accuracy was then assessed in vitro. CONCLUSION: Our method for referencing of intraoperative navigation can be feasible to avoid an additional CT or CBCT prior to navigation.

Self-centering second-generation patient-specific functionalized implants for deep orbital reconstruction.

Deep and complete reconstruction of the orbital cavity has been shown to be essential for preventing enophthalmos and hypoglobus in patients with orbital defects or deformities. Additively manufactured patient-specific titanium implants provide unlimited options in design. However, implant malpositioning can still occur, even when intraoperative imaging and navigation are used. In this study, we investigated novel orbital implants containing features facilitating self-centering. Accuracy of implant placement and reconstruction of the orbital dimensions were compared retrospectively between self-centering second-generation patient-specific functionalized orbital implants (study group) and CAD-based individualized implants (control group). Design features of implants in the study group included functionalization with navigation tracks, a preventive design, and flanges - so called stabilizers - towards opposite orbital walls. Implant position was evaluated by fusion of preoperative virtual plans and the post-therapeutic imaging. Aberrances were quantified by 3D heatmap analysis. 31 patients were assigned to the study group and 50 to the control group, respectively. In the study group, most implants were designed with either one (n = 18, 58.06%) or two (n = 10, 32.26%) stabilizers. Twice (6.45%), one stabilizer had to be shortened intraoperatively. Implant fit analysis revealed a significantly more precise (p < 0.001) positioning in the study group (n = 22/31) than in the control group (n = 42/50). Self-centering second-generation patient-specific functionalized orbital implants showed significantly more accurate implant positioning, facilitating the transformation of virtual plans into patient's anatomy. The presented design provides an additional instrument for intraoperative quality control besides intraoperative imaging and navigation.

Fulfillment of patients' information needs during oral cancer treatment and its association with posttherapeutic quality of life.

PURPOSE: Surgical therapy for oral cancer can lead to severe physical and psychological disorders that negatively impact patient quality of life (QoL). This study aimed to evaluate the relationship between fulfillment of patients' information needs during oral cancer treatment and patients' perception of posttherapeutic disorders influencing QoL. METHODS: A retrospective analysis of 1359 patients who were surgically treated for oral cancer using questionnaires administered during the multicenter rehabilitation study by the German-Austrian-Swiss Cooperative Group on Tumors of the Maxillofacial Region (DÖSAK). Patients and medical practitioners completed questionnaires following cancer treatment. RESULTS: Approximately 37% of patients felt inadequately informed about possible physical and psychological consequences of surgery. In contrast, only 16% of patients felt they were given inadequate information about the operative procedure and possible complications, and with regard to tumor diagnosis and cancer disease, only 15% of patients. Significant correlations were found between lacking information and increased perception of posttherapeutic disorders, whereas correlations with tumor-specific and operation-related parameters were markedly lower. The patients with superior QoL after treatment stated more frequently, nearly independent of individual patient characteristics, that the information that they were given prior to therapy was adequate. Information concerning possible physical and psychological consequences of an operation, however, was frequently stated to be inadequate, independent of QoL. CONCLUSION: Patients whose information needs concerning the diagnosis and treatment of oral cancer are adequately fulfilled may benefit in terms of their therapeutic outcome, experiencing less perception of posttherapeutic physical and psychological disorders and a superior QoL.

Influence of Unilateral Cleft Lip Configuration on Long-Term Facial Averageness: A New Three-Dimensional Analysis Approach.

Background: Concepts regarding cleft lip and palate care vary widely globally, as there is no international consensus. Consequently, institutional surveillance of cleft concepts is essential. In addition to subjective expert rankings, three-dimensional (3D) photogrammetry of the face has become the gold standard for evaluation and objective assessment of facial structures. We evaluated cleft configuration preoperatively to determine the influence thereof on the long-term facial appearance/averageness of unilateral cleft lip patients. Methods: Plaster models of the patient's labio-oral region and nose were made preoperatively, digitized, and cleft configuration assessed (cleft width, cleft-columella angle, nasal projection, heminasal width ratio, transverse lip length, labial height). Between 4 and 12 years after surgery, stereophotogrammetry (3D face scans) were captured to determine the patients' individual facial averageness index (FAI) as a deviation from the population mean, using proportion indices (PIs) of facial landmarks and reference data provided by Farkas and FaceBase. Results: Cleft width (r = 0.77) and columella length correlated strongly with long-term facial averageness (r = 0.52). Decreasing FAI was seen with increasing patient age (r = -0.42), indicating increasing facial averageness. Other cleft properties showed weaker correlations. Cleft alveolus did not have any impact on FAI. Conclusions: The presented method allows objective measurement of facial appearance/averageness as well as preoperative cleft properties. It might be superior to subjective assessments of facial attractiveness/appearance. Objective cleft measurements are strong predictors for future facial averageness. Increasing averageness with growth and age suggests late corrective surgery.

Patient-specific implant modification for alloplastic bridging of mandibular segmental defects in head and neck surgery.

Displacement of the remaining mandibular segments may occur after alloplastic bridging of mandibular segmental defects using patient-specific reconstruction plates. Consequently, additional surgical devices are required for correct plate positioning. Patient-specific reconstruction plates with a conventional one beam-like design (cPSRP) have been modified by adding two flanges and giving a Y-shape to the distal ascending implant part to allow for segment positioning without using additional devices. We aimed to evaluate reconstruction results after using these modified patient-specific reconstruction plates (mPSRP). We compared the reconstruction results for mPSRP and cPSRP and evaluated mandibular segment dislocations after reconstruction using digital image analysis of the pre- and postoperative radiological data sets. Analysis showed better reconstruction results with mPSRP than with cPSRP; mean dislocation values concerning shifts and rotations of mandibular segments were lower for mPSRP (x-axis: 2.9 mm vs 1.1 mm, 4.2° vs 3.6°; y-axis: 6.0 mm vs 2.0 mm, 3.5° vs 2.8°; z-axis: 3.9 mm vs 3.3 mm, 4.2° vs 1.2°). Significant differences were found for shifts along the y-axis (p = 0.039) and rotations around the z-axis (p = 0.041). Therefore, implant design modifications with additional positioning elements could help simplify surgical reconstruction procedures and improve reconstruction in head and neck surgery.

Nasolabial Flap Improves Healing in Medication-Related Osteonecrosis of the Jaw.

PURPOSE: Medication-related osteonecrosis of the jaw (MRONJ) is an adverse side effect of antiresorptive and antiangiogenic therapeutic agents that is difficult to treat owing to its high relapse rate. The aim of the present study was to determine whether patients with MRONJ treated using decortication and a nasolabial flap compared with those who underwent decortication with mucoperiosteal flaps have better outcomes regarding stable wound closure. MATERIALS AND METHODS: Two groups of patients with MRONJ and intraoral exposed bone were evaluated in a cohort clinical study retrospectively. The primary predictor variable was the treatment group. The experimental group used the nasolabial flap for wound closure, and the control group used the mucoperiosteal flap for closure. The outcome variable was successful wound closure defined as a symptomless and closed wound after at least 12 months. Other study variables included factors such as perioperative drug holiday, duration of postoperative oral antibiotic administration, and postoperative use of nasogastric feeding tubes. Cox proportional hazard regression analysis and Kaplan-Meier curves were used to determine the factors independently associated with the dependent variable. The Mann-Whitney U test and χ2 test were used for analyses regarding group-related data. RESULTS: Both groups showed similar demographics. The 16 study patients receiving nasolabial flaps had a mean age of 69.9 years, and the 16 control patients receiving mucoperiosteal flaps had a mean age of 71.8 years. Both groups included 10 women and 6 men. Of the 16 patients in each group, 15 had received a bisphosphonate and 1, monoclonal antibody therapy. All evaluated patients underwent combined treatment, including decortication and intravenous antibiotics. Of the 16 patients receiving nasolabial flaps, symptomless intact wound closure was achieved in 68.8%. Of the 16 patients with mucoperiosteal closure, 18.7% achieved wound closure, with 81.2% developing a relapse of MRONJ, a statistically significant difference (P < .001). No statistically significant differences were found between the 2 groups in the demographic variables. The mean interval to relapse for the experimental and control groups was 13.6 ± 7.8 and 8.2 ± 7.9 months, respectively (P = .017). CONCLUSIONS: MRONJ is a complication of antiosteoclastic treatment of mostly oncologic, palliative patients, which requires a very methodical approach to surgical treatment. A variety of different methods have been reported. The use of nasolabial flaps can be considered as a highly reliable option for coverage the bone wound with less morbidity than microvascular free flaps and better long-term results compared with mucoperiosteal flaps.

Application of a customized 3D printed reduction aid after external fixation of the femur and tibia: Technical note.

BACKGROUND: To construct a fracture-specific reduction aid by means of virtual reduction technology and 3D printing to reduce malreduced, externally fixed, long bone fractures. TECHNIQUE: Following application of an external fixator to a malreduced long bone fracture, we performed postoperative computed tomography to visualise the fragments and their position relative to Schanz screws. DICOM data were transferred to 3D planning software, and the fracture was then virtually reduced. Subsequently, a reduction aid was designed to cover the Schanz screws in such a way that it would maintain the position of the new fragments. Following 3D printing, the solid reduction aid could be applied onto the Schanz screws. The reduction aid fit only in the reduced position of the fracture, thus maintaining correct bone alignment. CONCLUSION: Our reduction technique can be applied during the temporary external fixation period on the preexisting external fixator or as a reduction aid during definitive treatment.

3D-Printed Simulation Device for Orbital Surgery.

OBJECTIVES: Orbital surgery is a challenging procedure because of its complex anatomy. Training could especially benefit from dedicated study models. The currently available devices lack sufficient anatomical representation and realistic soft tissue properties. Hence, we developed a 3D-printed simulation device for orbital surgery with tactual (haptic) correct simulation of all relevant anatomical structures. DESIGN, SETTING, AND PARTICIPANTS: Based on computed tomography scans collected from patients treated in a third referral center, the hard and soft tissue were segmented and virtually processed to generate a 3D-model of the orbit. Hard tissue was then physically realized by 3D-printing. The soft tissue was manufactured by a composite silicone model of the nucleus and the surrounding tissue over a negative mold model also generated by 3D-printing. The final model was evaluated by a group of 5 trainees in oral and maxillofacial surgery (1) and a group of 5 consultants (2). All participants were asked to reconstruct an isolated orbital floor defect with a titanium implant. A stereotactic navigation system was available to all participants. Their experience was evaluated for haptic realism, correct representation of surgical approach, general handling of model, insertion of implant into the orbit, placement and fixation of implant, and usability of navigated control. The items were evaluated via nonparametric statistics (1 [poor]-5 [good]). RESULTS: Group 1 gave an average mark of 4.0 (±0.9) versus 4.6 (±0.6) by group 2. The haptics were rated as 3.6 (±1.1) [1] and 4.2 (±0.8) [2]. The surgical approach was graded 3.7 (±1.2) [1] and 4.0 (±1.0) [2]. Handling of the models was rated 3.5 (±1.1) [1] and 4 (±0.7) [2]. The insertion of the implants was marked as 3.7 (±0.8) [1] and 4.2 (±0.8) [2]. Fixation of the implants was also perceived to be realistic with 3.6 (±0.9) [1] and 4.2 (±0.45) [2]. Lastly, surgical navigation was rated 3.8 (±0.8) [1] and 4.6 (±0.56) [2]. CONCLUSION: In this project, all relevant hard and soft tissue characteristics of orbital anatomy could be realized. Moreover, it was possible to demonstrate that the entire workflow of an orbital procedure may be simulated. Hence, using this model training expenses may be reduced and patient security could be enhanced.