Approaching 3D printing in oral and maxillofacial surgery - suggestions for structured clinical standards.

PURPOSE: With respect to the European Union 2017 amendment of the Medical Device Regulations (MDR), this overview article presents recommendations concerning medical 3D printing in oral and maxillofacial surgery (OMFS). METHODS: The MDR were screened for applicability of the rules to medical in-house 3D printing. Applicable regulations were summarized and compared to the status of medical use of 3D printing in OMFS in Germany. Recommendations were made for MDR concerning medical 3D printing. RESULTS: In-house printed models, surgical guides, and implants fall under the category of Class I-III, depending on their invasive and active properties. In-house medical 3D printing for custom-made medical devices is possible under certain prerogatives: (1) the product is not being used in another facility, (2) appropriate quality systems are applied, (3) the reason for omitting commercial products is documented, (4) information about its use is supplied to the responsible authority, (5) there is a publicly accessible declaration of origin, identification, and conformity to the MDR, (6) there are records of manufacturing site, process and performance data, (7) all products are produced according to the requirements proclaimed before, and (8) there is an evaluation of clinical use and correction of possible issues. CONCLUSION: Several aspects must be addressed for in house medical 3D printing, according to the MDR. Devising MDR related to medical 3D printing is a growing challenge. The implementation of recommendations in OMFS could help practitioners to overcome the challenges and become aware of the in-house production and application of 3D printed devices.

Microvascular reconstructions in oral and maxillofacial surgery - Results of a survey among oral and maxillofacial surgeons in Germany, Austria, and Switzerland.

This study aimed to evaluate the use of microvascular free flaps (MFF) in oral and maxillofacial surgery (OMFS) in Germany, Austria, and Switzerland. A dynamic online questionnaire, using 42-46 questions, was sent to OMF surgeons based in hospitals in Germany, Austria, and Switzerland. The questionnaire was evaluated internally and externally. Aside from general information, data were collected on organizational aspects, approaches, MFF types and frequency, presurgical planning, intraoperative procedures, perioperative medications, flap monitoring, and patient management. Participants mostly performed 30-40 MFF each year (11/53). Most stated that the COVID-19 pandemic did influence MFF frequency (25/53) to varying extents. Radial forearm flap was most frequently used (37/53), followed by ALT (5/53), and fibula flap (5/53). Primary reconstruction was performed by most participants (35/48). Irradiated bony transplants were mostly used for implant placement after 12 months (23/48). Most participants (38/48) used reconstruction plates, followed by miniplates (36/48), PSI reconstruction (31/48), and PSI miniplates (10/48). Regarding the postoperative use of anticoagulants, low-molecular-weight (37/48) and unfractioned heparins (15/48) were widely used, most often for 3-7 days (26/48). Clinical evaluation was mostly preferred for flap monitoring (47/48), usually every 2 h (34/48), for at least 48 h (19/48). Strong heterogeneity in MFF reconstructions in OMFS was found, especially regarding the timepoints of reconstruction, types of osteosynthesis, and postoperative MFF management. These findings provide the chance to further compare the different treatment algorithms regarding relevant MFF aspects, such as postoperative management. This could create evidence-based treatment algorithms that will further improve the clinical outcomes in MFF reconstructions.

A survey regarding the organizational aspects and quality systems of in-house 3D printing in oral and maxillofacial surgery in Germany.

PURPOSE: The aim of the study was to get a cross-sectional overview of the current status of specific organizational procedures, quality control systems, and standard operating procedures for the use of three-dimensional (3D) printing to assist in-house workflow using additive manufacturing in oral and maxillofacial surgery (OMFS) in Germany. METHODS: An online questionnaire including dynamic components containing 16-29 questions regarding specific organizational aspects, process workflows, quality controls, documentation, and the respective backgrounds in 3D printing was sent to OMF surgeons in university and non-university hospitals as well as private practices with and without inpatient treatment facilities. Participants were recruited from a former study population regarding 3D printing; all participants owned a 3D printer and were registered with the German Association of Oral and Maxillofacial Surgery. RESULTS: Sixty-seven participants answered the questionnaires. Of those, 20 participants ran a 3D printer in-unit. Quality assurance measures were performed by 13 participants and underlying processes by 8 participants, respectively. Standard operating procedures regarding computer-aided design and manufacturing, post-processing, use, or storage of printed goods were non-existent in most printing units. Data segmentation as well as computer-aided design and manufacturing were conducted by a medical doctor in most cases (n = 19, n = 18, n = 8, respectively). Most participants (n = 8) stated that "medical device regulations did not have any influence yet, but an adaptation of the processes is planned for the future." CONCLUSION: The findings demonstrated significant differences in 3D printing management in OMFS, especially concerning process workflows, quality control, and documentation. Considering the ever-increasing regulations for medical devices, there might be a necessity for standardized 3D printing recommendations and regulations in OMFS.

An update on the current training situation of German interns in oral and maxillofacial surgery at special times in 2021.

The aim of this study was to evaluate the current state of training of German interns in oral and maxillofacial surgery (OMFS) under the influence of the COVID-19 pandemic in 2021. A previously tested questionnaire consisting of 53 questions was sent to interns in German OMFS (non-) university hospitals and private practices as an online survey. The questionnaire was adapted to current topics, such as the ongoing COVID-19 pandemic, aspects concerning nighttime and weekend services, overtime hours, surgical logbooks, benefits of academic degrees and support for scientific activities, part-time employment, parental leave and childcare. Next, results of questions from before the COVID-19 pandemic were re-evaluated. The COVID-19 pandemic influenced the clinical work (71.83%) and the current state of training (68.64%) in OMFS of most participants. Nighttime and weekend services are possible for employees in possession of only one degree (87.93% with a medical degree) in most hospitals. Not having one or both doctorate degrees was considered to be a disadvantage by 54.95%. In all, 42.11% of the participants attested to a positive influence of research on their training situation, and 50% reported financial or non-financial research support from the employer. Part-time employment was possible for 78.81% of the participants. The course of training was interrupted more often for women due to parental or maternity leave (10.53% of men and 30.95% of women). A total of 40.71% of the participants reported that childcare was available at the hospital, theoretically. The state of OMFS training in Germany can be referred to as positive. Current and future challenges are diverse, including aspects originating from the ongoing COVID-19 pandemic, gender aspects, reconciliation of family and work, and flexible working hours. Addressing these topics will ensure OMFS training at the highest surgical level and further increase interns' satisfaction, preserving the specialty's popularity and reception.

3D printing in oral and maxillofacial surgery: a nationwide survey among university and non-university hospitals and private practices in Germany.

OBJECTIVES: Oral and maxillofacial surgery (OMFS) has undergone pioneering progress through the development of three-dimensional (3D) printing technologies. The aim of this study was to evaluate the use of 3D printing at OMFS university and non-university hospitals and private practices in Germany. MATERIALS AND METHODS: For explorative assessment, a dynamic online questionnaire containing 10-22 questions about the current use of 3D printing and the reasons behind it was sent to OMFS university and non-university hospitals and private practices in Germany by the study group from the German Association of Oral and Maxillofacial Surgery (DGMKG). RESULTS: In total, 156 participants responded from university (23 [14.7%]) and non-university hospitals (19 [12.2%]) and private practices without (85 [50.5%]) and with 29 (18.6%) inpatient treatment facility. Highest applications of 3D printing were in implantology (57%), microvascular bone reconstructions (25.6%), and orthognathics (21.1%). Among the participants, 37.8% reportedly were not using 3D printing. Among the hospitals and private practices, 21.1% had their own 3D printer, and 2.5% shared it with other departments. The major reason for not having a 3D printer was poor cost efficiency (37.6%). Possessing a 3D printer was motivated by independence from external providers (91.3%) and rapid template production (82.6%). The preferred printing methods were stereolithography (69.4 %) and filament printing (44.4%). CONCLUSIONS: OMFS 3D printing is established in Germany with a wide range of applications. CLINICAL RELEVANCE: The prevalence of 3D printing in hospitals and private practices is moderate. This may be enhanced by future innovations including improved cost efficiency.

How is neck dissection performed in Oral and Maxillofacial Surgery? Results of a representative nationwide survey among university and non-university hospitals in Germany.

INTRODUCTION: Neck dissection (ND) is a surgical procedure addressing cervical lymph nodes and metastases in patients with oral squamous cell carcinoma (OSCC). The aim of this study was to analyze clinical decisions regarding indications and variations of ND in Oral and Maxillofacial Surgery (OMFS) in Germany. MATERIAL AND METHODS: A nationwide survey of the German Association of Oral and Maxillofacial Surgery was performed using dynamic online questionnaires including 38 questions. Data about oncological centers, case numbers, and staging procedures were collected. Relevant aspects, such as inclusion of level IIb and levels IV and V to ND, uni- vs. bilateral ND, and the influence of extra-nodal extension (ENE) of metastases on extension of ND were evaluated. RESULTS: Eighty-four OMFS of university and non-university hospitals participated in the study (responding rate 21.4%). Sixty-six (78.57%) stated to work at certified cancer centers and 53.57% of the hospitals treated between 50 and 100 OSCC cases per year. CT and/or MRI of the head and neck was performed in most of the staging procedures. Level IIb was included by 71 (93.42%) of the participants in selective ND. Levels IV and V were included by 53 (69.74%) in node-positive neck. In solitary ipsilateral metastases (ENE-), 49 participants (62.82%) stated to perform exclusively an ipsilateral ND and 40 (51.95%) stated to perform only an ipsilateral ND in ENE+. CONCLUSION: This study demonstrated a high rate of certified cancer centers in Germany showing differences regarding staging procedures, indications, and extension of ND, especially in increasingly complex cases. CLINICAL RELEVANCE: Clinical decisions regarding ND are dependent on case-individual aspects and must be decided individually.

Training in oral and maxillofacial surgery in Germany - Residents' satisfaction and future challenges.

The aim of this study was to analyze the current situation of trainees in OMFS in a nationwide survey at German universities and teaching hospitals. A questionnaire about their training in OMFS and discrimination, gender (in-)equality, and reconcilability of work and family life was sent to many OMFS residents in Germany. Seventy-five questionnaires were included. The average age of the participants was 32.15 years (± 0.75 years); 47 participants were male, 22 female, and 3 "diverse". The participants' overall satisfaction rate was good. Training concepts existed in most of the teaching hospitals (54.67%). 8.11% of the participants stated discrimination existed against men while, 24.32% agreed that discrimination existed against women. Stating that discrimination against women exists, it was associated with female gender (p < 0.001), being married (p = 0.042), and not aiming for further academic degrees (p = 0.009). Overall, the training situation in Germany seems structured in most teaching hospitals. Apart from the residents' general satisfaction with the training concepts, there seems to be a matter of concern regarding discrimination especially against women and the reconcilability of work and family life in OMFS training. Furthering the establishment of structured training concepts might be useful to overcome these issues in the course of training in OMFS.

The influence of the SARS-CoV-2 pandemic on oral and maxillofacial surgery: a nationwide survey among 54 hospitals and 240 private practices in Germany.

OBJECTIVE: The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic has created hitherto unknown challenges for healthcare systems and patient care. This study aimed to analyze its influence on patient care and healthcare management in oral and maxillofacial surgery (OMFS) in Germany. MATERIALS AND METHODS: A nationwide survey of the German Association of Oral and Maxillofacial Surgery was performed. Individual questionnaires containing 10 questions for university as well as non-university hospitals and 15 questions for private practices (PPs) for OMFS were created to collect data for patient numbers and surgical procedures conducted, usage of personal protection equipment (PPE), SARS-CoV-2 tests, and economic aspects. RESULTS: Fifty-four hospitals and 240 PPs participated in the study. The reduction in ward capacities and number of surgical procedures ranged from 17 to 78%. PPE consisted of standard surgical masks (58% hospitals, 64% PPs) and FFP2/N95/KN95 respirators (45% hospitals, 48% PPs). Preoperative SARS-CoV-2 tests were more frequently performed in hospitals (34% vs 2%). At PPs, turnover for medical and dental procedures billed to the public insurance had reduced to 58.81% and 62.43%, respectively, of the corresponding values for 2019, and 58.75% of the PPs had applied for short-time allowances. CONCLUSION: With the exception of some elective procedures, primary patient care in OMFS has been assured during the pandemic. However, the immense economic burden on hospitals and PPs cannot be conclusively assessed at this point. CLINICAL RELEVANCE: For OMFS, the German healthcare system has shown the ability to adapt to emergency situations such as the SARS-CoV-2 pandemic. Adequate surgical capacities in OMFS are necessary even during pandemics.

Accurate and cost-effective mandibular biomodels: a standardized evaluation of 3D-Printing via fused layer deposition modeling on soluble support structures.

INTRODUCTION: Medical biomodels can be used for illustration of medical conditions, preoperative planning or to facilitate pre-bending of osteosynthesis material. They have been shown to be an effective and efficient method to reduce operating time, blood loss and wound stress in cranio-maxillo-facial surgery. Lately, new time and cost-efficient 3D-printing methods have been introduced into the mass-market. The aim of this study was to establish a standardized method of evaluation and consequently evaluate Fused Layer Deposition Modeling in combination with soluble support structures for fabrication of medical biomodels regarding precision and cost-effectiveness. MATERIALS & METHODS: Twenty-one biomodels of human mandibles equipped with measuring appliances were printed on a FLDM 3D-printers (Ultimaker 3 Extended) using a polyactate filament and a water-soluble Polyvinyl alcohol-based support structures. Precision of these models was compared to commercial, polyamide sintered models and the planning data. Production costs, printing times and post processing procedures were evaluated. RESULTS: Duration of printing of mandibular biomodels was between 6 h 5 min - 15 h 9 min (mean 9 h 12 min, ±2 h 25 min). The average cost of materials was €5.90 (± €1.28) per model. With an average aberrance of 0.29 mm, FLDM printing delivered a high level of accuracy. It was significantly superior to the polyamide reference models in the area of the semilunar incision, yet inferior at the coronoid process. CONCLUSION: FLDM printers are able to provide very precise biomodels at very low costs. The use of using soluble support structures reduces time, costs and equipment needed for post processing procedures close to zero.

Postgraduate training in Oral- and Maxillofacial Surgery: Results of a survey among 74 German interns.

The aim of this study was to asses a survey of residents to obtain relevant information about their current situation in training in Oral and Maxillofacial Surgery in Germany. Special focus was given to the personal and clinical preferences of the residents, their main subjects of interest and plans after residency. Furthermore, the different principles of education at German teaching hospitals were evaluated. Overall, 74 questionnaires were completed on a voluntary and anonymous basis by German residents for Oral and Maxillofacial Surgery. Participants' mean age was 32.74 years (68% male, 27% female). Most participants were in the fifth year of training (32%) and members of the German Association of Oral and Maxillofacial Surgery (70%). This rate increased with progress in residency (p = 0.006). Most residents (70%) were employed at university hospitals, followed by non-university hospitals (26%) and private practices (4%). Residents from university hospitals (3.06 ± 0.39 years) were less advanced in training compared to residents from non-university hospitals and private practices (4.10 ± 0.54 years; p = 0.005). Part-time employed residents were significantly younger (30.64 ± 2.37 years) than full-time employed residents (33.25 ± 0.64 years, p = 0.002). Structured concepts of training existed in 64% of the hospitals, while training depending on the current year of residency (42%) was most common. Most of the residents would prefer a systematic rotation system (59%). Main subjects of clinical interest were aesthetic (50%) and orthognathic surgery (46%). The interest in dento-alveolar surgery (34%) significantly increased with participants' age (p = 0.008). Clefts and malformations were favoured by few residents (16%). Most participants planned to specialize in facial plastic surgery after residency (76%). The data collected might give evidence for an increasing importance of structured training concepts in Oral and Maxillofacial Surgery. It might be relevant to enhance the interest and the excitement of residents for oncology, traumatology, cleft and malformation surgery.