[Legislative and regulatory framework of medical products circulation]. / Zakonodatel'naia i normativnaia pravovaia baza v sfere obrashcheniia meditsinskikh izdelii.

An important task of modern public health is improvement of quality of rendering of medical aid to the population. Means for its support at all stages of the serve of a medical device (instruments, apparatus, materials, etc.), quality, safety and efficacy which play a key role to maintain and improve the quality of life of the population.

Comparative analysis of 2 resonance frequency measurement devices: Osstell Mentor and Osstell ISQ.

OBJECTIVE: Comparing reliability of Osstell Mentor and Osstell ISQ in implant stability measurement, and assessing whether their measurements are comparable. MATERIALS AND METHOD: Implant stability was measured with both devices on 58 implants in 15 patients. Six measurements were completed with each device with 2 different transducers (3 measurements with each transducer), that is, 12 measurements for each implant. RESULTS: Mean implant stability quotient (ISQ) value with Osstell ISQ was 72.59, 72.47, and 73.17 in the first measurements, respectively. With Osstell Mentor, the results were 72.43, 72.60, and 73.26, respectively; mean ranges were 3.37, 3.60, and 3.75, respectively. However, mean value with Osstell ISQ and Osstell Mentor was 72.87 and 72.04, respectively. The intraclass correlation coefficient was 0.98. This means an almost perfect degree of concordance between both devices. CONCLUSIONS: Resonance frequency analysis systems in Osstell Mentor and Osstell ISQ show almost perfect reproducibility and repeatability.

[Expert consensus of regulations for the application of zero suckback technology in oral treatment].

Dental turbine is a commonly used instrument for oral clinical treatment. However, there is usually suckback during the using of the traditional dental turbine, which causes the pathogen residue in the pipeline of the dental comprehensive treatment table, leading to cross-infection. Zero suckback technology is a new oral treatment technology to avoid suckback during the usage of dental turbine, which can reduce the possibility of cross infection. However, the applications and methods of zero suckback technique in oral therapy remain to be clarified. This consensus mainly provides guidance for the clinical standard application of zero suckback technology from following aspects: field and definition, indications, applicable population, personnel requirements, operating process and evaluation of therapeutic effect.

The dose received by patients during dental X-ray examination and the technical condition of radiological equipment.

BACKGROUND: Implementation of X-ray dental examination is associated with the patients exposure to ionizing radation. The size of the exposure depends on the type of medical procedure, the technical condition of the X-ray unit and selected exposure conditions. The aim of this study was to determine the dose received by patients during dental X-ray examination and the assessment of the technical condition of medical equipment, MATERIALS AND METHODS: The study included a total number of 79 dental X-ray units located in the region of Mazovia. The test methods for the assessment of the technical condition of dental X-ray units and measurement of radiation dose received by patients were based on the procedures elaborated in the Department of Radiation Hygiene and Radiobiology in the National Institute of Public Health - National Institute of Hygiene (Warszawa, Poland) accredited for the certification of compliance with PN-EN 17025. RESULTS: The research found that 69.6% fully meets the criteria set out in the Polish legislation regarding the safe use of ionizing radiation in medicine, while 30.4% did not meet some of them. A tenfold difference in the size of the dose received by patients during dental X-ray examinations was discovered. For example, during a radiography of the canine teeth of a child, the recorded entrance surface dose (ESD) ranged from 72.8 to 2430 microGy with the average value of 689.1 microGy. Cases where the dose reference level defined in Polish legislation of 5 mGy was exceeded were also found. CONCKUSIONS: It is essential to constantly monitor the situation regarding the technical condition of X-ray units which affects the size of the population's exposure to ionizing radiation as well as raising dentists' awareness about the effects of X-rays on the human body.

Impact of cooling on shaping ability of thermally treated files in canal models with double curvature.

Background: This study compared the ability of thermally treated files in shaping simulated canals with double curvature. Fifty-six canals were enlarged to a final size of 25 with ProTaper Next (PTN) or ZenFlex (ZF). Materials: Half of the samples were shaped with cooled files (n = 14 each). The amount of removed resin was measured and canal deviation was determined at eight levels. Shaping time and maximum shaping torque values were also recorded. Data were statistically analyzed using analysis of variance and LSD, Kruskal-Wallis, and chi-square tests at a 0.05 significance level. Results: Compared to PTN and cooled PTN, ZF and cooled ZF required lesser time to shape the canals. The maximum torques were found comparable between the groups. All the groups generated negligible deviations at every canal level evaluated and maintained the canal geometry. Although not significant, the cooled PTN and ZF files exhibited lesser canal deviations than their counterparts. Conclusion: All groups demonstrated similar shaping ability whilst maintaining the original curvature of the canal in simulated canals with double curvature. However, ZF groups were able to shape the canals faster than PTN groups. There was a trend that cooled files made lesser canal deviations compared to their counterparts.

Evaluation of an automated dental unit water system's contamination control protocol.

BACKGROUND: This study addresses the efficacy of an automated decontamination protocol using the germicide 'tetra acetyl ethylene diamine (TAED) perborate' (Farmec SpA, Italy). The germicide TAED perborate protocol is used in the Castellini Dental Units fitted with an Autosteril unit (an automated device that can cycle 0.26% TAED perborate solution and sterile water for cleaning the water system between patients and overnight). Prior to testing the Autosteril and the 0.26% TAED perborate protocol on the Logos Jr Dental Unit (Castellini SpA, Italy), TAED perborate was used on a dental unit water system simulation device. METHODS: A dental unit water system simulation device equipped with four dental unit water systems and with naturally grown and mature biofilm contamination was used in this study (three treatment units and one control). One treatment group used a simulated 5 minutes contact with TAED perborate and sterile water for irrigation; the second used a simulated 5 minutes contact with TAED perborate and 2 ppm ClO2 for irrigation; the third used a simulated 5 minutes contact with TAED perborate and municipal water for irrigation. The control group used municipal water for irrigation with no cleaning/disinfection protocols. This protocol was repeated for 30 cycles. Laser scanning confocal microscopy (LSCM) was used to study the effects on natural and mature biofilms, and R2A agar used to quantify heterotrophic plate counts in the effluent irrigant. Antimicrobial efficacy was evaluated by challenging TAED perborate with microbes and spores (M. smegmatis and B. subtilis). Deleterious effects of the germicide were evaluated on metal and nonmetal parts of dental unit water systems. Heterotrophic plate counts using R2A agar and LSCM of the lines were conducted to assess biofilm and microbial control. RESULTS: Baseline water samples showed mean contamination >5.6 log10 cfu/ml. After initial cleaning, all three groups maintained mean contamination levels of less than 1.1 (SD <0.3) log10 cfu/ml. LSCM of baseline samples was positive for live biofilm in all groups. At the end of the study, viable biofilm was only present in the control. In the microbial challenge test, all vegetative organisms were killed within 30 seconds of contact, while spores were killed within 5 minutes. Corrosion was seen in metals used in US-manufactured dental unit materials, while not observed in those used in the Castellini Logos Jr dental unit. CONCLUSION: In this study, the TAED perborate protocol was effective in biofilm control and control of dental treatment water contamination. Use of sterile water or 2 ppm ClO2 along with TAED treatment also controlled planktonic contamination effectively. CLINICAL SIGNIFICANCE: Environmental biofilms contaminate dental unit water systems over time and affect the quality of dental treatment water. Contaminants include environmental biofilms, microbes, including gram-negative rods and endotoxins in high doses that are not of acceptable quality for treating patients. There are many germicidal protocols for treating this contamination and one such is the prescribed use of TAED perborate used in conjunction with sterile water for irrigation in the autosteril device, an integral component of the Castellini dental units for between patient decontamination of dental unit water systems. This study was conducted on an automated simulation dental unit water system to test the TAED perborate protocol's efficacy on naturally grown, mature environmental biofilms, it's efficacy on microbes and spores and it's effects on materials used in dental unit water systems. This translational research addresses both microbial control and material effects of TAED perborate in studying efficacy and possible deleterious effects and simulated use in dentistry. Currently, this antimicrobial use protocol is followed worldwide in the Castellini dental units that are used in day-to-day dental patient care.

[Quality control testing of x-ray equipment used in medical diagnostic: results of interlaboratory comparison]. / Ocena pomiaru parametrów fizycznych w kontroli jakosci aparatury rentgenodiagnostycznej - wyniki miedzylaboratoryjnych badan porównawczych.

BACKGROUND: Effective diagnostic radiology system should be based on an efficient and suitable servicing of medical X-ray equipment. According to Polish requirements, all radiology departments are obligated to carry out quality control (QC) test of their X-ray set. In practice, testing is mostly performed by accredited external QC services, which have to participate in periodic interlaboratory comparison (ILC) to maintain or obtain the accreditation. Large-scale ILC for QC services were performed at the Nofer Institute of Occupational Medicine for three ranges of diagnostic radiology: dental, conventional and mammography. MATERIALS AND METHODS: During ILC, the metrological coherence of main physical parameters, which determine good quality of diagnostic image, were estimated and compared with appropriate reference values ensured by ILC organizer. The ILC participants comprised 29 QC services. The measurements were performed by ILC participants under laboratory conditions, using their own calibrated meters, according to routine procedures. All measurement results were assessed by calculating the E(n) value, normalized with respect to the uncertainties. RESULTS: Of the 328 evaluated results only 11 (3.4%) were classified as unsatisfactory. As much as 82% of them applied to mammography. Thus, the final evaluation revealed negative results in 2 of the 29 participants, which means that their satisfactory scores for the studied ranges were below 75%. CONCLUSIONS: In spite of predominant amount of satisfactory results, ILC indicated some regions of divergence e.g. large differences in evaluation of uncertainties and other inconsistencies.

A four-part setting on examining the anxiety-provoking capacity of the sound of dental equipment.

This paper reports the results of a four-part questionnaire survey to assess the effects of the sound of dental equipment on people's perceptions and dental anxiety levels. The convenience sample for the survey comprised 230 dental students and 230 gender and age matched non-dental university students. The subjects were requested to complete the questionnaires themselves. The results show that the sound of dental equipment has a great influence on dental anxiety. Dental students, who are more familiar with the operation of this equipment, are less prone to anxiety when they hear its sound than their non-dental counterparts.

Mobile Dental Delivery System: An Effective Protocol for Hygiene and Disinfection.

Mobile dental delivery systems (MDDSs) are receiving growing interest for reaching isolated patients, as well as in dental care for fragile and hospitalized patients, with the advantage of being able to be used from room to room or during general anesthesia (GA) in an operating room. Therefore, ensuring the care safety is crucial. The aim of this study was to elaborate and assess an MDDS maintenance protocol, containing the management of dental unit waterlines and adapted to specific conditions such as dental care under GA. A step-by-step protocol was established and implemented for an MDDS used during dental care under GA in children. Samples of the output water were collected at J0, J+1, 3, 6, 12, and 24 months, and cultured to observe the microbiological quality of the water. All the results (heterotrophic plate count at 22 °C, at 37 °C, and specific pathogenic germs sought) showed an absence of contamination. The protocol presented was effective over time and allowed ensuring the safety of care to be ensured when using MDDS, even during dental procedures under GA. As a result, it could be implemented by any dental care delivery structure wanting to reinforce the safety of its practice.

Patents on hospital medical and dental equipment (EMHO). Question and answer tool.

PURPOSE: To create a question and answer tool on patents on EMHO. METHODS: Was used the Thinking Design methodology divided into four phases: Discovery, Definition, Development and Delivery. Discovery Phase: Desk research was carried out in: SciELO, Pubmed, LILACS, Google and Google Scholar. Once the target audience was selected, the interviews were conducted. Definition Phase: the interviewees' difficulties were mapped, on an Excel spreadsheet. Development Phase: a brainstorming was conducted with the public interviewed. Delivery Phase: the prototype, validation and final elaboration of the tool were made. RESULTS: Discovery Phase: 10 inventors were identified and the interviews were carried out. Definition Phase: 80% of the interviewees determined lack of information as one of the problems. The main content was defined as: the patent process, from the beginning of the idea to the deposit (70%), search for precedence (40%) and informing partners (30%). Development Phase: with the brainstorming, the tool type was defined as an interactive site. Delivery Phase: a prototype with content framework and an interactive video was presented for validation. After approval, the interactive website was developed, which was made available to the public. CONCLUSION: A question and answer tool on patents in EMHO was developed.

Appropriate height of dental chairs for effective administration of chest compressions by female dentists.

Objectives: The aim of this study was to determine the appropriate height of a dental chair for the administration of effective chest compressions by female dentists. Materials and methods: We asked 19 female dentists to perform metronome-guided chest compressions at a rate of 100 compressions per minute for 2 min on the floor and on a dental chair. We set the height of the dental chair to 76, 73, 70, 67, and 64 cm. We measured the compression depth and proportion of compressions performed at an adequate depth. We then compared the quality of chest compressions between the tall and short (relative to the average body height) groups of participants. We also asked the participants to specify their preferred compression height or condition for chest compression administration. Results: The participants recorded their maximum chest compression depth (35.0 ± 8.8 mm) at a height of 67 cm. There was no significant difference in chest compression depth between the tall and short groups, irrespective of the compression height. The maximum depth of chest compressions was achieved at a height of 67 cm (from the floor to the compression surface) in both groups, with no significant difference. The participants most frequently identified 67 cm as the most suitable height for the administration of chest compressions. Conclusion: For female dentists, a height of 67 cm is considered suitable for the administration of chest compressions in the standing position, regardless of physique.

International standards and the dental practitioner.

The relationship between dental practice and international standards is described together with an account of the way in which standards are drafted and published. The United Kingdom participates in the process through the British Standards Institution, which is a Member Body of the International Standards Organization and the European Standards Committee. Some of the standards relevant to dental practice are quoted to demonstrate their importance. The principles of the regulatory processes used in Europe in relation to the Medical Device Directive and CE marking are discussed.

[Vision of the future of ergonomics in dentistry]. / Visie op de toekomst van de ergonomie in de tandheelkunde.

With respect to ergonomics in dentistry, more people are becoming aware of occupational hazards and paying more attention to the prevention of hazards. Dutch law on health and safety at work requires dentists to protect the health and safety of their employees and educational institutions to protect the health and safety of their students. In the meantime a summary has appeared of the ergonomic standards required for the working methods of dentists and for the development of future equipment. Further development of dental ergonomics must take place on the basis of a coherent vision of the future. In this regard it must be clear exactly what ergonomics is and what developments have already taken place. Aspects of particular interest are the prevention of occupational diseases, legal responsibility for protecting the health and safety of employees and students, education in dental ergonomics for dental and oral hygiene students, the academic development and research of dental ergonomics, using organizational models in daily dental practice, and the development of ergonomics at the European level.

Evaluating amalgam separators using an international standard.

BACKGROUND: Most amalgam particles generated during placement and removal of amalgam restorations are captured by chair-side traps and suction system traps and filters. Particles not captured can end up in the wastewater discharged from the dental office. Environmental initiatives to reduce the discharge of mercury-containing products such as dental amalgam waste into the environment have sparked interest in the use of amalgam separators. METHODS: The authors used International Organization for Standardization (ISO) Standard 11,143 for Amalgam Separators in a laboratory test to evaluate the amalgam removal efficiency of 13 commercially available amalgam separators and two commercially available filtration devices not marketed as amalgam separators but that have the potential to be used as such. RESULTS: All 13 amalgam separators and the two filtration devices exceeded the ISO Standard 11,143 requirement of 95 percent amalgam removal efficiency. The authors found statistical differences in the efficiency of the separators and filtration devices. No differences were found between the "empty" and "full" conditions for each separator. CONCLUSION AND CLINICAL IMPLICATIONS: This laboratory evaluation shows that amalgam separators and the filtration devices removed at least 97.05 percent of the amalgam in samples with particle-size distribution as specified in ISO Standard 11,143.

Evaluation of field dental equipment in a deployment environment.

Dental officers and technicians must have reliable, durable, well-performing field dental equipment to enable them to provide dental care to deployed troops in operational environments. Unfortunately, no organized program exists to test such equipment before its purchase and use in the field. This article presents the results of a project conducted by the Naval Institute for Dental and Biomedical Research and the Air Force Dental Evaluation and Consultation Service to evaluate commercially available field dental equipment through laboratory testing and clinical-user evaluations in theater. The purpose of this 2-year project was to identify the best-performing and most cost-effective field dental equipment for possible future procurement. Initial laboratory testing was performed at the Naval Institute for Dental and Biomedical Research, and the equipment was then shipped to Kuwait for in-theater environmental and clinical-user testing. A seven-member scientific team of military dental officers and technicians was deployed for 1 month to perform in-theater testing under regional environmental conditions and to coordinate clinical-user evaluations. The testing provided beneficial results by identifying equipment that performed properly and equipment that exhibited shortcomings serious enough to render it inadequate for operational use. It is recommended that the project serve as a model for future testing and evaluation of medical/dental equipment by all of the military services.

Propuesta del modelo para control de infecciones en la consulta odontológica ante la pandemia de COVID-19 / Proposal for an infection control protocol in the dental consultation against the COVID-19 pandemic

Catalogada su labor como Servicios de Salud Indispensables, el profesional de la odontología se ha mantenido al pendiente de sus pacientes durante la pandemia de COVID-19, brindando atención de urgencia a quien lo solicita. A su regreso a la práctica típica, el odontólogo encontrará un entorno distinto o NUEVA NORMALIDAD, viéndose obligado a hacer modificaciones clínicas pertinentes y preparar a su equipo de trabajo para continuar brindando atención de calidad con un margen de seguridad amplificado, que de igual manera proteja a pacientes y al equipo de trabajo. Ante la falta de una vacuna que brinde protección y de tratamiento específico contra el SARS-CoV-2 (COVID-19), elevar el nivel de control de infecciones en el consultorio se vuelve ineludible y posiblemente irreversible en el quehacer odontológico cotidiano. En este artículo se propone un Protocolo de Control de Infecciones en la consulta odontológica que permita brindar seguridad en la atención bucal, considerando COVID-19, útil también para control infeccioso de otros patógenos virales o bacterianos (AU)

Considered dentistry as an Indispensable Health Services, during the COVID-19 pandemic the dental professional has been providing mostly emergency care. Upon return to typical dental practice, the dentist will find a different environment or NEW NORMALLY, being forced to make relevant clinical modifications and prepare his team to continue providing quality care with an amplified safety margin, which equally protects patients and dental team. In the absence of an available vaccine that provides protection or a specific treatment against SARSCoV- 2 (COVID-19), raising the level of infection control at the dental office will become unavoidable and possibly irreversible in the future quotidian dental work. This article proposes an Infection Control Protocol for the dental consultation that allows provide safety oral care, considering COVID-19, also useful for other viral or bacterial pathogens control (AU)

Lineamientos de bioseguridad utilizados en las clínicas dentales periféricas de la Universidad de Monterrey durante la pandemia de COVID-19 / Biosafety guidelines used in the peripheral dental clinics of the University of Monterrey during the COVID-19 pandemic

El presente artículo tiene como propósito informar sobre los lineamientos que las clínicas dentales periféricas de la Escuela de Odontología de la Universidad de Monterrey (UDEM) han tomado frente a la pandemia actual COVID-19, emergente en la ciudad de Wuhan, China el pasado diciembre 2019. Dichas medidas surgen con el objetivo de cumplir con estándares de bioseguridad que eviten el contagio y/o la contaminación cruzada entre pacientes, profesionales y personal de las clínicas dentales de la UDEM; Clínica de Prevención Dental (CPD) y Clínica de Atención Dental Avanzada (CADA), las cuales permanecerán activas frente a situaciones que requieran atención de urgencia y postergando los tratamientos dentales de rutina. Los protocolos para brindar una atención de urgencia conllevan determinados pasos a seguir desde que el paciente ingresa a la clínica; iniciando con la revisión del expediente electrónico médico por medio de la plataforma Atlas.xp, seguido del llenado de un cuestionario enfocado al riesgo de la enfermedad y culminando con la toma de temperatura con termómetro infrarrojo. Los pacientes que no presenten síntomas y muestren una temperatura inferior a los 37.3 oC podrán ser atendidos bajo la aplicación de todas las medidas de bioseguridad establecidas (medidas de protección personal, de equipo y paciente, mantenimiento de dos metros de distancia en sala de espera, cumplimiento de tiempos de trabajo parciales, uso de lámparas purificadoras de aire distribuidas en las salas operatorias de las clínicas, trabajo asistido o a cuatro manos con la implementación de aislamiento absoluto en el paciente y con la utilización mínima de la pieza de alta velocidad). Asimismo, se menciona que posterior a cada tratamiento y en la culminación de la jornada laboral, todas las áreas y superficies deberán ser sanitizadas con sustancias desinfectantes específicas. Por su parte, el personal deberá portar ropa convencional al salir de las instalaciones y haber realizado un adecuado lavado de manos para evitar al máximo posible la transmisión del virus (AU)

The purpose of this article is to inform about the guidelines that the peripheral dental clinics of the School of Dentistry of the University of Monterrey (UDEM) have taken in the face of the current pandemic COVID-19, emerging in the city of Wuhan, China in the past December 2019. These measures arise with the aim of fulfilling biosafety standards that avoid contagion and/or cross contamination between patients, professionals and staff of UDEM dental clinics; Clínica de Prevención Dental (CPD) and Clínica de Atención Dental Avanzada (CADA), which will remain active in situations that require urgent care and postponing routine dental treatments. The protocols to provide urgent care include certain steps to follow from the moment the patient enters the clinic; starting with the review of the electronic medical record through the Atlas.xp platform, followed by the completion of a questionnaire focused on the risk of the disease and culminating with temperature measurement with an infrared thermometer. Patients who do not present symptoms and show a temperature below 37.3 oC may be treated under the application of all established biosecurity measures (personal, equipment and patient protection measures, maintenance of two meters in the waiting room, compliance with partial work times, use of air purifying lamps distributed in the operating rooms of the clinics, assisted or four-hand work with the implementation of absolute isolation in the patient and with the minimum use of the high-speed handpiece). It is also mentioned that after each treatment and at the end of the working day, all areas and surfaces must be sanitized with specific disinfecting substances. For their part, the personnel must wear conventional clothing when leaving the facilities and have carried out adequate hand washing to avoid transmission of the virus as much as possible (AU)