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Cardiovascular disease (CVD) is the leading cause of mortality worldwide, with 80% of that mortality occurring in low- and middle-income countries. Hypertension, its primary risk factor, can be effectively addressed through multisectoral, multi-intervention initiatives. However, evidence for the population-level impact on cardiovascular (CV) event rates and mortality, and the cost-effectiveness of such initiatives is scarce as long-term longitudinal data is often lacking. Here, we model the long-term population health impact and cost-effectiveness of a multisectoral urban population health initiative designed to reduce hypertension, conducted in Ulaanbaatar (Mongolia), Dakar (Senegal), and in the district of Itaquera in São Paulo (Brazil) in collaboration with the local governments. We based our analysis on cohort-level data among hypertensive patients on treatment and control rates from a real-world effectiveness study of the CARDIO4Cities approach (built on quality of care, early access, policy reform, data and digital, Intersectoral collaboration, and local ownership). We built a decision tree model to estimate the CV event rates during implementation (1–2 years) and a Markov model to project health outcomes over 10 years. We estimated the number of CV events averted and quality-adjusted life-years gained (QALYs through the initiative and assessed its cost-effectiveness based on the costs reported by the funder using the incremental cost effectiveness ratio (ICER) and published thresholds. A one-way sensitivity analysis was performed to assess the robustness of the results. The modelled patient cohorts included 10,075 patients treated for hypertension in Ulaanbaatar, 5,236 in Dakar, and 5,844 in São Paulo. We estimated that 3.3–12.8% of strokes and 3.0–12.0% of coronary heart disease (CHD) events were averted during 1–2 years of implementation in the three cities. We estimated that over the subsequent 10 years, 3.6–9.9% of strokes, 2.8–7.8% of CHD events, and 2.7–7.9% of premature deaths would be averted. The estimated ICER was USD 748 QALY gained in Ulaanbaatar, USD 3091 in Dakar, and USD 784 in São Paulo. With that, the intervention was estimated to be cost-effective in Ulaanbaatar and São Paulo. For Dakar, cost-effectiveness was met under WHO-CHOICE standards, but not under more conservative standards adjusted for purchasing power parity (PPP) and opportunity costs. The findings were robust to the sensitivity analysis. Our results provide evidence that the favorable impact of multisector systemic interventions designed to reduce the hypertension burden extend to long-term population-level CV health outcomes and are likely cost-effective. The CARDIO4Cities approach is predicted to be a cost-effective solution to alleviate the growing CVD burden in cities across the world.

Background When the dentist starts practicing independently, they need to plan and treat comprehensively and prioritise the procedures accordingly. This contrasts with dental students learning years where they deal with only a clinical subject during a fixed period. To improve this scenario a comprehensive dental care teaching clinic was introduced, and baseline assessment was performed. Methods The perceptions of patients, dental undergraduate students, clinical instructors, and clinic co-ordinators regarding Comprehensive Dental Care was evaluated by a cross sectional survey. The questionnaire was developed through a focus group discussion and content validation was performed by experts. Three domains including orientation to the clinics, clinical training of undergraduates and clinic management were assessed. Descriptive statistics were performed using SPSS. Results The results reveal, 53.5% of undergraduate students and 61.3% of clinic instructors agreeing that students trained under comprehensive system can confidently manage patients independently. Good collaboration (80%) among the dental team and regular monitoring of the clinic management (80%) were reported by clinic co-ordinators. The challenges ahead for this teaching clinic includes instrument and facilities availability, which has found to higher disagreement percentages by undergraduate students (43.7%), clinic instructors (38.7%) as well as clinic co-ordinators (50%). Patient satisfaction for all three domains were noted to be high. Conclusion With the introduction of the comprehensive dental care teaching clinic better patient management and improved clinical training of undergraduate students were reported by the stakeholders. This new system is a major shift in dental service delivery and can be adopted to similar settings to improve patient care and dental education.

Background: Burnout syndrome (BS) is related to work and is generally seen among health-care professionals including students. Students use various coping mechanisms to deal with stress and burnout and extracurricular activities are one among them. Aim: The aim of the study is to assess the burnout levels of dental students and its association with the indulgence in extracurricular activities (ECA). Materials and Methods: A cross-sectional questionnaire study was conducted among students of a deemed university dental school in south India. All the students from 1st year to 5th year (internship), both regular and supplementary batches were included. Maslach Burnout Inventory-Student Survey was used to assess burnout which consists of 15 items on three domains emotional exhaustion (EE), cynicism (CY), and professional efficacy (PE). All the responses were scored on a five point Likert scale. Mann–Whitney U-test and Poisson log-linear model were used. A P ≤ 0.05 was considered as statistically significant. Results: A total of 208 participants were included in the final analyses. Majority of the participants were females (84.1%) and 1st-year students (26.4%). The mean age of the participants was 20.6 ± 1.8 years. The prevalence of BS was 19.7%. A significant difference was seen for the participation in ECA and all the three domains (EE, CY, PE) of BS (P values 0.029, 0.004 and 0.006, respectively). Conclusion: The prevalence of burnout can be considered as high among the participants. Early screening for burnout in dental students and effective interventions at earlier stages is required.

Oral healthcare providers work near the face of the patients and are at an increased risk of being infected or transmitting the infection to the patients. Standard practice guidelines have to be modified to reorganize Oral Medicine care in the new normality of the COVID-19 pandemic to minimize the negative impacts of the infection on oral and systemic health. This scoping review aims to assess the guidelines for the safe practice of Oral Medicine during the COVID-19 pandemic. The literature search was done using Medline and Pubmed as the database and 23 articles were identified related to 8 domains. Utilization of teledentistry, efficient triaging of the patients with strict adherence to the infection control protocols, knowledge of the possible oral manifestations, and management of patients based on their presenting symptoms can help for the safe practice of Oral Medicine during the COVID-19 pandemic.

Leigh syndrome is a classical mitochondrial cytopathy with multisystemic presentation that can lead to death in the first few years of life; however, cases in adults have also been reported. In this study, we report the case of an adolescent female presenting with writer’s cramp associated with the MT-ND5 gene mutation, diagnosed after observation of brain abnormalities on magnetic resonance imaging (MRI) and biochemical changes suggestive of mitochondrial cytopathy. The patient responded to botulinum toxin injection. To the best of our knowledge, ours is the first case report on focal dystonic presentation associated with the MT-ND5 gene mutation (with unclear pathogenicity) as a mild form of Leigh syndrome in adolescents.

Objectives The use of Sclerostin Antibody(Scl-Ab) as a bone anabolic agent has shown significant benefit in bone disorders in preclinical animal models and human clinical trials. Currently available evidence on the use of Scl-Ab in alveolar bone regeneration is limited to animal studies and hence this scoping review encompasses the animal studies conducted to ascertain the effectiveness of Scl-Ab on alveolar bone regeneration. Materials and methods The search strategy was aimed to locate published animal studies in which the treatment arm includes Sclerostin antibody administration for alveolar bone preservation or regeneration. The search terms used were (((Animal model) OR Rodent) AND Alveolar bone defect) AND Anti sclerostin antibody) OR Sclerostin antibody) AND Alveolar bone regeneration) OR Bone regeneration) AND Bone fill. Results Of the 559 results from Medline/PubMed, Scopus, Web of Science, Google scholar and additional articles from the references, six were included in the review. Scl-Ab was found to be effective in improving the bone quality and quantity. It was also observed that Scl-Ab was useful in reduced bone density associated with diseases and conditiona affecting osteoblast activity. Conclusion The review concluded that Scl-Ab promotes alveolar bone augmentation and improves bone quality without surgical interventions.

COVID-19 causes a hypercoagulable state leading to thrombosis. Many of these thrombotic complications occur in those with severe disease and late in the disease course. COVID-19 has recently been associated with cerebral venous thrombosis (CVT).To study the onset of CVT in relation to COVID-19 and compare their characteristics and outcomes with non-COVID CVT patients admitted during the same period.This multicentric, retrospective study conducted between April 4 and October 15, 2020, included adult patients with CVT who were positive for the SARS-CoV-2 virus and compared them with CVT patients who were negative for the SARS-CoV-2 virus hospitalized during the same period. We studied their clinical profile, risk factors for CVT, and markers of COVID coagulopathy, imaging characteristics, and factors influencing their outcomes.We included 18 COVID-19-infected patients and compared them with 43 non-COVID-19 CVT patients. Fourteen patients in the COVID-19 group presented with CVT without the other typical features of COVID-19. Thirteen patients had non-severe COVID-19 disease. Twelve patients had a good outcome (mRS ≤2). Mortality and disability outcomes were not significantly different between the two groups.Our study suggests a possible association between COVID-19 and CVT. CVT can be the presenting manifestation of an underlying COVID-19, occurring early in the course of COVID-19 and even in those with mild disease. Patients with worse GCS on admission, abnormal HRCT chest, severe COVID-19, and need for invasive ventilation had a poor outcome.

A total of 20 bird species belongs to 7 orders and 11 families were recorded in Dharmadam estuary in Kannur district. The record of migratory bird Eurasian Curlew and two species near threatened birds within a short period of study and this record indicate that Dharmadam estuary may be attracting more number of migratory bird species. A long-term study is needed to understand the seasonal variation of the bird species in Dharmadam estuary in Kannur district.

Objectives: The health-care sector generates enormous amount of biomedical waste (BMW) and dental waste forms a subset of this hazardous waste. It is, therefore, imperative for the upcoming dental health professionals to be aware of the hazards related to improper waste management and the existing rules and regulations for the same. To gauge the gaps in knowledge and find ways to rectify the same, the aim of this study was to assess the knowledge, attitude, and practice of biomedical waste management among dental students. Materials and Methods: A cross-sectional study was carried out in a dental teaching hospital, wherein a pre-validated and tested, structured closed-ended questionnaire was adopted and given to the clinical students of dentistry. The responses were self-recorded by the participants after which statistical analysis was carried out using Chi-square test to compare the levels of knowledge, attitude, and practice among the study groups. Results: Out of 168 participants, 97% agreed that waste needs to be segregated but 70% were unaware of the legislations regarding BMW management. About half of the participants across all groups gave incorrect responses regarding correct disposal of various types of wastes. Only 10.1% of students correctly disposed mercury. Among the study groups, postgraduate students fared better than house surgeons and students. More than 90% of students believed that they required additional training in BMW management. Conclusion: An overall positive attitude was seen among all students toward safe management of BMW. However, their knowledge and practice toward the same calls for attention on the part of educational institutions in providing continuous educational programs and monitoring the correct disposal of wastes. This was validated by the fact that increase in educational qualification showed better performance toward this subject.

PurposeExtant literature on strategic environment analysis confirm broad evidence of studies on competences in the context of private sector organizations. Nevertheless, there is a growing interest and evidence of strategic competence in public sector organizations seeking to deliver improved performance. This paper attempts to determine the strategic competences of a National Health Service (NHS) unit for better organizational performance.Design/methodology/approachBased on the qualitative analysis of empirical evidence collected in a UK based NHS case study organization, we arrive at a strategic competence performance framework for the health unit using research carried out through interviews with employees and partner organization members.FindingsBy examining a UK-based qualitative case study, the proposed framework puts forward four strategic competence pillars vital for delivering organizational performance and effectively managing the environment of NHS unit's operations. The four strategic competences that are identified to foster NHS unit's performance are strategic leadership, staff engagement, knowledge transfer and partnership working.Originality/valueThe study examines the environment in which a UK based NHS health unit operates and identify the different strategic competences to deliver organizational performance.

Objective We designed this systematic review of the available literature to measure the pooled prevalence of periodontal disease among Indian adults. Methods An electronic search was conducted for studies assessing the prevalence of periodontal disease (gingivitis and periodontitis) in India. The search yielded forty studies, of which thirty eligible cross-sectional studies assessing the prevalence among those 18 years and above were included. The methodological quality of the included studies was assessed. Meta-analyses were conducted for periodontitis outcomes, stratified for different covariates like age groups, gender, geographic region, population group, type of index and study quality. Pooled prevalence was used to estimate overall effect, with 95% confidence intervals (CI). Results A total of 92,219 adults participated in 30 studies included for qualitative analysis. Studies utilizing convenience sampling were excluded from quantitative analysis. Pooled prevalence estimates of periodontitis and gingivitis were assessed on from 24 to 21 studies respectively. We found that overall prevalence of periodontal disease was 51% (CI: 41.9-60.1) and gingivitis was 46.6% (CI: 37.8-55.5). Prevalence of mild to moderate periodontitis was 26.2% (CI: 21.1-31.6), while for severe periodontitis it was 19% (CI: 14.3-24.2). Participants 65 years or above had highest proportion of severe periodontitis (32.7%, CI: 23.7-42.5). Urban population showed the highest prevalence of mild to moderate periodontitis 22.7% (CI: 17.3-28.5). Females had lower prevalence (34.4%) of the periodontitis than males (42.2%). The methodological heterogeneity of included studies was low. Conclusion Half of Indian adults suffer from some form of periodontal disease. There is need to adopt uniform and accurate measurement tools for recording periodontal condition.

SUMMARYConventional planar manipulators have their links in a single plane. Increasing payload at the end effector/mobile platform can induce high stress in the links due to the cantilever nature of links. Thus, it limits the total vertical load that can be applied on the mobile platform. In contrast to the links in conventional planar parallel mechanisms, non-planar links are proposed in this paper, that is, links are made inclined to the horizontal plane and non-planar legs are constructed. Though the links are made non-planar, the end effectors’ planar motion is retained. For studying the application of such non-planar links in planar manipulators, new models of inertia, stiffness and leg dynamics have to be developed. In this article, these models are developed by the static analysis of the planar manipulators with non-planar links, and the performance is compared with the corresponding conventional planar manipulators.

A study on the status and Diversity of birds in Government College Campus, Chittur, Palakkad, Kerala was conducted from July, 2018 to February, 2019. A total of 35 birds species belonging to 32 genera, 26 families and 9 orders were encountered. The results of the present study confirm the findings of previous studies that local vegetation and habitat characteristics such as densities of shrubs and mixed vegetation in the Govt. College Campus, Chittur influenced bird species richness anddiversity.

Aim: The aim of this review is to discuss the implications of COVID-19 on various aspects of dental care Background: The COVID-19 pandemic had suspended dental practice globally for over 3 months While dental practice is being resumed cautiously, standard infection control protocols that were traditionally overlooked are now being strictly implemented Post-COVID-19, dental care is expected to see a drastic change in the way it is practiced Review results: With a view on the natural history and disease dynamics of COVID-19, this review reports various aspects of dental care, viz , patient triaging, engineering and work practice controls, and administrative, fnancial, and ethical aspects of dental care during and after COVID-19 pandemic Current evidence-based recommendations with regard to infection-control practices are discussed A call for universal oral health care with suggestions regarding integration of medical and health care is also proposed Conclusion: COVID-19 is expected to be a watershed moment in the feld of dentistry While we expect to see positive changes in safe delivery of dental care, an increase in cost of availing care is imminent Clinical significance: The practice of dentistry and dental infection control has undergone dimensional changes due to bloodborne infectious diseases such as hepatitis B virus infections and human immunodeficiency virus epidemic Due to these pandemics, many regulatory organizations have provided safety recommendations and guidelines that impact the dental practice Currently, we are faced with a highly infective disease with a high mortality rate among people with comorbidities and of predominantly droplet transmission and no concrete safety recommendations and guidelines This manuscript addresses multiple issues, gaps, and pragmatic solutions in controlling transmission of SARS-CoV-2 in dental settings, during and after the pandemic © The Author(s) 2020 Open Access This article is distributed under the terms of the Creative Commons Attribution 4 0 International License (https://creativecommons org/licenses/by-nc/4 0/), which permits unrestricted use, distribution, and non-commercial reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made The Creative Commons Public Domain Dedication waiver (http://creativecommons org/publicdomain/zero/1 0/) applies to the data made available in this article, unless otherwise stated

Many different laboratory studies of adaptation to larval crowding in

IntroductionChildren’s learning abilities suffer when their oral health is compromised. Inadequate oral health can harm children’s quality of life, academic performance, and future success and achievements. Oral health problems may result in appetite loss, depression, increased inattentiveness, and distractibility from play and schoolwork, all of which can lower self-esteem and contribute to academic failure. An oral health curriculum, in addition to the standard school curriculum, may instil preventive oral hygiene behaviour in school students, enabling them to retain good oral health for the rest of their lives. Because most children attend school, the school setting is the most effective for promoting behavioural change in children. A ‘health-promoting school’ actively promotes health by enhancing its ability to serve as a healthy place to live, learn and work, bringing health and education together. Making every school a health-promoting school is one of the joint objectives of the WHO and UNICEF. The primary objective of this proposed study is to assess the effectiveness of an oral health curriculum intervention in reducing dental caries incidence and improving oral hygiene behaviour among high school children in grades 8–10 of the Ernakulam district in Kerala, India. If found to be effective in changing children’s behaviour in a positive way, an oral health curriculum may eventually be incorporated into the school health curriculum in the future. Classroom interventions can serve as a cost-effective tool to increase children’s oral health awareness.Methods and analysisThis protocol presents a cluster randomised trial design. It is a parallel-group comparative trial with two arms having a 1:1 distribution—groups A and B with oral health curriculum intervention from a dental professional and a schoolteacher, respectively. High schools (grades 8–10) will be selected as clusters for the trial. The minimum cluster size is 20 students per school. The total sample size is 2000 high school children. Data will be collected at three time points, including baseline, after 1 year (mid-term) and 2 years (final), respectively. The outcome measures are Decayed, Missing and Filled Teeth Index; Oral Hygiene Index-Simplified; and knowledge, attitude and behaviour. Data collection will be done by clinical oral examination and questionnaire involving oral health-related knowledge, attitude and behaviour items.Ethics and disseminationEthical approval was obtained from the Institutional Ethics Committee of Amrita Institute of Medical Sciences and Research Centre (dated 19 July 2022, no: IEC-AIMS-2022-ASD-179).Trial registration numberClinical Trial Registry of India (CTRI/2022/09/045410).

Background: Malignant otitis externa or skull base osteomyelitis arises as a complication of otological infection in immunocompromised individuals, especially elderly diabetics. With increasing awareness of the disease and better diagnostic modalities, there has been an increased reporting of atypical osteomyelitis of skull base (AOSB). Atypical osteomyelitis of skull base is a relatively rare yet an emerging clinical entity that also occurs in immunocompromised elderly individuals, however, in the absence of a pre-existing otological or rhinological infection. The purpose of this study was to review the clinical presentation and treatment protocol followed in patients diagnosed with atypical skull base osteomyelitis.Methods: A retrospective audit of medical records of patients diagnosed with AOSB between 2014 and 2018 was done. Clinical presentation and radiological assessment done prior to intervention was noted. All patients underwent transnasal endoscopic biopsy of tissue from clivus. Histopathological and microbiological profiling of biopsied tissue and treatment protocol followed was noted.Results: A total of 10 patients were included in the study out of which eight were male and two female. Eight patients were known diabetics and one patient had been on chronic oral steroid use. Majority presented with a vague dull aching headache and with one or more cranial nerve (CN) palsy(s). Radiological imaging showed clival involvement for all. All were managed conservatively with appropriate antibiotics. Disease resolution was defined as either complete resolution of symptoms and/or no residual lesion noted on follow-up MRI of skull base.Conclusions: Individuals presenting with non-specific symptoms of headache with CN palsy(s) with no obvious otological/rhinological infections, should raise suspicion of atypical skull base osteomyelitis. Histopathological diagnosis and microbiological assessment are an essential aid in conservative management with higher antibiotics. Patient compliance and long-term follow-up is essential for adequate and complete resolution of disease.

Mechanisms contributing to the onset and progression of Barrett's (BE)-associated esophageal adenocarcinoma (EAC) remain elusive. Here, we interrogated the major signaling pathways deregulated early in the development of Barrett's neoplasia.Whole-transcriptome RNA sequencing analysis was performed in primary BE, EAC, normal esophageal squamous, and gastric biopsy tissues (n = 89). Select pathway components were confirmed by quantitative polymerase chain reaction in an independent cohort of premalignant and malignant biopsy tissues (n = 885). Functional impact of selected pathway was interrogated using transcriptomic, proteomic, and pharmacogenetic analyses in mammalian esophageal organotypic and patient-derived BE/EAC cell line models, in vitro and/or in vivo.The vast majority of primary BE/EAC tissues and cell line models showed hyperactivation of EphB2 signaling. Transcriptomic/proteomic analyses identified EphB2 as an endogenous binding partner of MYC binding protein 2, and an upstream regulator of c-MYC. Knockdown of EphB2 significantly impeded the viability/proliferation of EAC and BE cells in vitro/in vivo. Activation of EphB2 in normal esophageal squamous 3-dimensional organotypes disrupted epithelial maturation and promoted columnar differentiation programs, notably including MYC. EphB2 and MYC showed selective induction in esophageal submucosal glands with acinar ductal metaplasia, and in a porcine model of BE-like esophageal submucosal gland spheroids. Clinically approved inhibitors of MEK, a protein kinase that regulates MYC, effectively suppressed EAC tumor growth in vivo.The EphB2 signaling is frequently hyperactivated across the BE-EAC continuum. EphB2 is an upstream regulator of MYC, and activation of EphB2-MYC axis likely precedes BE development. Targeting EphB2/MYC could be a promising therapeutic strategy for this often refractory and aggressive cancer.

Many different laboratory studies of adaptation to larval crowding in Drosophila spp. have all yielded the evolution of pre-adult competitive ability, even though the ecological context in which crowding was experienced varied across studies. However, the evolution of competitive ability was achieved through different suites of traits in studies wherein crowding was imposed in slightly different ways. Earlier studies showed the evolution of increased competitive ability via increased larval feeding rate and tolerance to nitrogenous waste, at the cost of food to biomass conversion efficiency. However, more recent studies, with crowding imposed at relatively low food levels, showed the evolution of competitive ability via decreased larval development time and body size, and an increase in the time efficiency of conversion of food to biomass, with no change in larval feeding rate or waste tolerance. Taken together, these studies have led to a more nuanced understanding of how the specific details of larval numbers, food amounts etc. can affect which traits evolve to confer increased competitive ability. Here, we report results from a study in which egg size and hatching time were assayed on three sets of populations adapted to larval crowding experienced in slightly different ways, as well as their low density ancestral control populations. Egg size and hatching time are traits that may provide larvae with initial advantages under crowding through increased starting larval size and a temporal head-start, respectively. In each set of populations adapted to some form of larval crowding, the evolution of longer and wider eggs was seen, compared to controls, thus making egg size the first consistent correlate of the evolution of increased larval competitive ability across Drosophila populations experiencing crowding in slightly different ways. Among the crowding-adapted populations, those crowded at the lowest overall eggs/food density, but the highest density of larvae in the feeding band, showed the largest eggs, on an average. All three sets of crowding-adapted populations showed shorter average egg hatching time than controls, but the difference was significant only in the case of populations experiencing the highest feeding band density. Our results underscore the importance of considering factors other than just eggs/food density when studying the evolution of competitive ability, as also the advantages of having multiple selection regimes within one experimental set up, allowing for a more nuanced understanding of the subtlety with which adaptive evolutionary trajectories can vary across even fairly similar selection regimes.

This systematic review and meta-analysis aimed to evaluate if bioceramic sealers had superior sealing properties to epoxy resin-based sealers.A systematic search was performed in the following databases: MEDLINE Ovid (from 1946 onwards), Scopus, Google Scholar, EBSCO, and a hand search of references of included articles was also done. In vitro and ex vivo studies were included. Risk of bias was assessed, and quantitative synthesis was performed for microleakage measured using vertical dye penetration, horizontal dye penetration, and dentin-sealer gap. Summary effect was reported as Standardized Mean Difference with 95% CI. Subgroup analysis was performed based on the imaging modalities, the obturation techniques, and the file systems employed.A total of 24 studies were included. Meta-analysis demonstrated no significant difference between the sealing ability of bioceramic sealer and epoxy resin-based sealer when measured using the microleakage tests [SMD -0.59(95%CI: 1.74,0.55)]. Subgroup analysis revealed no significant differences except when manual K-files were used. Heterogeneity was low when sub-group analysis was done.Bioceramic sealers and epoxy resin-based sealers both exhibited comparable sealing ability.

Introduction: Dental caries in the adult population that require preventive and therapeutic treatment are generally neglected in rural communities. The determination of the effectiveness of the application of 38% silver diamine fluoride (SDF) in arresting caries lesions when combined with atraumatic restorative treatment (ART) is very important, as it serves as a preventive and restorative procedure to regain the function of the permanent dentition. The assessment of optimal SDF application with ART, in comparison with ART alone, in managing cavitated carious lesions in a pragmatic setting, is the need of the hour to recommend optimal dental care, especially in rural settings which have minimal access to comprehensive dental care. Methods and Analysis: The clinical trial will enrol 220 adults (18–65 years) with cavitated carious lesions attending the Amrita School of Dentistry in the Ernakulam district, India. This study is a randomized, controlled trial with a 1:1 allocation ratio in two parallel groups. Study arm 1 will receive 38% SDF application and ART, and study arm 2 will receive ART only. A digital radiograph will be taken immediately after restoration (baseline) as well as at the end of the 6th month for evaluation of caries arrest. The assessment of the survival of the restoration will be done on the 7th day, 30th day, and at the end of the 6th month. The final analysis would include both the tooth and person levels. Ethics and Dissemination: This trial adheres to the principles of the Declaration of Helsinki and the guidelines of the Indian Council of Medical Research (ICMR). This study protocol has been approved by the Institutional Review Board. This trial has been registered prospectively with the Clinical Trial Registry of India (Registration No: CTRI/2021/12/038816).

Background: Real-world data on non-vitamin K oral anticoagulants (NOACs) are essential in determining whether evidence from randomised controlled clinical trials translate into meaningful clinical benefits for patients in everyday practice. RIVER (RIVaroxaban Evaluation in Real life setting) is an ongoing international, prospective registry of patients with newly diagnosed non-valvular atrial fibrillation (NVAF) and at least one investigator-determined risk factor for stroke who received rivaroxaban as an initial treatment for the prevention of thromboembolic stroke. The aim of this paper is to describe the design of the RIVER registry and baseline characteristics of patients with newly diagnosed NVAF who received rivaroxaban as an initial treatment. Methods and results: Between January 2014 and June 2017, RIVER investigators recruited 5072 patients at 309 centres in 17 countries. The aim was to enroll consecutive patients at sites where rivaroxaban was already routinely prescribed for stroke prevention. Each patient is being followed up prospectively for a minimum of 2-years. The registry will capture data on the rate and nature of all thromboembolic events (stroke / systemic embolism), bleeding complications, all-cause mortality and other major cardiovascular events as they occur. Data quality is assured through a combination of remote electronic monitoring and onsite monitoring (including source data verification in 10% of cases). Patients were mostly enrolled by cardiologists (n = 3776, 74.6%), by internal medicine specialists 14.2% (n = 718) and by primary care/general practice physicians 8.2% (n = 417). The mean (SD) age of the population was 69.5 (11.0) years, 44.3% were women. Mean (SD) CHADS2 score was 1.9 (1.2) and CHA2DS2-VASc scores was 3.2 (1.6). Almost all patients (98.5%) were prescribed with once daily dose of rivaroxaban, most commonly 20 mg (76.5%) and 15 mg (20.0%) as their initial treatment; 17.9% of patients received concomitant antiplatelet therapy. Most patients enrolled in RIVER met the recommended threshold for AC therapy (86.6% for 2012 ESC Guidelines, and 79.8% of patients according to 2016 ESC Guidelines). Conclusions: The RIVER prospective registry will expand our knowledge of how rivaroxaban is prescribed in everyday practice and whether evidence from clinical trials can be translated to the broader cross-section of patients in the real world. Funding: This work is supported by an unrestricted research grant from Bayer AG (Berlin, Germany) to the Thrombosis Research Institute (London, UK), which sponsors the RIVER registry. The funding source had no involvement in the data collection, data analysis or data interpretation.