Risk of limb amputation and bone fractures with sodium glucose cotransporter-2 inhibitors: a network meta-analysis and meta-regression.

BACKGROUND: Sodium glucose cotransporter-2 inhibitors (SGLT2is) have gained immense attention for a variety of indications. Limb amputations (LA) and fractures were reported in clinical trials. This network meta-analysis and meta-regression were carried out to quantify the risks of these events. RESEARCH DESIGN AND METHODS: Randomized clinical trials evaluating SGLT2is and reporting patients developing LA/fracture were included. Odds ratios (OR) with 95% confidence intervals (95% CI) were the effect estimates. Sub-group analyses and meta-regression analysis were carried out. RESULTS: Ninety articles were included (LA: 36 studies; 96522 participants and fracture: 66 studies; 102,862 participants). An increased risk of LA (OR: 1.2; 95% CI: 1.1, 1.3) was observed. Amongst SGLT2is, canagliflozin was associated with increased risk of LA (OR: 1.6, 95% CI: 1.1, 2.4) while dapagliflozin with fracture (OR: 1.1, 95% CI: 1, 1.2). Sub-group analysis revealed increased risk of LA with an OR of 1.3 among those in the age group of > 40 to < 65, body-mass index of > 30 kg/m2, HbA1c category of > 7%, duration of diabetes of > 10 years, type 2 diabetes, and an OR of 1.2 for SGLT2is administration of > 6 months. CONCLUSIONS: SGLT2is were observed with an increased risk of LA. High- risk categories were identified for which precautions should be recommended in the standard treatment guidelines. PROTOCOL REGISTRATION: Open Science Framework (https://osf.io/5fwyk).

Enhancing readability of USFDA patient communications through large language models: a proof-of-concept study.

BACKGROUND: The US Food and Drug Administration (USFDA) communicates new drug safety concerns through drug safety communications (DSCs) and medication guides (MGs), which often challenge patients with average reading abilities due to their complexity. This study assesses whether large language models (LLMs) can enhance the readability of these materials. METHODS: We analyzed the latest DSCs and MGs, using ChatGPT 4.0© and Gemini© to simplify them to a sixth-grade reading level. Outputs were evaluated for readability, technical accuracy, and content inclusiveness. RESULTS: Original materials were difficult to read (DSCs grade level 13, MGs 22). LLMs significantly improved readability, reducing the grade levels to more accessible readings (Single prompt - DSCs: ChatGPT 4.0© 10.1, Gemini© 8; MGs: ChatGPT 4.0© 7.1, Gemini© 6.5. Multiple prompts - DSCs: ChatGPT 4.0© 10.3, Gemini© 7.5; MGs: ChatGPT 4.0© 8, Gemini© 6.8). LLM outputs retained technical accuracy and key messages. CONCLUSION: LLMs can significantly simplify complex health-related information, making it more accessible to patients. Future research should extend these findings to other languages and patient groups in real-world settings.

Assessing the Decision-Making Capabilities of Artificial Intelligence Platforms as Institutional Review Board Members.

Background: Institutional review boards (IRBs) face delays in reviewing research proposals, underscoring the need for optimized standard operating procedures (SOPs). This study assesses the abilities of three artificial intelligence (AI) platforms to address IRB challenges and draft essential SOPs. Methods: An observational study was conducted using three AI platforms in 10 case studies reflecting IRB functions, focusing on creating SOPs. The accuracy of the AI outputs was assessed against good clinical practice (GCP) guidelines. Results: The AI tools identified GCP issues, offered guidance on GCP violations, detected conflicts of interest and SOP deficiencies, recognized vulnerable populations, and suggested expedited review criteria. They also drafted SOPs with some differences. Conclusion: AI platforms could aid IRB decision-making and improve review efficiency. However, human oversight remains critical for ensuring the accuracy of AI-generated solutions.

DentalSegmentator: Robust open source deep learning-based CT and CBCT image segmentation.

OBJECTIVES: Segmentation of anatomical structures on dento-maxillo-facial (DMF) computed tomography (CT) or cone beam computed tomography (CBCT) scans is increasingly needed in digital dentistry. The main aim of this research was to propose and evaluate a novel open source tool called DentalSegmentator for fully automatic segmentation of five anatomical structures on DMF CT and CBCT scans: maxilla/upper skull, mandible, upper teeth, lower teeth, and the mandibular canal. METHODS: A retrospective sample of 470 CT and CBCT scans was used as a training/validation set. The performance and generalizability of the tool was evaluated by comparing segmentations provided by experts and automatic segmentations in two hold-out test datasets: an internal dataset of 133 CT and CBCT scans acquired before orthognathic surgery and an external dataset of 123 CBCT scans randomly sampled from routine examinations in 5 institutions. RESULTS: The mean overall results in the internal test dataset (n = 133) were a Dice similarity coefficient (DSC) of 92.2 ± 6.3 % and a normalised surface distance (NSD) of 98.2 ± 2.2 %. The mean overall results on the external test dataset (n = 123) were a DSC of 94.2 ± 7.4 % and a NSD of 98.4 ± 3.6 %. CONCLUSIONS: The results obtained from this highly diverse dataset demonstrate that this tool can provide fully automatic and robust multiclass segmentation for DMF CT and CBCT scans. To encourage the clinical deployment of DentalSegmentator, the pre-trained nnU-Net model has been made publicly available along with an extension for the 3D Slicer software. CLINICAL SIGNIFICANCE: DentalSegmentator open source 3D Slicer extension provides a free, robust, and easy-to-use approach to obtaining patient-specific three-dimensional models from CT and CBCT scans. These models serve various purposes in a digital dentistry workflow, such as visualization, treatment planning, intervention, and follow-up.

Genito-urinary infectious adverse events related to sodium glucose cotransporter-2 inhibitors: a network meta-analysis and meta-regression.

INTRODUCTION: Sodium glucose cotransporter-2 inhibitors (SGLT2is) are an emerging class of drugs with wide indications. Controversial evidence exists regarding the risk of urinary tract infection (UTI) and genital infections (GI) with SGLT2is paving way for undertaking this network meta-analysis and meta-regression study. METHODS: Data from randomized trials evaluating SGLT2is reporting the number of patients with UTI and GI were included. Odds ratios (OR) with 95% confidence intervals (95% CI) were the effect estimates. Meta-regression analysis identified risk factors. Number needed to harm (NNH) was estimated. RESULTS: Two hundred and sixty-four articles were included [UTI (213 studies; 150,140 participants) and GI (188 studies; 121,275 participants)]. An increased risk of UTI (OR: 1.11; 95% CI: 1.06, 1.16) and GI (OR: 3.5, 95% CI: 3.1, 3.9) was observed. Men showed a lower risk of UTI (OR: 0.2; 95% CI: 0.2, 0.3) and GI (OR: 0.4; 95% CI: 0.4, 0.5). Meta-regression analyses revealed BMI ≥ 30 kg/m2 and duration of SGLT2i treatment for ≥6 months as risk factors. NNH was 16 for UTI and 25 for GI. CONCLUSION: SGLT2is increase the risk of UTI and GI that needs to be incorporated in the treatment guidelines with precautions in high-risk patients. PROSPECTIVE PROTOCOL REGISTRATION: https://osf.io/5fwyk.

Intraclass comparison of inhaled corticosteroids for the risk of pneumonia in chronic obstructive pulmonary airway disorder: a network meta-analysis and meta-regression.

BACKGROUND: Inhalational corticosteroids (ICS) were observed to increase the pneumonia risk in chronic obstructive pulmonary airway disorder (COPD). However, it is unknown whether any differences exist between the drugs within the ICS class. AIM: This study aimed to evaluate the risk of pneumonia associated with different ICS and identify factors that predict pneumonia in patients with moderate-to-severe COPD using a network meta-analysis. METHOD: Electronic databases (Medline, Cochrane CENTRAL and Google Scholar) were searched for trials comparing ICS in COPD patients. The outcomes were pneumonia and serious pneumonia. Odds ratios (OR) with 95% confidence interval (95% CI) were estimated. Meta-regression was used to identify the predictors. The strength of evidence was graded using the Grading of Recommendations, Assessment, Development, and Evaluations approach. RESULTS: Sixty-six studies (103,347 participants) were included. Fluticasone (OR: 1.46; 95% CI: 1.26, 1.7), mometasone (OR: 2.2; 95% CI: 1.05, 4.6), and beclometasone (OR: 1.7; 95% CI: 1.1, 2.6) were observed with an increased pneumonia risk compared to placebo. Fluticasone (OR: 1.5; 95% CI: 1.3, 1.7) was observed with an increased risk of serious pneumonia. High doses (OR: 1.2; 95% CI: 1.03, 1.4), BMI ≥ 25 kg/m2 (OR: 1.6; 95% CI: 1.1, 2.2), and history of exacerbations in the preceding year predicted the pneumonia risk. Evidence strength was moderate. CONCLUSION: ICS class differences in pneumonia risk were observed in terms of pooled effect estimates but it is unlikely that any clinically relevant differences exist. Risk-benefit analysis supports ICS use in moderate-severe COPD.

Risk of Diabetic Ketoacidosis Associated with Sodium Glucose Cotransporter-2 Inhibitors: A Network Meta-Analysis and Meta-Regression.

Background: Sodium glucose cotransporter-2 inhibitors (SGLT2is) represent an emerging class of drugs with diverse indications. Despite their therapeutic potential, concerns regarding safety, particularly diabetic ketoacidosis (DKA), remain contentious, with uncertainty regarding differences among various SGLT2is. This study aimed to conduct a network meta-analysis and meta-regression to evaluate the risk of SGLT2i-induced DKA and associated factors. Methods: We systematically searched electronic databases for randomized clinical trials assessing SGLT2is across indications, reporting incidences of DKA. Mixed treatment comparison pooled estimates (MTCPEs) were calculated, and odds ratios (OR) with 95% confidence intervals (95% CI) served as effect estimates. We analyzed differences across dose categories (low, medium, and high) and conducted a meta-regression analysis to identify risk factors. The strength of evidence for key comparisons was determined. Results: Our analysis included 73 articles encompassing 85,997 participants assessing the risk of DKA. SGLT2is were associated with a heightened risk of DKA compared to placebo/control interventions (OR: 1.83; 95% CI: 1.35, 2.46), a finding confirmed by bootstrap analysis. Among SGLT2is, dapagliflozin (OR: 1.9; 95% CI: 1.17, 3.08), sotagliflozin (OR: 1.93; 95% CI: 1.14, 3.25), canagliflozin (OR: 1.11; 95% CI: 1.11, 12.45), and ertugliflozin (OR: 3.92; 95% CI: 1.04, 14.77) exhibited increased DKA risk. No significant differences were observed among specific SGLT2is. Sub-group analyses revealed a high risk of DKA with low (OR: 1.98; 95% CI: 1.3, 2.95) and high doses (OR: 2.4; 95% CI: 1.7, 3.3), type 1 diabetes (OR: 3.6; 95% CI: 1.6, 8.1), type 2 diabetes (OR: 1.6; 95% CI: 1.3, 2.4), as well as a diabetes duration exceeding 10 years (OR: 3.4; 95% CI: 1.1, 10.8). The evidence of certainty for most comparisons was moderate. Conclusions: SGLT2 inhibitors (SGLT2is) have been found to elevate the risk of DKA. The key factors that significantly predict the likelihood of DKA include the presence of diabetes (whether T1D or T2D) and the duration of diabetes. Based on these findings, standard treatment guidelines should advise taking specific precautions against DKA in patients identified as high-risk.

Leveraging artificial intelligence to detect ethical concerns in medical research: a case study.

BACKGROUND: Institutional review boards (IRBs) have been criticised for delays in approvals for research proposals due to inadequate or inexperienced IRB staff. Artificial intelligence (AI), particularly large language models (LLMs), has significant potential to assist IRB members in a prompt and efficient reviewing process. METHODS: Four LLMs were evaluated on whether they could identify potential ethical issues in seven validated case studies. The LLMs were prompted with queries related to the proposed eligibility criteria of the study participants, vulnerability issues, information to be disclosed in the informed consent document (ICD), risk-benefit assessment and justification of the use of a placebo. Another query was issued to the LLMs to generate ICDs for these case scenarios. RESULTS: All four LLMs were able to provide answers to the queries related to all seven cases. In general, the responses were homogeneous with respect to most elements. LLMs performed suboptimally in identifying the suitability of the placebo arm, risk mitigation strategies and potential risks to study participants in certain case studies with a single prompt. However, multiple prompts led to better outputs in all of these domains. Each of the LLMs included all of the fundamental elements of the ICD for all case scenarios. Use of jargon, understatement of benefits and failure to state potential risks were the key observations in the AI-generated ICD. CONCLUSION: It is likely that LLMs can enhance the identification of potential ethical issues in clinical research, and they can be used as an adjunct tool to prescreen research proposals and enhance the efficiency of an IRB.

The association between erosive toothwear and asthma - is it significant? A meta-analysis.

BACKGROUND: The association of asthma with oral conditions such as dental caries, dental erosion, periodontal diseases and oral mucosal changes has been the subject of debate among dental practitioners. Existing evidence indicates that an inhaler is the most common and effective way of delivering the asthma medications directly into the lungs. Few studies in the past attributed this association to the changes in salivary flow caused due to these medications. Considering this unclear association, the aim of the present meta-analyses is to identify the association between erosive toothwear and asthma from individual studies conducted until date. METHODOLOGY: Electronic databases were systematically searched until 30th September 2022. Articles identified using the search strategy were imported to RAYYAN systematic review software. Data was extracted relating to study design, geographic location, year of publication, sample size, the assessment method for erosive toothwear and asthma. The Newcastle Ottawa scale was utilized to assess the quality of evidence reported from the included studies. RevMan Version 5.3 was used to perform a random-effects meta-analysis to produce pooled estimates from OR and 95% CI of included studies. The I² statistic was used to determine the extent of heterogeneity. A funnel plot was generated to visually assess the potential for publication bias. Sensitivity analyses were performed by excluding individual studies one at a time. GRADE approach was used for grading the evidence for key comparisons. RESULTS: Twelve articles were included in the final meta-analysis. A total of 1027 asthmatics and 5617 non-asthmatics were included. All studies demonstrated moderate to low risk of bias. The overall pooled estimate (OR: 2.03; 95% CI: 0.96, 4.29) and subgroup analyses in children (OR: 1.67; 95% CI: 0.63, 4.42) did not show statistically significant difference in the occurrence of dental erosion between the asthmatic and non-asthmatic group. However, asthmatic adults had significantly greater dental erosion in comparison to the control adults (OR: 2.76; 95% CI: 1.24, 6.16). Sensitivity analyses also provided inconclusive evidence. Funnel plot asymmetry indicated significant heterogeneity, changes in effect size and selective publication. CONCLUSION: The association between inhalational asthmatic medication and tooth wear is inconclusive. There are a number of confounding factors that play a greater role in causing dental erosion in these patients. Dentist must pay particular attention to these factors while treating asthmatic patients. The authors produce a comprehensive checklist in order to ensure complete assessment before providing advice on their medications alone.

Use of Social Media to View and Post Dentistry-related Information in Bahrain: A Cross-Sectional Study.

OBJECTIVES: Healthcare-related information sharing via social media is on the rise following the coronavirus disease 2019 (COVID-19) pandemic. Dental practices primarily use social media to search, share, and communicate health-related information. Considering the increasing trend of using social media, the primary aim of the present study was to identify the use of social media by dentists and laypeople to post and view dentistry-related content in Bahrain. METHODS: This questionnaire-based cross-sectional study included adult participants and dentists. A pretested validated questionnaire was administered. The chi-square test for association was used to assess the association between categorical outcomes. A p-value of ≤ 0.05 was considered statistically significant. RESULTS: In total, 249 adult participants and 53 dentists were included. A substantial majority (83.5%) of the participants reported that they always used social media to view dentistry-related content, and 69.8% of the dentists felt that patients who use social media have better oral health awareness. A longer duration of social media usage showed significant associations with particularly viewing dentistry-related content (p = 0.008) and contacting dentists directly through social media for consultation (p = 0.055). CONCLUSIONS: An extremely high percentage of the younger population in Bahrain is using various social media to discuss dentistry. This engagement should be wisely managed to promote dentistry-related information sharing, which can lead to increased awareness related to overall dental health. There is a definite need to enforce certain standard operating procedures in every country that will prevent the misuse of this technological advancement.

Disinformation about COVID-19 Preventions and Treatments: Analysis of USFDA Warning Letters.

COVID-19 poses a challenge beyond the virus itself, in that lockdown has been associated increased use of the internet and social media. Disinformation about prevention and treatment strategies for COVID-19 can have lethal consequences. The United States Food and Drug Administration (USFDA) is currently monitoring the compliance of manufacturing firms as well as medicinal product advertisers to the Federal Food, Drug, and Cosmetic Act, 21 USC § 321(h) regulations. In the event of noncompliance in the form of advertising products without prior USFDA approval for specific indications, doses, or route of administration, warning letters (WLs) are issued. WLs are intended to address the concerns identified by USFDA and encourage the recipient to take corrective steps to avoid similar instances in the future. We analyzed 182 WLs that were issued for noncompliance with drugs/devices related to either treatment, prevention, or testing of COVID-19 infections. The medicinal product website was identified as the major source of disinformation, followed by disseminated information on Facebook, Twitter, and Instagram. Nearly four-fifths were related to drugs, followed by devices and biologicals. Several biologicals, as well as allopathic, herbal, and non-herbal drugs were identified in the WLs. We observed that noncompliance with the USFDA regulations in terms of advertising a variety of products for prevention and treatment of COVID-19 infection was widely prevalent. More efforts are required by the respective national drug regulatory authorities to initiate or continue their monitoring of disinformation that may have lethal consequences.

Oral side effects of locally delivered nicotine replacement therapy: A meta-analysis of randomized controlled trials.

BACKGROUND: Nicotine replacement therapy is the first choice pharmacotherapy for smoking cessation. Oral side effects caused due to NRT lead to discontinuation of treatment. The objective of this meta-analysis was to look for the certainty of evidence on the number of patients that reported oral side effects due to the use of NRT. METHOD: Eligible studies were selected and data extraction was carried out independently into a pre-tested data extraction form. Risk of bias was assessed using Cochrane Tool. The heterogeneity between the studies was assessed using Chi-square and I2 tests. Mean difference and Odds ratio at 95% confidence interval were the effect estimates. GRADE working group approach was used to assess the quality of evidence. RESULTS: Twenty-eight studies were included with moderate to low risk of bias. The pooled estimates revealed a statistically significant number of patients developed mouth or throat irritation (2.54 [1.23, 5.25]), or oral soreness (2.22 [1.40, 3.55]) or gastric reflux or vomiting (1.97 [1.34, 2.90]) due to NRT. CONCLUSION: It is important to understand that significant implications are caused due to NRT, on oral health. All patients on NRT must adhere to their regular dentist visits and must check their oral mucosa before initiating NRT.

Intrapleural thrombolytics for parapneumonic effusion: A network meta-analysis.

OBJECTIVES: Intrapleural thrombolytics have been trialed for facilitating pleural fluid drainage in patients with complicated parapneumonic effusion. The present study is a network meta-analysis of randomized clinical trials (RCTs) that have evaluated these thrombolytics. METHODS: Electronic databases (Medline, Cochrane CENTRAL, and Google Scholar) were searched for appropriate RCTs evaluating the therapeutic effect of thrombolytics in patients with complicated parapneumonic effusion. Mortality, proportion of patients referred for surgical intervention, and serious adverse events were the outcome measures. Random-effects model was used for generating direct and mixed treatment comparison pooled estimates. Grading of the evidence for key comparisons was carried out. Odds ratio with 95% confidence intervals was used for representing the pooled estimates. RESULTS: Seventy-six studies were retrieved with the search strategy of which 16 were included. No significant differences were observed for mortality. Compared to normal saline, significantly less proportion of patients was referred for surgical intervention with streptokinase (0.4, 0.2 to 0.8), urokinase (0.4, 0.2 to 0.8), alteplase (0.3, 0.1 to 0.7), and alteplase + DNase (0.2, 0.1 to 0.7). DNase alone increased the risk of referral to surgical intervention (3.4, 1.5 to 7.6). Only streptokinase was observed with increased risk of serious adverse events compared to normal saline (2.8, 1.1 to 7.1) and alteplase (6.7, 1.1 to 39.9). Moderate quality of evidence was observed for streptokinase with normal saline for the proportion of patients referred for surgical intervention while either low or very low quality strength was observed for all other comparisons. CONCLUSION: Streptokinase, urokinase, alteplase, and alteplase + DNase was observed with reduced proportions of patients referred for surgical interventions when used intrapleural in patients with parapneumonic effusion. Alteplase + DNase is likely to outperform others as it was observed with the least risk of patients referred for surgical interventions. Until additional data emerges that changes the pooled estimates, thrombolytics other than streptokinase are preferred due to increased risk of serious adverse events.

Preprocedural mouth rinses for preventing transmission of infectious diseases through aerosols in dental healthcare providers.

BACKGROUND: Aerosols and spatter are generated in a dental clinic during aerosol-generating procedures (AGPs) that use high-speed hand pieces. Dental healthcare providers can be at increased risk of transmission of diseases such as tuberculosis, measles and severe acute respiratory syndrome (SARS) through droplets on mucosae, inhalation of aerosols or through fomites on mucosae, which harbour micro-organisms. There are ways to mitigate and contain spatter and aerosols that may, in turn, reduce any risk of disease transmission. In addition to personal protective equipment (PPE) and aerosol-reducing devices such as high-volume suction, it has been hypothesised that the use of mouth rinse by patients before dental procedures could reduce the microbial load of aerosols that are generated during dental AGPs. OBJECTIVES: To assess the effects of preprocedural mouth rinses used in dental clinics to minimise incidence of infection in dental healthcare providers and reduce or neutralise contamination in aerosols. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 4 February 2022. SELECTION CRITERIA: We included randomised controlled trials and excluded laboratory-based studies. Study participants were dental patients undergoing AGPs. Studies compared any preprocedural mouth rinse used to reduce contaminated aerosols versus placebo, no mouth rinse or another mouth rinse. Our primary outcome was incidence of infection of dental healthcare providers and secondary outcomes were reduction in the level of contamination of the dental operatory environment, cost, change in mouth microbiota, adverse events, and acceptability and feasibility of the intervention. DATA COLLECTION AND ANALYSIS: Two review authors screened search results, extracted data from included studies, assessed the risk of bias in the studies and judged the certainty of the available evidence. We used mean differences (MDs) and 95% confidence intervals (CIs) as the effect estimate for continuous outcomes, and random-effects meta-analysis to combine data  MAIN RESULTS:  We included 17 studies with 830 participants aged 18 to 70 years. We judged three trials at high risk of bias, two at low risk and 12 at unclear risk of bias.  None of the studies measured our primary outcome of the incidence of infection in dental healthcare providers.  The primary outcome in the studies was reduction in the level of bacterial contamination measured in colony-forming units (CFUs) at distances of less than 2 m (intended to capture larger droplets) and 2 m or more (to capture droplet nuclei from aerosols arising from the participant's oral cavity). It is unclear what size of CFU reduction represents a clinically significant amount. There is low- to very low-certainty evidence that chlorhexidine (CHX) may reduce bacterial contamination, as measured by CFUs, compared with no rinsing or rinsing with water. There were similar results when comparing cetylpyridinium chloride (CPC) with no rinsing and when comparing CPC, essential oils/herbal mouthwashes or boric acid with water. There is very low-certainty evidence that tempered mouth rinses may provide a greater reduction in CFUs than cold mouth rinses. There is low-certainty evidence that CHX may reduce CFUs more than essential oils/herbal mouthwashes. The evidence for other head-to-head comparisons was limited and inconsistent.  The studies did not provide any information on costs, change in micro-organisms in the patient's mouth or adverse events such as temporary discolouration, altered taste, allergic reaction or hypersensitivity. The studies did not assess acceptability of the intervention to patients or feasibility of implementation for dentists.  AUTHORS' CONCLUSIONS: None of the included studies measured the incidence of infection among dental healthcare providers. The studies measured only reduction in level of bacterial contamination in aerosols. None of the studies evaluated viral or fungal contamination. We have only low to very low certainty for all findings. We are unable to draw conclusions regarding whether there is a role for preprocedural mouth rinses in reducing infection risk or the possible superiority of one preprocedural rinse over another. Studies are needed that measure the effect of rinses on infectious disease risk among dental healthcare providers and on contaminated aerosols at larger distances with standardised outcome measurement.

The variables associated with dental anxiety and their management in primary care dental clinics in Bahrain: a cross-sectional study.

BACKGROUND: 20-80% of adults presenting to a dental clinic experience anxiety. Negative past dental experiences and environmental factors such as the waiting area of a dental clinic or sound of a drill are commonly considered triggering factors for anxiety. Anxiety management strategies are considered a part of routine dental procedure, due to increased prevalence and compromised patient care. Hence the aim of the present study is to identify the prevalence and variables associated with dental anxiety and their management in patients visiting the primary care dental clinics in Bahrain. METHOD: Four hundred and eighty participants were included. A 3-part questionnaire deciphered the demographic characteristics of the participants, the dental procedure undertaken, the level of anxiety, and the management strategy used by the dentist. The pre and post-treatment MDAS scores were recorded. Paired t test, ANOVA and Wilcoxon signed rank test was used to test the level of significance between the variables and the mean MDAS scores. The p ≤ 0.05 was considered statistically significant. RESULTS: The prevalence of dental anxiety was 23.7% with moderate anxiety, and 11.4% with high anxiety. Females presented with a higher mean MDAS both pre and post-treatment compared with males. A statistically significant difference between the pre and post-treatment MDAS scores were observed in educated patients less than 50 years of age. Those with unpleasant previous dental experience showed statistically significant difference. Analyses of anxiety management techniques showed that single techniques worked better than combination techniques. Rest and breaks combined with any other technique of choice showed significant reduction in the MDAS scores post treatment. CONCLUSION: To conclude, all patients attending the dental clinic present with some level of anxiety that necessitates the dentist to use anxiety management strategies. Non-pharmacological methods that are non-invasive must be the first choice. Rests and breaks, with any technique of choice provides the best possible anxiety management. It is possible to achieve the desired anxiety reduction in single visit to complete the planned dental intervention, other than in patients who are dental phobic.

Prevalence of periodontitis in obese patients in Bahrain: a cross-sectional study.

BACKGROUND: Adult obesity has been associated with various systemic diseases and is an increasing problem in Bahrain. Recent evidence indicates a correlation between adult obesity and periodontitis. Hence the aim of this study was to assess the prevalence of periodontitis in overweight/obese adults in Bahrain and to determine the factors associated with periodontitis in these obese adults. METHOD: This cross-sectional study was conducted in overweight subjects attending Ministry of Health (MOH) Nutrition Clinics at primary health centers in Bahrain. After obtaining the institutional ethics approval, the demographic and anthropometric data, including Body Mass Index (BMI) and waist circumference (WC) using World Health Organization (WHO) thresholds for severity of obesity, were recorded. Periodontal status was measured using the Community Periodontal Index (CPI) and the extent and severity of periodontal disease were categorized according to the number of sextants with CPI codes 3 and 4. RESULTS: A total of 372 participated with a mean age 44.0 (± 10.5) years for males, and 42.5 (± 11.2) years for females. Periodontitis was present in 361 (97%) of participants. Hypertension and diabetes were the most prevalent co-morbidities at 23.4% and 16% respectively. Mean WC was significantly greater in males at 114 cm (± 15.6) compared to females 109.5 cm (± 12.5) (p < 0.001). BMI was not associated with severity or extent of periodontitis but WC was weakly correlated in males but not in females (Spearman rho = + 0.2, p < 0.05). In the logistic regression model using overall WC to predict the severity of periodontitis, the adjusted OR was 1.02 (95% CI 1.00-1.04) and for age it was 1.05 (95% CI 1.00-1.07). CONCLUSION: The prevalence of periodontitis was high in this sample of overweight Bahrainis. BMI was not correlated with periodontitis but WC had a weak positive correlation. Implementation of periodontal health screening as a routine part of a nutrition clinic program is recommended.

Topical corticosteroids for phimosis in children: a network meta-analysis of randomized clinical trials.

BACKGROUND: Corticosteroids and hyaluronidase are trialed for treating phimosis in children. We carried out the present network meta-analysis to compare the therapeutic effect of these drugs. METHODS: Electronic databases were searched for appropriate randomized clinical trials. Odds ratio (OR) with 95% confidence intervals (95% CI) was used as the effect estimate. A random-effects model was used for generating the pooled estimates. Rankogram plot was used for ranking the drugs. MAIN OUTCOME MEASURES: Proportions of patients with remission (partial/complete) and with complete remission. RESULTS: Mometasone (OR 6.53, 95% CI 2.85, 14.96), betamethasone/hyaluronidase (OR 12.1, 95% CI 4.27, 34.49), triamcinolone (OR 19.15, 95% CI 4.47, 81.96), dexamethasone (OR 21.38, 95% CI 5.71, 79.98), betamethasone (OR 23.02, 95% CI 6.92, 79.54), hydrocortisone (OR 23.2, 95% CI 5.91, 91.02) and methylprednisolone (OR 50.47, 95% CI 4.45, 572.72) were observed with significantly higher proportions of patients with remission (partial/complete) compared to placebo. Dexamethasone, triamcinolone, betamethasone, betamethasone/hyaluronidase, clobetasol, mometasone, and hydrocortisone were observed with significantly higher proportions of patients with complete remission compared to placebo. Beclomethasone was not observed to be superior to either placebo or other drugs. Rankogram plot revealed methylprednisolone followed by hydrocortisone had the maximum statistical probability of being 'the best' in the pool for remission and betamethasone followed by hydrocortisone for complete remission. CONCLUSION: Topical methylprednisolone, hydrocortisone, and betamethasone were observed with better clinical resolution of phimosis compared to other corticosteroids. Very high potent corticosteroids like beclomethasone and clobetasol were not observed with superior benefits compared to other corticosteroids. Considering low-potency, hydrocortisone shall be preferred until further evidence emerges.

Comparative assessment of interventions for treating cutaneous leishmaniasis: A network meta-analysis of randomized clinical trials.

INTRODUCTION: Various interventions including laser therapy, heat therapy, and several drugs have been trialed in patients with cutaneous leishmaniasis. Due to the lack of an evidence-based comparison of all these interventions, we carried out the present network meta-analysis. METHODS: Electronic databases were searched for randomized clinical trials evaluating the efficacy and safety of any interventions in patients with cutaneous leishmaniasis. The proportion of patients with complete cure was the primary outcome. The proportion of lesions cured at the end of treatment, the proportion of lesions with minimal/no response to treatment, and proportion of wounds with minimal/no change were the secondary outcomes. Random-effects modeling was used for generating pooled estimates. Rankogram plot was used for identifying the 'best intervention'. For interventions containing a combination of treatments, backslash (/) has been used for depicting the same. RESULTS: One-hundred and thirty-one studies were included. Intralesional meglumine, topical paromomycin/gentamicin, topical paromomycin, parenteral sodium stibogluconate, topical honey/intralesional meglumine, topical liposomal amphotericin B, oral zinc sulphate, oral miltefosine, parenteral meglumine, heat therapy, topical liposomal azithromycin, intralesional meglumine/silver dressing, intralesional sodium stibogluconate, parenteral meglumine/intralesional meglumine, oral allopurinol/parenteral meglumine, topical trichloroacetic acid/heat therapy, oral zinc sulphate/oral ketoconazole, topical imiquimod/cryotherapy, intralesional meglumine/cryotherapy, topical herbal extract of Z-HE, parenteral pentamidine, topical trichloroacetic acid/intralesional meglumine, carbon-dioxide laser, topical recombinant granulocyte-macrophage colony-stimulating factor/parenteral meglumine, intralesional dapsone, carbon-dioxide laser/intralesional meglumine, moist wet dressing with sodium hypochlorite, parenteral sodium stibogluconate/intralesional recombinant granulocyte-macrophage colony-stimulating factor, oral dapsone, intralesional sodium stibogluconate/oral ketoconazole, intralesional sodium stibogluconate/parenteral sodium stibogluconate and electrocautery/moist wet dressing with sodium hypochlorite were observed with significantly greater proportion of patients with complete cure compared to placebo/untreated controls. Rankogram analysis revealed that parenteral pentamidine has the highest statistical probability of being the best in the pool. CONCLUSION: We observed several interventions to be effective for treating cutaneous leishmaniasis. However, greater caution is required in interpreting the results as the estimates are likely to change with the advent of results from future studies.

Cerumenolytics with or without manual extraction for impacted earwax: A network meta-analysis of randomised clinical trials.

BACKGROUND: Many different substances for cerumenolysis have been evaluated in clinical trials. We carried out a systematic review and network meta-analysis to compare their effectiveness. METHODS: Electronic databases were searched for randomised clinical trials conducted in patients with impacted cerumen evaluating cerumenolytics. The primary outcome was the proportion of patients with wax clearance using manual techniques. Rankogram plot was used to assess the "best" cerumenolytic. Odds ratio (OR) with 95% confidence intervals (95% CI) was the effect estimate. RESULTS: Twenty-six studies were included in the systematic review and 25 in the meta-analysis. Sodium bicarbonate (OR: 2.68, 95% CI: 1.2, 6.1) and paradichlorobenzene (OR: 30.9, 95% CI: 5.9, 161.3) were associated with significantly greater proportions of patients with wax clearance following syringing compared to normal saline. Rankogram plot revealed paradichlorobenzene to have the highest probability of being the "best" cerumenolytic. Chlorobutanol was observed to be significantly better than normal saline in adults as well as following single application. Following multiple applications, glycerol, docusate sodium, hydrogen peroxide, oil, paradichlorobenzene, hydrogen peroxide/glycerol and arachis oil/chlorobutanol/paradichlorobenzene were observed with significant cerumenolytic activities. Urea/hydrogen peroxide/glycerol was observed with a significant cerumenolytic activity without the need for further interventions such as syringing/aspiration/suction. CONCLUSION: We observed several cerumenolytics to be effective in the treatment of impacted earwax when accompanied by additional manual techniques such as syringing/aspiration/suction.