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.

Manejo del paciente anticoagulado en una cirugía dental / Management of the anticoagulated patient in dental surgery / Gerenciamento do paciente anticoagulado em cirurgia odontológica

Introducción: una adecuada hemostasia es crucial para el éxito del tratamiento odontológico invasivo, ya que los problemas de sangrado pueden dar lugar a complicaciones asociadas a una importante morbimortalidad. El tratamiento odontológico de pacientes que tienden a un mayor riesgo de sangrado debido al uso de fármacos anticoagulantes plantea un desafío en la práctica diaria de los profesionales de la odontología. El conocimiento adecuado de los mecanismos subyacentes a la hemostasia y el manejo optimizado de estos pacientes son, por lo tanto, cuestiones muy importantes. Se realiza un estudio de los fármacos anticoagulantes actualmente disponibles en el mercado, evaluando los riesgos y beneficios de suspender dicho fármaco previo a un tratamiento odontológico invasivo. Además, se hace una revisión de los protocolos de manejo actuales que se utilizan en estos pacientes. Material y métodos: se realizó una búsqueda bibliográfica en las bases de datos Epistemonikos y Medline/PubMed; en el portal Timbó y en la biblioteca virtual Scielo. Abarcando todos los estudios publicados en los últimos 15 años en inglés y español. Se encontraron 30 artículos, se seleccionaron 15 en primera instancia para finalizar con 11 artículos. En dicha selección el filtro fue que los demás artículos se referían a otros anticoagulantes que no eran parte de este trabajo. Resultados: se han desarrollado múltiples protocolos de manejo, aunque en todos los casos se requiere una historia clínica completa, junto con pruebas hemostáticas complementarias para minimizar los riesgos derivados del tratamiento odontológico. Discusión: muchos autores consideran que la medicación de los pacientes indicada para el tratamiento de una enfermedad de base no debe ser alterada o suspendida a menos que así lo indique el médico prescriptor. Se ha demostrado que las medidas hemostáticas locales son suficientes para controlar los posibles problemas de sangrado derivados del tratamiento dental.

Introduction: Adequate hemostasis is crucial for the success of invasive dental treatment, since bleeding problems can lead to complications associated with significant morbidity and mortality. The dental treatment of patients who are prone to an increased risk of bleeding due to the use of anticoagulant drugs poses a challenge in the daily practice of dental professionals. Adequate knowledge of the mechanisms underlying hemostasis and optimized management of these patients are therefore very important issues. A review is made of the anticoagulant drugs currently available on the market, evaluating the risks and benefits of suspending such a drug prior to invasive dental treatment. In addition, a review is made of the current management protocols used in these patients. Material and methods: A bibliographic search was carried out in the Epistemonikos and Medline/PubMed databases; in the Timbo portal and in the Scielo virtual library. All the studies published in the last 15 years in English and Spanish were included. Thirty articles were found, 15 were selected in the first instance to end up with 11 articles. In this selection, the filter was that the other articles referred to other anticoagulants that were not part of this work. Results: multiple management protocols have been developed, although in all cases a complete clinical history is required, together with complementary hemostatic tests to minimize the risks derived from dental treatment. Discussion: many authors consider that the patient's medication indicated for the treatment of an underlying disease should not be altered or suspended unless so indicated by the prescribing physician. It has been shown that local hemostatic measures are sufficient to control possible bleeding problems derived from dental treatment.

Introdução: A hemostasia adequada é crucial para o sucesso do tratamento dentário invasivo, pois problemas de sangramento podem levar a complicações associadas a uma morbidade e mortalidade significativas. O tratamento odontológico de pacientes que são propensos a um risco maior de sangramento devido ao uso de drogas anticoagulantes representa um desafio na prática diária dos profissionais da odontologia. O conhecimento adequado dos mecanismos subjacentes à hemostasia e o gerenciamento otimizado desses pacientes são, portanto, questões muito importantes. É realizada uma revisão dos anticoagulantes atualmente disponíveis no mercado, avaliando os riscos e benefícios de descontinuar tal medicamento antes do tratamento dentário invasivo. Além disso, é feita uma revisão dos protocolos de gerenciamento atuais usados nesses pacientes. Material e métodos: Foi realizada uma pesquisa bibliográfica nas bases de dados Epistemonikos e Medline/PubMed; no portal Timbo e na biblioteca virtual Scielo. Todos os estudos publicados nos últimos 15 anos, em inglês e espanhol, foram incluídos. Trinta artigos foram encontrados, 15 foram selecionados em primeira instância para acabar com 11 artigos. Nesta seleção, o filtro foi que os outros artigos se referiam a outros anticoagulantes que não faziam parte deste trabalho. Resultados: foram desenvolvidos múltiplos protocolos de gerenciamento, embora em todos os casos seja necessário um histórico clínico completo, juntamente com testes hemostáticos complementares para minimizar os riscos derivados do tratamento odontológico. Discussão: muitos autores consideram que a medicação os pacientes indicada para o tratamento de uma doença subjacente não deve ser alterada ou descontinuada, a menos que o médico que a prescreve dê instruções nesse sentido. Medidas hemostáticas locais demonstraram ser suficientes para controlar potenciais problemas de sangramento resultantes do tratamento odontológico.

Has the time come for de-escalation in the management of oropharyngeal carcinoma?

Over the course of the last two decades, there has been a decrease in the incidence of head and neck cancers thanks to a decreasing prevalence of smoking. However, a new risk factor has been coming to the fore: human papillomavirus infection (HPV). HPV-positive oropharyngeal squamous cell carcinoma (HPV+OPC) is more sensitive to chemotherapy and radiotherapy, which translates to a much better prognosis with conventional treatment protocols than tumours that are HPV-negative. Traditional therapeutic interventions are associated with substantial morbidity and have a great impact on patient quality of life. The main focus is on identifying an ideal group of HPV-positive patients who could receive de-intensification treatment regimens aimed at avoiding the late toxicity of treatment. Various strategies are considered, such as reduction in radiotherapy dose following induction chemotherapy, radiotherapy alone, minimally invasive surgical techniques, and substituting platinum-based chemotherapy. The first generation of de-escalation randomised phase III trials have now been published. The following review summarizes the current knowledge and treatment of oropharyngeal carcinoma.

[Management of adverse events in an Oral and Maxillofacial Surgery Unit]. / Gestión de eventos adversos en un Servicio de Cirugía oral y Maxilofacial.

INTRODUCTION: Patient safety in oral and maxillofacial surgery is oriented towards providing patient care by means of adequate risk management that minimises adverse events and fosters a culture of safe clinical practices as the fundamental basis of quality health care. To implement preventive actions are implemented in order to improve patient safety and to reduce the incidence of adverse events, as well as to improve the quality of care. The aim of this report is to implement preventive measures in order to improve the health care of the patient in an Oral and Maxillofacial Surgery Unit by reducing the Adverse Events and proving good quality healthcare. MATERIALS AND METHODS: A longitudinal, prospective, single centre study was conducted using a methodology of analysis of modes of failure and effects of the management of potentially serious adverse events in the Oral and Maxillofacial surgical unit of the University Hospital of Granada (June-November 2017), as well as the preparation and implementation of a series of corrective measures. RESULTS: A total of 33 adverse events were recorded, with 10 of them considered as critical, distributed in different areas of care, and referred from Primary Health Care and from other hospitals. Seven preventive actions were implemented: information to the patient, training actions, improvements in the protocols and procedures, in the care process and clinical practice, as well as the need to set up an adequate checklist, and other miscellaneous. DISCUSSION: The implementation of preventive measures represent a notable advance in the prevention of harm to the patient and the organisation, involving healthcare staff in a safety culture oriented towards quality care.

Protocolo de atendimento odontológico a pacientes usuários de terapia antitrombótica / Dental care protocol for patients using antithrombotic therapy

Muitos pacientes que necessitam de intervenção odontológica, atualmente, são usuários de terapia medicamentosa antitrombótica. Essa condição se mostra prevalente, considerando que problemas cardiovasculares afetam grande parte da população. Objetivo: construir um protocolo clínico para o Serviço de Odontologia e Estomatologia do Hospital das Clínicas de Ribeirão Preto da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo, a partir de evidências científicas. Revisão de literatura: foi realizada uma pesquisa bibliográfica nas bases de dados eletrônicas Scientific Eletronic Library Online (SciELO) e Public MedLine (PubMed), nos idiomas português e inglês, do período entre 2013 e 2017. Após obtenção dos periódicos, foram selecionados os que se tratavam de estudos clínicos e seguiu-se com tradução, leitura e análise dos artigos. Com base nas evidências científicas, optou-se por construir o protocolo a partir da classe de medicamento utilizada pelos usuários de terapia antitrombótica (antiagregantes plaquetários, anticoagulantes orais e novos anticoagulantes orais) e orientações (pré, intra e pós-operatórias) para cada procedimento odontológico. Considerações finais: o protocolo clínico estabeleceu parâmetros para condutas clínicas e cirúrgicas em atendimento ambulatorial e hospitalar, possibilitando o cuidado integral aos usuários de terapia antitrombótica. Futuros estudos clínicos são necessários para validação e adequação para seu uso em diferentes serviços. (AU)

Several patients who require dental intervention are current users of antithrombotic drug therapy. This condition is prevalent, considering that cardiovascular problems affect a large portion of the population. Objective: this study aimed to construct a clinical protocol for the Service of Dentistry and Stomatology of the Clinics Hospital of Ribeirão Preto from the Medical School of Ribeirão Preto of the University of São Paulo, Brazil, based on scientific evidence. Literature review: a bibliographic review was performed in the Scientific Electronic Library Online (SciELO) and Public MedLine (PubMed) electronic databases, in the Portuguese and English languages, for the period of 2013 through 2017. After obtaining the journals, the clinical studies were selected, followed by the translation, reading, and analysis of the articles. Based on the scientific evidence, we decided to build the protocol from the class of medication of the users of antithrombotic therapy (antiplatelet agents, oral anticoagulants, and new oral anticoagulants), and guidelines (pre-, intra-, and postoperative) for each dental procedure. Final considerations: the clinical protocol established parameters for clinical and surgical procedures in outpatient and hospital care, allowing comprehensive care to users of antithrombotic therapy. Further clinical studies are required to validate and adequate the use of this therapy in different services. (AU)

Evaluation of Staff Satisfaction After Implementation of a Surgical Safety Checklist in the Ambulatory of an Oral and Maxillofacial Surgery Department and its Impact on Patient Safety.

PURPOSE: Safety checklists in medicine have been shown to be effective in the prevention of complications and adverse events in patients undergoing surgery. Such checklists are not as common in dentistry. The aims of this study were to propose a safety checklist for the ambulatory treatment of patients undergoing oral and implant surgery and to assess its impact on patient safety and staff satisfaction. MATERIALS AND METHODS: After implementation of a surgical safety checklist in the ambulatory treatment of patients undergoing oral and implant surgeries, a questionnaire regarding staff satisfaction and safety-related parameters was randomly administered. Incidents, complications, and adverse events were documented. Outcomes with (n = 40 surgeries) and without (n = 40 surgeries) use of the checklist were analyzed and compared. RESULTS: Staff reported high satisfaction with the use of the checklist, which demonstrably improved team communication and lowered stress levels during surgery. There was a statistically significantly higher frequency of reported incidents without the use of the checklist (n = 43) than with the use of the checklist (n = 10; P = .000). Most incidents were reported in the context of pre- and post-procedural processes. CONCLUSIONS: Safety checklists help to improve work processes, optimize communication, and lower stress levels. Their use in clinical dental practice is recommended.

Surgical Safety Checklists Are Underutilized in Ambulatory Oral and Maxillofacial Surgery.

PURPOSE: The objective of this study was to determine attitudes toward and the prevalence of using a surgical safety checklist in ambulatory oral and maxillofacial surgery (OMS) practice. MATERIALS AND METHODS: The authors designed and implemented a cross-sectional study and enrolled a random sample of oral and maxillofacial surgeons. The predictor variable was years removed from residency. The primary outcome was the prevalence of surgical safety checklist usage in ambulatory OMS practice. The secondary outcome was to determine whether surgeons who do not currently use a checklist would be willing to do so if provided with one. Other demographic variables included age, gender, location of practice, type of practice, and number of ambulatory procedures performed per week. Appropriate uni- and bivariate statistics were computed and the level of significance set at .05; 95% confidence intervals also were calculated. RESULTS: The study sample was composed of 120 clinicians. Forty-two percent of respondents reported that they were not using a surgical safety checklist for ambulatory surgery. Ninety-three percent of those respondents not currently using a checklist reported they would consider implementing a surgical safety checklist in their practice if provided with one. In addition, 45.3% of surgeons performing more than 30 procedures a week reported not using a surgical safety checklist. Most respondents (67.9%) who had completed OMS training more than 20 years previously reported not using a checklist in their practice. CONCLUSION: According to this survey, most practicing oral and maxillofacial surgeons do not currently use surgical safety checklists. Although the response rate was only 12%, the survey does reflect a clear lack of use of checklists among practicing oral and maxillofacial surgeons despite its widespread acceptance in the medical community.

How did we do? An investigation into the suitability of patient questionnaires (PREMs and PROMs) in three primary care oral surgery practices.

Introduction With the expansion of oral surgery services into the primary care sector there is a need to monitor the quality of the care provided. The Guide for Commissioning Oral Surgery and Oral Medicine proposed a set of questions to be used as patient related experience and outcome measures (PREMs and PROMs).Aim The British Association of Oral Surgeons (BAOS) primary care group (which includes the authors) were tasked by the Chief Dental Officer for England to test the suitability of these PREMs and PROMs.Method The questions as published in the commissioning guide were piloted in primary care oral surgery practices and patient feedback was sought. The authors then proposed and implemented an amended series of questions that they felt would be more practical as generic templates for oral surgery services.Results Our data demonstrates that the revised questions have produced data that is easy to interpret and attracted a greater number of feedback comments from patients.Discussion and conclusion The revised questionnaires incorporate the NHS Friends and Family Test as the collection of this data is normally a contractual requirement for providers of NHS services. They also use questions from other validated healthcare satisfaction survey tools. The use of Likert scales provides a richer data set which makes the interpretation of data easier and highlights areas for improvement. It is important to note that the data provided by PREMs and PROMs is subject to a number of biases and should be used for local quality improvement and longitudinal analysis of outcome data rather than comparison between providers.

Senior Oral and Maxillofacial Surgery Resident Confidence in Performing Invasive Temporomandibular Joint Procedures.

PURPOSE: The purpose of this study was to evaluate the level of confidence that senior-level oral and maxillofacial surgery (OMS) residents have in the management of temporomandibular joint (TMJ) disorders, determine their exposure to various invasive TMJ procedures during training, and assess their confidence in performing those procedures on completion of residency. MATERIALS AND METHODS: A questionnaire was designed, and a link to a University of Illinois at Chicago Qualtrics Survey platform (Qualtrics, Provo, UT) was e-mailed to all program directors at Commission on Dental Accreditation-accredited OMS training programs in the United States. The program directors were asked to forward the 20-multiple-choice question anonymous survey to their senior-level residents for completion. The survey included the program's demographic characteristics, resident's confidence in assessing and managing patients with temporomandibular disorders (TMDs), resident's experience performing various invasive TMJ procedures, and whether the resident believed he or she had received sufficient education and clinical experience in the management of TMJ disorders. The data were collected and summarized by use of a standard spreadsheet analysis, as well as appropriate descriptive and analytical statistical tests. RESULTS: The response rate was 28.0%. Of the 56 respondents, 52 (92.9%) reported having received instruction in nonsurgical management of TMDs. All respondents confirmed that invasive TMJ procedures were performed in their program. The most commonly performed procedure was TMJ arthrocentesis (mean rating, 3.11), followed by open TMJ surgery (mean rating, 2.82). The least-performed invasive surgical procedure was autogenous total TMJ replacement surgery (mean rating, 1.39). Eighty percent of residents reported being comfortable managing the TMD patient. The only procedure with which the respondents were highly confident was TMJ arthrocentesis (mean rating, 3.89). CONCLUSIONS: This study suggests that confidence levels in the management of the TMD patient are related directly to the invasive TMJ procedure experience obtained during residency. This finding may have implications on the practice patterns of OMS surgeons as it relates to access to care for the TMD patient.

Cleft and Craniofacial Clinic Formats in the United States: National and Institutional Survey.

BACKGROUND: Craniofacial teams employ multidisciplinary clinics to optimize patient care. Different clinic formats exist among teams. Formats include providers rotating from room to room as separate specialties, patients rotating from room to room to either separate specialties or as 1 group, as well as providers rotating together as 1 group. Surveys were used to study family preferences between the different formats and to compare them with trends of national practices. METHODS: Families of the authors' team clinic patients were surveyed from November 2012 to February 2013, after a clinic format change from patients moving between rooms to see providers, to providers moving between rooms to see patients. This survey focused on patient satisfaction, clinic format preference, and their perception of efficiency. A second, national survey was distributed to 161 American craniofacial teams approved by the American Cleft Palate-Craniofacial Association to survey clinic formats, provider satisfaction, and experience with other formats. Institutional survey data were tabulated as percentages and further analyzed using the Mann-Whitney Test. The national survey data was then tabulated and compared with authors' institutional results. RESULTS: Thirty-nine of 54 (72.2%) families responded to the institutional survey. Providers moving between rooms were associated with greater patient satisfaction (mean 4.8 of 5, 5 being most satisfied) (0<0.0001), shorter perceived clinic time (76.9%), and an increased sense of comfort (84.6%). The difference in satisfaction rates was statistically significant (P <0.0001) between the primary clinic formats of providers rotating (mean of 4.8) and patients rotating (mean of 2.4).The national survey had 93 responses of 161 (57.7%). 54.9% of respondents have providers rotating between examination rooms, and 32.3% have patients moving between rooms. Other formats included the entire team moving as a group between rooms (10.8%) and specialties sitting together in 1 room while patients rotate (9.7%). Respondents were satisfied with current formats (mean 4.24 of 5, 5 being most satisfied). 22.2% had tried a different format previously. CONCLUSION: The most common American cleft and craniofacial clinic format is providers moving between rooms; however, all formats have high provider satisfaction. At our institution, patients prefer when providers move between rooms. Our study suggests that clinic formats do not need to be standardized, and the clinic format utilized should be tailored to the individual needs of the institution.

Sleep surgery tool: A medical checklist to review prior to operating.

OBJECTIVE: The objective of this study was to systematically review the international literature for studies providing a preoperative checklist for medical disorders to be evaluated or treated before performing sleep surgery. If no checklist exists, then studies providing recommendations would be used to develop a checklist de novo. STUDY DESIGN: Systematic review combined with expert opinion. METHODS: Four databases, including PubMed/Medline were searched through August 10, 2016. RESULTS: 453 potentially relevant studies were screened, 32 were downloaded for full review. No study included a preoperative checklist. No study provided guidance for specific medical disorders to evaluate or screen for prior to sleep surgery. Therefore, we reviewed articles in adults that provided recommendations such as: (1) labs to review, (2) non-operative disorders to evaluate and treat, and (3) comorbidities to optimize prior to performing sleep surgery. These articles were utilized in conjunction with expert opinion to develop a preoperative checklist for surgical guidance. CONCLUSION: There are several items to review prior to performing sleep surgery on obstructive sleep apnea patients. This systematic review and expert opinion-based checklist provides over twenty items for reviewing prior to performing sleep surgery to reduce the chance of operating prematurely.

[Recent increase in simple extractions in OMF-surgeries in the Netherlands studied]. / Recente toename van reguliere extracties in mka-chirurgie onderzocht.

Tooth extraction is a treatment that can be carried out by general dental practitioners. It is suspected that the number of referrals to OMF-surgeons for simple tooth extractions has increased in the Netherlands in recent years. In a study, the health records of 2 groups of outpatients treated at the Oral and Maxillofacial Surgery department of a university medical centre between 1996 and 2014 were investigated. Patients who had undergone tooth extractions were included. The complexity of the tooth extractions was analyzed according to 4 criteria. The results of the study show a significant increase in simple tooth extractions by OMF surgeons in 2014 in comparison with 1996. The complexity of the total number of tooth extractions in 2014 was lower than in 1996. Reasons for these results could not be unambiguously determined. Possible significant aspects are the risk of per-operative complications, insufficient affinity of general dental practitioners with tooth extractions or financial considerations on the part of both the general dental practitioners and the patients.

Transoral Surgery or Radiotherapy for Oropharyngeal Carcinoma - Is It Either Or ?

The management of oropharyngeal carcinoma represents an increasing clinical challenge, because of its rising incidence, particularly in younger patients as a result of human papillomavirus (HPV) infection, and because significant technological advances have occurred in radiotherapy and surgery over the last 10 years that have increased treatment options for patients, with little robust evidence yet of their relative merits. As a result, there is a lack of clinical consensus on the optimum treatment modality, reflected in wide variation in practice between different cancer networks across the UK. Here, we consider the evidence base for minimally invasive transoral surgery and for intensity-modulated radiotherapy-based primary treatment for oropharyngeal cancer, in terms of both oncological and functional outcomes. Management strategies for HPV-positive and HPV-negative disease, and for different stages of the disease, are considered. There is currently an unparalleled opportunity to shape the future management of oropharyngeal cancer, which is dependent on recruiting patients to ongoing clinical trials, in order to build an evidence base to support a clinical consensus on the optimal treatment strategies. It appears likely that future evidence-based decision-making will use both primary radiotherapy and primary surgical treatment modalities to maximise patient benefit.