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Objectives Culturable and unculturable microorganisms have been associated with periodontitis. Their differential proportions and composition have not been evaluated by their severity and complexity defined by stages in the 2018 AAP-EEP classification. Methods One hundred eighty subgingival biofilm samples were collected in Spain and Colombia from subjects categorized as health/gingivitis: periodontitis stages I/II periodontitis stages III/IV. Target culturable microorganisms (Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans, Tannerella forsythia, Treponema denticola, and Eubacterium nodatum) and target unculturable microorganisms (Filifactor alocis, Eubacterium saphenum, Eubacterium brachy, Desulfobulbus oralis) were evaluated by quantitative PCR analysis. In addition, their differences and association with periodontal status were analyzed by ANCOVA and logistic regression models once adjusted to age, current smoking, and country. Results P. gingivalis was significantly associated with periodontitis stages I/II, OR 2.44 (CI 95% 1.08–5.47) and stages III/V, OR 6.43 (CI 95% 2.43–16.9). T forsythia, OR 7.53 (CI 95% 2.07–27.4); D. oralis, OR 5.99 (CI 95% 2.71–13.23); F. alocis, OR 10.9 (CI 95% 4.56–23.2); E. brachy, 3.57 (CI 95% 1.40–9.11); and E. saphenum, 4.85 (CI 95% 1.99–11.7) were significantly associated only with stages III/IV periodontitis. P. gingivalis evidenced significant differences with the increase in the severity of the periodontal lesion: 2.97 colony forming unit (CFU)/μL (CI 95% 2.32–3.54) health/gingivitis, and 4.66 CFU/μL (CI 95% 4.03–5.30) and 5.90 CFU/μL (CI 95% 5.20–6.48) in stages I/II and III/IV respectively (p < 0.0001). Unculturable microorganisms only evidenced differences in concentration in stages III/IV compared with health-gingivitis (p ≤ 0.001). Conclusion Culturable and unculturable are strongly associated with stages III/IV periodontitis. Classic culturable microorganisms are more sensitive to differentiate between stages of periodontitis in the quantitative analysis. Clinical relevance Future interventional studies of periodontal disease should include Filifactor alocis, Eubacterium saphenum, Eubacterium brachy, and Desulfobulbus oralis as possible markers of therapy response and as indicators of progressive disease.

Background The objective was to qualitatively and quantitatively describe the subgingival cultivable bacteria in Albanian subjects and to compare it with a similar Spanish population. Materials and methods Consecutive patients, diagnosed as periodontitis in stages I–II or III–IV, and as periodontally healthy or with gingivitis, were studied clinically and microbiologically by means of microbiological culture, including total anaerobic counts, proportions, and frequency of detection of target species. Outcome variables were analysed by Mann–Whitney, Kruskal–Wallis, ANOVA, ANCOVA and Chi-square tests. Results In this cross-sectional study, 83 (Albania) and 90 (Spain) subjects were included. No statistically significant differences were observed between test and control populations regarding demographic variables or smoking habit. Significantly higher total anaerobic counts in the Albanian population (p = 0.022) were observed, especially in the periodontal health/gingivitis group (p = 0.001). In the test population, the proportions of the cultivable bacteria of Fusobacterium nucleatum were significantly lower in both the healthy/gingivitis (p = 0.022) and stages I–II periodontitis (p = 0.034) groups. Conclusions The subgingival cultivable bacteria in both periodontitis and non-periodontitis subjects from Albania showed significantly higher total anaerobic counts and lower proportions of the cultivable bacteria of F. nucleatum than a similar population of subjects from Spain.

The objective was to characterize and compare the subgingival microbiota in patients diagnosed according to the World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions 2018. For this cross-sectional study, Spanish and Colombian subjects (characterized as health/gingivitis, periodontitis in stages I-II or stages III-IV) were clinically assessed, and subgingival samples were taken and processed by culture. The comparisons among patients with periodontal status (and between countries) was made using Mann–Whitney, Kruskal–Wallis, ANOVA and chi-square tests. The final sample consisted of 167 subjects. Eikenella corrodens and Parvimonas micra were more frequently detected in health/gingivitis and Porphyromonas gingivalis in periodontitis (p &lt, 0.05). Higher total counts were observed in Colombia (p = 0.036). In Spain, significantly higher levels of P. gingivalis and Campylobacter rectus were observed, and of Tannerella forsythia, P. micra, Prevotella intermedia, Fusobacterium nucleatum, Actinomyces odontolyticus and Capnocytophaga spp. in Colombia (p &lt, 0.001). P. micra was more prevalent in health/gingivitis and stage I-II periodontitis in Colombia, and P. gingivalis in all periodontitis groups in Spain (p &lt, 0.05). As conclusions, significant differences were detected in the microbiota between health/gingivitis and periodontitis, with minor differences between stages of periodontitis. Differences were also relevant between countries, with Colombia showing larger counts and variability of bacterial species.

La metodología ApS pretende que el alumno aprenda a desenvolverse como un profesional capaz de identificar, resolver problemas, de comprender el impacto de su propia actuación profesional, de diseñar estrategias; y a la vez, ha de ser capaz de movilizar el conocimiento teórico que está adquiriendo en su formación dando un servicio a la comunidad.

Objetivo: Evaluar el acceso al mercado de los medicamentos huérfanos en España que a fecha de 31 de diciembre de 2017 tuvieran vigente su designación, y para aquellos comercializados en España estimar los tiempos entre la asignación de código nacional (CN) por parte de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) y la fecha de comercialización efectiva. Método: La base de datos para identificar los medicamentos huérfanos autorizados por la Agencia Europea de Medicamentos (EMA), a fecha 31 de diciembre de 2017 (n = 142), es su Registro Comunitario publicado por la Comisión Europea. La EMA publica los medicamentos huérfanos que han perdido la designación. Las fechas de asignación de CN provienen de la AEMPS, y las de comercialización, de Bot PLUS. Se llevó a cabo un análisis descriptivo de las variables de estudio. Las variables cuantitativas se describieron utilizando la media y mediana, así como la desviación estándar y su rango. Las variables cualitativas se describieron según frecuencias absolutas y relativas. La comparación de resultados se realizó mediante contrastes paramétricos y no paramétricos en función de la aplicabilidad, con un nivel de significación del 5%. Resultados: Entre 2002 y 2017, la EMA autorizó (con designación vigente a 31 de diciembre de 2017) 100 medicamentos huérfanos. De ellos, 86 tienen CN asignado, y de estos, 54 se han comercializado en España (54% de los medicamentos huérfanos vigentes y 63% de aquellos con CN). Para todos los medicamentos huérfanos con fecha de comercialización (53), el tiempo (mediana) desde la asignación del CN hasta su comercialización en España es de 13,4 meses (desviación estándar: 17,0; mínimo: 2,1; máximo: 91,7). La mediana para los comercializados en 2002-2013 y 2014-2017 es de 12,4 meses y 14,0 meses, respectivamente (p = 0,46). Esta diferencia no es estadísticamente significativa, lo que cabría esperar dado el número limitado de medicamentos huérfanos en nuestra «población». Conclusión: Numerosos factores determinan el acceso a los medicamentos huérfanos. La autorización centralizada de comercialización en Europa es un éxito; su acceso es más limitado, dadas las complejidades de evaluación de la evidencia disponible en los procesos de financiación y precio. Es necesario implementar nuevas políticas que reduzcan las desigualdades en el acceso y permitan la sostenibilidad del sistema. Para conseguir estos objetivos, podrían contemplar un proceso acelerado en la decisión de financiación y precio, y el pago por resultados con incertidumbre alta. Objective: To assess the access to orphan medicines in Spain, focusing on those with an active “orphan” designation, as of 31st December 2017; and for those orphan medicines in the Spanish market, estimate the time between being assigned a National Code (NC) by the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) and being approved for launch. Method: We used the European Commission's Public Register of orphan medicines to identify the orphan medicines authorised by the European Medicines Agency (EMA), as of 31 December 2017, while we sourced expired orphan indications from the EMA's website. Dates when NCs were assigned were sourced from the AEMPS, and commercialisation dates from Bot PLUS. A descriptive analysis of the study variables was done. The quantitative variables were described using means and medians, as well as standard deviations and ranges. The qualitative variables were described according to absolute and relative frequencies. The comparison of results was performed by parametric and non-parametric contrasts according to the applicability, at a 5% significance level. Results: The EMA has approved 100 orphan medicines (with designation as of 31/12/2017) between 2002-2017. Eighty-six have a NC assigned by the AEMPS. Fifty-four have been launched in Spain (representing 54% of the full sample; 63% with NC). For the 53 orphan drugs with launch date in Spain, the median time between receiving its NC and its launch is 13.4 months (standard deviation: 17.0; minimum: 2.1; maximum: 91,7). The median time is 12.4 months and 14.0 months for those medicines launched in Spain between 2002-2013 and 2014-2017 respectively (p = 0.46). This difference is not statistically significant, which is what could be expected given the low numbers of orphan medicines in the “population”. Conclusion: Complex factors determine the access to orphan drugs in Europe. The centralised procedure to obtain marketing authorisation at European level is a success. However, access is more limited, given the complexities of the evaluation of the available evidence for pricing and reimbursement decisions. It is therefore necessary to implement new policies that reduce inequalities in access and help achieve sustainable healthcare systems. To achieve this, they will need to offer the possibility of allowing earlier access, and using payment by results when there is high uncertainty. info:eu-repo/semantics/publishedVersion

Aim To evaluate the efficacy of a probiotic combination in the treatment of gingivitis and to assess its impact on the subgingival microbiota. Materials and Methods A placebo-controlled clinical trial was conducted in gingivitis subjects during 6 weeks. Test treatment consisted of the administration of two oral tablets per day containing the probiotic strains Lactobacillus plantarum, Lactobacillus brevis and Pediococcus acidilactici; the control group received the same tablets but without live bacteria. The main outcome variable was the changes in gingival index (GI). Subgingival samples were collected and analysed by quantitative polymerase chain reaction (qPCR) for five putative periodontal pathogens. Outcome variables were compared between and within groups, and multiple regression analysis was performed. Results A total of 59 patients (29 tests, 30 placebos) were included in the analysis. Both treatment groups experienced a statistically significant improvement in mean GI (p

Prebiotics and probiotics may have a role in the prevention and treatment of relevant oral diseases and conditions, including dental caries, periodontal and peri-implant diseases and halitosis. Prebiotics and probiotics may be associated with higher numbers or activity of “beneficial” bacterial species, thus controlling microbiological deleterious shifts, although the precise mechanisms of action have not been completely elucidated. For dental caries, most of the studies have not reported effects on caries incidence as a true endpoint. A beneficial effect has been observed in children with high caries-risk, while in low caries-risk children this positive effect is doubtful. In dental biofilm-induced gingivitis, most studies failed to find relevant clinical effects. In periodontitis therapy, the adjunctive use of probiotics has demonstrated relevant benefits in some studies, for with limited consistency. In peri-implant diseases, the available information is very limited, thus definitive conclusion cannot be made. In halitosis treatment, the limitations of the currently available therapies may lead to an important role of prebiotics/probiotics in the control of halitosis. Research is showing some promising results, but studies are needed to confirm this hypothesis.

To assess the access to orphan medicines in Spain, focusing on those with an active "orphan" designation, as of 31We used the European Commission's Public Register of orphan medicines to identify the orphan medicines authorised by the European Medicines Agency (EMA), as of 31 December 2017, while we sourced expired orphan indications from the EMA's website. Dates when NCs were assigned were sourced from the AEMPS, and commercialisation dates from Bot PLUS. A descriptive analysis of the study variables was done. The quantitative variables were described using means and medians, as well as standard deviations and ranges. The qualitative variables were described according to absolute and relative frequencies. The comparison of results was performed by parametric and non-parametric contrasts according to the applicability, at a 5% significance level.The EMA has approved 100 orphan medicines (with designation as of 31/12/2017) between 2002-2017. Eighty-six have a NC assigned by the AEMPS. Fifty-four have been launched in Spain (representing 54% of the full sample; 63% with NC). For the 53 orphan drugs with launch date in Spain, the median time between receiving its NC and its launch is 13.4 months (standard deviation: 17.0; minimum: 2.1; maximum: 91,7). The median time is 12.4 months and 14.0 months for those medicines launched in Spain between 2002-2013 and 2014-2017 respectively (p = 0.46). This difference is not statistically significant, which is what could be expected given the low numbers of orphan medicines in the "population".Complex factors determine the access to orphan drugs in Europe. The centralised procedure to obtain marketing authorisation at European level is a success. However, access is more limited, given the complexities of the evaluation of the available evidence for pricing and reimbursement decisions. It is therefore necessary to implement new policies that reduce inequalities in access and help achieve sustainable healthcare systems. To achieve this, they will need to offer the possibility of allowing earlier access, and using payment by results when there is high uncertainty.

Dentifrices are a general term used to describe preparations that are used together with a toothbrush with the purpose to clean and/or polish the teeth. Active toothpastes were first formulated in the 1950s and included ingredients such as urea, enzymes, ammonium phosphate, sodium lauryl sarcosinate and stannous fluoride. Later, therapeutic agents were included. Today's toothpastes have two objectives: to help the toothbrush in cleaning the tooth surface and to provide a therapeutic effect. The therapeutic effect may have an antiplaque or anti-inflammatory basis when the nature of the agents is antimicrobial. Plaque inhibitory and antiplaque activity of toothpastes used for chemical plaque control is evaluated in distinct consecutive stages, the last being home use randomized clinical trials of at least 6 months' duration. In this chapter, the scientific evidence supporting the use of the most common antiplaque agents, included in toothpaste formulations, is reviewed, with a special emphasis on 6-month clinical trials, and systematic reviews with meta-analyses of the mentioned studies. Among the active agents, the following have been included in toothpastes: enzymes, amine alcohols, herbal or natural products, triclosan, bisbiguanides (chlorhexidine), quaternary ammonium compounds (cetylpyridinium chloride) and different metal salts (zinc salts, stannous fluoride, stannous fluoride with amine fluoride). Dentifrices are the ideal vehicles for any active ingredient used as an oral health preventive measure since they are used in combination with toothbrushing, which is the most frequently employed oral hygiene method. The most important indications of dentifrices with active ingredients are associated with long-term use to prevent bacterial biofilm formation, mostly in gingivitis patients or in patients on supportive periodontal therapy.

Objective: To investigate the effects of an orally administered probiotic on the oral microbiota. Methods: A placebo-controlled, parallel study was conducted in 40 gingivitis subjects during 8 weeks. Treatment consisted on the administration of a daily tablet, either containing Lactobacillus reuteri or placebo. Unstimulated saliva and subgingival samples were collected and analysed by culture and PCR. Clinical and microbiological outcome variables were compared between and within groups. Results: There were no significant changes between and within the groups in the clinical variables. In saliva, total anaerobic counts after 4 weeks (p = 0.021) and counts of Prevotella intermedia after 8 weeks (p = 0.030), showed reductions in the test group. In subgingival samples, significant reductions in the changes baseline to 4 weeks were observed for P. gingivalis counts (p = 0.008). With PCR, L. reuteri ATCC-PTA-5289 was more frequently detected than L. reuteri DSM-17938. Conclusions: The effect of L. reuteri administered in tablets resulted in a reduction in the number of selected periodontal pathogens in the subgingival microbiota, without an associated clinical impact.