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A new regulation for the marketing and application of medical devices has become applicable in the European Union as of May 2021. This regulation is termed EU 2017/745 or Medical Device Regulation (MDR). Initially published and entered into force in 2017, it replaces the former Medical Device Directive 93/42/EEC (MDD), but is still under amendment. The implication of this legislation has broad effects on manufacturers, importers, distributors, users of medical devices, and patients. This article discusses the MDR from the dental perspective. As is illuminated in this text, the MDR will create more red tape for industrial players to get their products CE (Conformitée Européenne) marked, and more documentation work for dentists. This also means that smaller companies acting out of Europe are affected in a disproportionally negative manner compared to their globally acting counterparts. The MDR could and most probably will result in a considerable reduction and price increase of the products that are available to European dentists. Moreover, the MDR could create a rift between dental materials scientists working at universities and the dental industry, because the latter now has to direct more money towards regulatory affairs rather than product development or innovation. On the other hand, the MDR may also act as an antetype for similar regulations in other parts of the world, and could offer new career opportunities for individuals in dental materials research, especially in the regulatory field.

INTRODUCTION The in vitro efficacy of irrigant activation devices has not been contrasted to their safety. This was attempted in this study using apically closed versus patent simulated root canal systems in epoxy resin models, with the latter featuring a simulated periapical lesion. METHODS All 72 models had 2 joining canals connected by an isthmus, which was filled with dentin debris. The simulated periapical lesion was filled with colored gelatin in the 36 respective models. Canals were irrigated with 1.3% sodium hypochlorite. Samples were divided into 4 subgroups per system (n = 9): conventional irrigation, sonic low (EndoActivator; Dentsply Sirona, Charlotte, NC) and high frequency (EDDY; VDW, Munich, Germany), and ultrasonic agitation of the irrigant (always applying 3 cycles of 20 seconds). The total cleared surface areas (mm$^{2}$) in the simulated isthmus and periapical lesion were compared between systems and devices using parametric tests (P < .05). RESULTS The cleaning of the isthmus was more effective in the apically open compared with the closed systems and was also significantly influenced by the agitation method (P < .001). In the closed systems, EDDY and ultrasonic agitation achieved the significantly (P < .05) best cleaning of the isthmus. In the open systems, ultrasonic agitation showed the single best result (P < .05). EDDY caused by far the highest and ultrasonic agitation the lowest dissolution of the gelatin in the simulated periapical lesion. CONCLUSIONS Under the conditions of this study, ultrasonic agitation of a previously administered sodium hypochlorite irrigant was more laterally targeted and thus safer and more effective than sonic agitation methods.

Im sich stetig ändernden und verschärfenden regulatorischen Umfeld der Zahnmedizin werden auch medikamentöse oder andere temporäre Wurzelkanaleinlagen respektive die hierfür verwendeten Produkte immer wieder neu hinterfragt und zum Teil ganz abgeschafft. In diesem Artikel werden die relevanten Veränderungen diskutiert und ein einfaches klinisches Konzept mit chemisch kompatiblen Wirkstoffen als Expertenmeinung vorgestellt.

In this retrospective study, it was investigated whether the use of a fifth-generation rotary system (ProTaper Next) resulted in improved radiological root filling quality compared to a first-generation counterpart (ProFile) in a controlled student course setting. Cases treated by fourth-year dental students in the 2020/21 academic year were collected and compared to those treated in 2019/20. Root canals in the former group were all instrumented using the ProTaper Next system, and the latter using the ProFile system. All other clinical parameters were similar between the two academic years, including the time of pre-clinical teaching, hands-on course hours, endodontic auxiliaries, and chemicals used for treatment. After excluding patients who were not available or refused to give their informed consent to this study (n = 20), and excluding teeth with missing or poor radiographs (n = 16), the fillings in 178 roots could be assessed by two calibrated observers blinded to the system that was used. The primary outcome was the radiographic quality of the root fillings according to the five-scale modified MOLANDER score. The secondary outcome was the number of separated rotary instruments by group. Both instrumenting systems resulted in a similar number of "excellent" root fillings (score I), 59 % in the ProTaper Next group and 60% in the ProFile group, with no statistically significant difference in outcome scores between groups (Probability > ChiSquare = 0.70). Furthermore, there was merely one separated instrument in the ProTaper Next group, and none in the ProFile group (Fisher's exact test, p = 1.00).

Aim: To assess whether persistent idiopathic dentoalveolar pain (PIDAP), a diagnosis of exclusion, exhibits common features that can facilitate its diagnosis. PIDAP is defined by the International Classification of Orofacial Pain (ICOP 6.3.) as 'Persistent unilateral intraoral dentoalveolar pain, rarely occurring in multiple sites, with variable features but recurring daily for more than 2 h per day for more than 3 months, in the absence of any preceding causative event'. Methodology: In this observational study, participants fulfilling the new ICOP diagnostic criteria of PIDAP were included, covering 16 years of consecutive data. A systematic, retrospective assessment of patients utilizing the new PIDAP criteria on complaints of chronic tooth pain in a referral-based endodontic practice was undertaken. Non-idiopathic cases were excluded on the basis of clinical and radiologic findings. A modified neuropathic pain questionnaire was used to describe the painful sensations. Furthermore, allodynia in the periodontal space and sensory changes in the oral mucosa were assessed using a periodontal probe. Results: Amongst the 160 patients assessed, 78 (63 women) fulfilled the strict PIDAP criteria. Pain history of PIDAP included no nocturnal awakening (85%) and a 'pulling/dragging' pain quality (59%). In 69% of the patients with PIDAP, pain was associated with a root filled tooth at the same site. In 14% of the cases, no endodontic treatment was performed in the affected quadrant. Mechanical allodynia in the gingival sulcus was observed in 91% of patients with painful teeth or implants. Conclusions: In this observational study, PIDAP mainly affected females and was associated with undisturbed sleep and periodontal allodynia. Keywords: International Classification of Orofacial Pain; endodontic diagnostics; persistent idiopathic dentoalveolar pain

The authors of this narrative review aimed to address various experimental methods and make recommendations for how research should move forward in the context of studying biomarkers in clinical Endodontic research. The approach adopted is exemplified using two prominent clinical problems, namely (a) the ‘reversible’ versus ‘irreversible’ pulpitis conundrum and (b) persistent idiopathic dentoalveolar pain (PIDAP). Pulpitis under deep caries or dentinal cracks is understood from a histological perspective, but clinical assessment tools to indicate irreversibly inflamed aspects of the dental pulp are elusive. PIDAP, on the other hand, is a diagnosis of exclusion; its pathophysiology is complex and not understood sufficiently to avoid unnecessary dental treatments. This review addresses how diagnostic biomarkers could further our understanding of those and other clinical problems, and how issues can be tackled from a methodological point of view. Hence, different methodological approaches to identify suitable diagnostic biomarker(s) or use known biomarkers are presented. The importance of asking a relevant research question, collecting the most suitable fluid and using the ideal collection vehicle for the research question under investigation is discussed based on the defined clinical problems.