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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.

The conditioning of the root canal wall during chemo-mechanical root canal treatment differentially affects the adhesion of root canal sealers. This investigation evaluated the impact of sodium hypochlorite (NaOCl) concentration as used in a root canal irrigation concept called continuous chelation, with 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) contained in the NaOCl solution that is applied. Fourier-transform infrared spectra of the dentinal wall were gathered. The consequential effects on push-out bond strength of an epoxy resin (AH Plus) versus a hydraulic CaSi sealer (BioRoot RCS) were assessed. Single-rooted extracted human teeth were used and irrigated with pure NaOCl at a concentration of 0% (physiological saline), 2.5%, or 5.25%. Dual Rinse HEDP (9%) was added to the solutions, or not added for further control. Pure NaOCl solutions caused a decrease in the amide III: phosphate ratios, which was counter-acted by the addition of HEDP. It was observed that the adhesion of the epoxy resin sealer under investigation was negatively affected by this NaOCl deproteinization of the canal wall in a dose-dependent manner, while the opposite was observed with the CaSi sealer. HEDP when used in conjunction with NaOCl was beneficial for the adhesion of both sealers.

The addition of Dual Rinse HEDP, an etidronate powder, to a sodium hypochlorite (NaOCl) solution can create a combined single endodontic irrigant with a soft tissue-dissolving and a decalcifying effect, which can replace traditional alternating irrigation with chemically non-compatible solutions. While the short-term compatibility between NaOCl and 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) has been shown, it remains unclear whether ultrasonic activation of a combined NaOCl & HEDP solution immediately reduces the available chlorine and/or renders the NaOCl ineffective in dissolving organic tissue remnants. This was tested in three experiments: (1) direct activation in test tubes in an ultrasonic bath and then the activation by an ultrasonically oscillating tip (IrriSafe) in (2) an epoxy resin model containing a simulated isthmus filled with gelatin, and (3) extracted teeth with simulated resorption cavities filled with soft tissue. The control solutions were physiological saline and 2.5% NaOCl without HEDP. In (1), available chlorine after 30 s of ultrasonic activation (37 kHz) of test and control solution was assessed, as well as shrimp tissue weight loss in direct exposure. In (2) and (3), the ultrasonic tip was driven at 1/3 of full power using the respective unit, and areas of removed gelatin from the isthmus and tissue weight loss were used as the outcomes, respectively. Experiment (1) revealed no negative impact by HEDP on available chlorine (1), while all three experiments showed a highly significant (p > 0.001) synergistic effect, which was not hampered by HEDP, between NaOCl and ultrasonic activation regarding tissue weight loss (1, 3) and dissolution of gelatin (2).

The aim of this study was to systematically review pulp wound lavage in vital pulp therapy (VPT). A search was conducted in six life science databases to identify clinical trials carried out on permanent teeth with a carious pulp exposure and a recall interval of at least six months. Twenty-seven trials of low to moderate risk of bias (RoB-2 and ROBINS-I) were included. Data was extracted and analyzed regarding study characteristics and methods used for pulp wound lavage. The agent used for pulp wound lavage was specified in all included trials. Most of the identified trials (23/27) randomized the pulp capping material. Many (14/27) reported the use of sodium hypochlorite (NaOCl); ten used only saline or water. One trial was identified that compared pulp wound lavage with 2.5% (NaOCl) to saline, another compared 5% glutaraldehyde to water, both in immature molar pulpotomies. Both studies were underpowered. Neither showed a significant difference between treatments. The use of NaOCl was positively correlated to recent year of publication and use of hydraulic calcium silicate cements for pulp capping (p < 0.05). In conclusion, despite a lack of well-designed trials on pulp wound lavage in VPT, a trend towards using NaOCl for this purpose was observed.

It has been speculated that the diluent used to test toothpaste abrasivity in standard tests may have an impact on their results, especially in the context of acidic toothpastes. This study tested whether an acidic toothpaste is indeed more abrasive than a neutral counterpart of otherwise identical composition, and whether this increased abrasivity is prevented by a buffered solution simulating saliva. Two experimental toothpastes of identical composition yet different pH (7.0 vs. 5.0) were prepared using standard ingredients. Subsequently, they were tested in standard absolute dentin abrasion and relative dentin abrasivity (RDA) experiments. To prepare slurries for these tests, deionized water as recommended by the International Organization for Standardization (ISO 11609:2017) was used, or a buffer solution containing bicarbonate and phosphate. The pH in these slurries was assessed and compared to the pH obtained in oral slurries of healthy individuals. Results showed that a significant (one-way ANOVA, p < 0.05) increase in mean absolute dentin abrasion and RDA values by 35 and 14%, respectively, was obtained when water was used as the diluent in conjunction with the acidic toothpaste as compared to the buffer solution. This was not the case with the neutral toothpaste. This result was explained by the finding that the buffer solution neutralized the pH in experimental slurries of the acidic toothpaste, while deionized water was unable to elevate the pH of the acidic toothpaste. That toothpaste was also neutralized in oral slurries. It was concluded that indeed the current ISO standard may result in a systematic overestimation of acidic toothpaste abrasivity.

The main biological goal in clinical dentistry remains to prevent micro-organisms from exerting pathogenic effects by establishing non-commensal biofilms or entering the wrong niches [...].

In this randomized controlled single-center clinical trial on 96 adult patients with parallel experimental groups (n = 48), the effects of washing a dentin/pulp wound in non-symptomatic teeth with extremely deep caries and pulpal exposure were compared between a 2.5% sodium hypochlorite (NaOCl) solution and a chemically-inert physiological saline control solution. After the allocated wound lavage, the pulps were capped with a mineral trioxide aggregate, covered by a glass-ionomer/resin liner, and the teeth were immediately restored with a resin-bonded-composite. In this first report, the early events were analyzed: postoperative discomfort (on an NRS-11 scale) at day-3 and -7 after intervention, and the occurrence of unbearable pain causing patients to contact the principal investigator to perform a root canal treatment (pulpectomy) during the first three months. The NaOCl solution caused a highly significant reduction in post-operative discomfort (p = 0.0010 day 3; p = 0.0007 day 7) and early painful failures (p = 0.0008) compared with the control. These novel findings highlight the importance of infection control in teeth with extremely deep carious lesions. Based on these observations, the use of an NaOCl solution to wash the exposed dentin/pulp wound in the vital pulp treatment is highly recommended in order to reduce pain and early failure.

Regenerative endodontics has been described as a paradigm shift in dentistry, despite its current limitation to immature teeth and reparative rather than regenerative outcomes. Cell-free treatments are favored because of regulatory issues. However, the recruitment of host-derived stem cells to the desired site remains challenging. We investigated whether dental pulp-derived exosomes, which are extracellular vesicles that contain proteins, lipids, RNA, and DNA and thus mirror their parental cells, may be used for this purpose. The use of exosomes may present appreciable advantages over the direct use of transplanted stem cells due to a higher safety profile, easier isolation, preservation, and handling. Here we harvested exosomes from a cultured third-molar pulp cell and assessed them by transmission electron microscopy and Western blotting. Human mesenchymal stem cells (MSCs) were exposed to these exosomes to assess exosome uptake, cell migration, and proliferation. In addition, a fibrin gel (i.e., a diluted fibrin sealant), was assessed as a delivery system for the exosomes. Our results show that exosomes attracted MSCs, and the fibrin gel enhanced their effect. Moreover, exosomes improved the proliferation of MSCs. Therefore, we propose that pulp-derived exosomes in combination with a fibrin gel could be a powerful combination for clinical translation towards improved cell-free regenerative endodontics and thus represent a new way to fill dental hard tissues.

This study investigated the effect of bioactive micro-fillers on the light transmittance and polymerization of three commercially available bulk-fill resin composites. These were mixed with 20 wt% bioactive glass 45S5, Portland cement, inert dental barium glass, or nothing (controls). Composites were photo-activated and light transmittance through 4 mm thick specimens was measured in real time. Moreover, degree of conversion (DC) and Knoop hardness (KHN) were assessed. Light transmittance of all bulk-fill composites significantly decreased (p < 0.05) with addition of 20 wt% bioactive glass 45S5 but not when inert barium glass was added. For bulk-fill composites modified with Portland cement, light irradiance dropped below the detection limit at 4 mm depth. The DC at the top surface of the specimens was not affected by addition of bioactive or inert micro-fillers. The bottom-to-top ratio of both DC and KHN surpassed 80% for bulk-fill composites modified with 20 wt% bioactive or inert glass fillers but fell below 20% when the composites were modified with Portland cement. In contrast to Portland cement, the addition of 20 wt% bioactive glass maintains adequate polymerization of bulk-fill composites placed at 4 mm thickness, despite a decrease in light transmittance compared to the unmodified materials.

The application of biomaterials used in regenerative endodontics should be traceable. In this study, we checked some basic effects of rendering a fibrin hydrogel radiopaque using an iodine-based contrast agent (iodixanol) approved for systemic application. Fibrin hydrogels were prepared from a fibrin sealant (Tisseel) using either an isotonic iodixanol solution (Visipaque 320, test) or Tris buffer (control) as a diluent. Gelation kinetics, radiopacity, and swelling of lyophilized hydrogels were tested using standard methods. Hydrogel structure was evaluated using scanning electron microscopy (SEM). Furthermore, iodixanol release from the test gels was assessed using spectrophotometry, and tissue compatibility was compared between test and control hydrogels using the chick chorioallantoic membrane (CAM) assay. Results were compared using pairwise t-test, p < 0.05. Iodixanol caused a 70-fold delay in gelation to 26 min in the test compared to the control hydrogels (22 ± 1 s). Radiopacity of the test gels was 1.9 ± 0.2 mm Al/mm, compared to zero in the control hydrogels. Lyophilized hydrogel swelling was strongly reduced when iodixanol was added to the hydrogel (p < 0.05). Test hydrogels had an altered SEM appearance compared to controls, and exhibited a reduced porosity. Iodixanol release from the test hydrogels reached 14.5 ± 0.5% after 120 h and then ceased. This release did not have any apparent toxic effect and neither affected the viability, nor the physiology or vascularization of the CAM of fertilized chicken eggs. Iodixanol can render a fibrin hydrogel radiopaque and maintains its tissue compatibility, yet impacts gelation kinetics and hydrogel porosity.

BACKGROUND Ectopic tissue has been observed frequently in human root canal specimens when cell homing studies were performed at the dorsum of rodents. In contrast, pulp-like tissue formed when immature teeth were implanted on top of the rat calvaria. It was surmised, yet not tested, that the implantation site might affect tissue ingrowth. METHODS Four root sections from human immature molars cleaned with 5% sodium hypochlorite (NaOCl) followed by 17% ethylenediaminetetraacetic acid (EDTA) were implanted per rat (n = 5). Two specimens were placed at the dorsum (control), while the other two specimens were implanted at the calvaria. After 6 weeks, the specimens were investigated for histological structure, immunoreactivity to dentine sialoprotein (DSP) and bone sialoprotein (BSP), per-area percentage of tissue ingrowth, and gene expression (DSPP, COL1, NGF and VEGF). Data were statistically compared. RESULTS Tooth specimens placed at the calvaria generally showed pulp-like tissue and odontoblast-like cells at the dentinal wall where DSP and BSP immunoreactivity were intense. The area of tissue ingrowth was significantly larger in the specimens placed at the calvaria compared to those placed at the dorsum. DSPP was the only gene that was upregulated significantly when specimens were implanted at the calvaria. CONCLUSION Our findings suggest that the calvarial site is superior to the dorsum to study pulp regeneration in human teeth in the rat.

The goal of this narrative review was to summarize and compare treatment options for permanent teeth carious lesions that are radiographically close to the pulp chamber. Thanks to adhesive restorative materials, minimally invasive approaches are possible. In this context, the old question arises as to whether caries must be excavated completely, i.e., down to hard dentin, or whether it could be advantageous to leave some soft dentin, or even merely seal the whole lesion. To answer this question, the microbiological aspects of the lesion must be considered, along with the immunological response in the dental pulp, with the concurrent possible negative outcomes for the patient. Both aspects are considered in this review, and clinical studies comparing different treatment modalities are discussed. Situations in which calcium silicate cements could be advantageous over the gold standard calcium hydroxide preparations for covering the dentin/pulp wound are also discussed.

Contemporary endodontics has seen an unprecedented advance in technology and materials. This article aimed to review some of the challenges and advances in the following sections: (1) endodontic imaging, (2) root canal preparation, (3) root canal disinfection, (4) root canal filling, and (4) regenerative endodontic procedures (REPs). Jointly, these advances are aimed at improving the state of the art and science of root canal treatment.

Flame spray synthesis has opened the possibility to add additional elements to complex materials such as bioactive glasseswhile maintaining nanoparticulate properties. In this study, it was investigated whether a flamesprayed bismuth oxide doped nanometric 45S5 bioactive glass could be incorporated into a commercially available epoxy-resin root canal sealer, and how this compared to a conventional, pure 45S5 micrometric bioactive glass. Effects on radiopacity, microhardness, pH and mineral induction in phosphate buffered saline and simulated body fluid were studied. It was revealed that the radiopaque nanometric bismuth-containing 45S5 bioactive glass reduced radiopacity of the root canal sealer less than a conventional micrometric counterpart. In addition, pH induction and calcium phosphate precipitation were quicker with the nanometric compared to the micrometric material, whilst the micrometric glass displayed a higher alkaline capacity. Both materials apparently bound to the epoxy resin matrix, thus increasing its microhardness after polymerization reaction. Effects were dose-dependent. The investigated radiopaque bioactive glass containing bismuth oxide could be a valuable add-on for current root canal sealers.

AIM To assess two contemporary rotary instrumenting systems subjectively and objectively in a pre-clinical student course setting. METHODOLOGY Undergraduate dental students (n = 44) prepared mesiolingual canals of 3D-printed mandibular molar replicas (RepliDens, Zurich, Switzerland). The HyFlex and BioRace rotary systems, both previously unknown to the students, were used according to the manufacturers' guidelines after a short theoretical introduction. For comparison, a first-generation rotary system (ProFile .04), which the students knew from their previous education, was then used in a third RepliDens. Questionnaires were issued to note subjective experiences immediately after instrumentation. Objectively, time to instrument to size 40, .04 taper and shaping outcomes were analysed. Categorical data were compared using chi-square and Fisher's exact tests, numerical data according to goodness of fit to the normal distribution, P < 0.05. RESULTS Subjectively, the students liked the file size and sequence designation in the BioRace system significantly (P < 0.05) better than in the HyFlex counterpart, whilst they found better controllability with the HyFlex (P < 0.05), and reported no difference in cutting efficiency. They preferred both systems to the ProFile. Objectively, canal transportation was significantly less with the HyFlex (and the ProFile) systems compared to BioRace (P < 0.05). Both systems under investigation were statistically similar in terms of file fractures (nil), length control, and instrumentation time, which was considerably faster than with the ProFile control system. CONCLUSIONS HyFlex and BioRace had perceived and quantifiable strengths and weaknesses. Both systems were equally liked by the students and preferred over the ProFile first-generation rotary system.