Breast cancer awareness among women of reproductive age- a questionnaire based study.

INTRODUCTION: Breast cancer is the most frequent cancer in women worldwide, and its prevalence is rising among younger women of reproductive age. The study aims to investigate their awareness of breast cancer risk factors, warning indicators, and preventive methods. The study also aimed to assess participants' knowledge of breast self-examination (BSE) and their practices with this crucial screening method. METHODOLOGY: To achieve these goals, we used a cross-sectional survey employing a structured questionnaire. The questionnaire included multiple-choice and open-ended items about breast cancer awareness, knowledge, and practices. RESULTS: There were 400 questionnaires given out to female patients attending the out-patient department, and 290 of them were completed and returned. The majority of responders to our poll, 88 %, were aware that breast cancer is the most frequent cancer in women. The fact that 57 % of the individuals never examined their own breasts is a worrying result. There was a statistically significant difference between knowledge and family history (X2 = 13.8, P < 0.001) and knowledge and schooling (X2 = 6.4,P < 0.001). Both the practise of BSE and knowledge of BC were good in respondents under the age of 45, however they differed statistically significantly (X2-2.8,P = 0.041 and X2-2.6, P = 0.001, respectively). CONCLUSION: Understanding the extent of breast cancer awareness and knowledge gaps in this population is critical for planning targeted interventions and educational efforts. By identifying areas where knowledge is weak, healthcare practitioners and governments can implement policies to encourage early detection practices, reduce delays in seeking medical aid, and ultimately improve breast cancer outcomes.

Phase III randomized clinical studies to evaluate the immunogenicity, lot-to-lot consistency, and safety of ROTAVAC® liquid formulations (ROTAVAC 5C & 5D) and non-inferiority comparisons with licensed ROTAVAC® (frozen formulation) in healthy infants.

The WHO pre-qualified rotavirus vaccine, ROTAVAC®, is derived naturally from the neonatal 116E rotavirus strain, and stored at -20°C. As refrigerator storage is preferable, immunogenicity and safety of liquid formulations kept at 2-8°C, having excipients to stabilize the rotavirus, with or without buffers, were compared with ROTAVAC® in different clinical studies. Study-1, the pivotal trial for this entire product development work, was a randomized, single-blind trial with two operationally seamless phases: (i) an exploratory phase involving 675 infants in which two formulations, ROTAVAC 5C (LnHRV-1.5 mL and LnHRV-2.0 mL) containing buffer and excipients to stabilize the virus against gastric acidity and temperature, were compared with ROTAVAC®. As the immune response of ROTAVAC 5C (LnHRV-2.0 mL) was non-inferior to ROTAVAC®, it was selected for (ii) confirmatory phase, involving 1,302 infants randomized 1:1:1:1 to receive three lots of LnHRV-2.0 mL, or ROTAVAC®. Primary objectives were the evaluation of non-inferiority and lot-to-lot consistency. The secondary objectives were to assess the safety and interference with the concomitant pentavalent vaccine. As it was separately established that buffers are not required for ROTAVAC®, in Study-2, the safety and immunogenicity of ROTAVAC 5D® (with excipients) were compared with ROTAVAC® and lot-to-lot consistency was assessed in another study. All lots elicited consistent immune responses, did not interfere with UIP vaccines, and had reactogenicity similar to ROTAVAC®. ROTAVAC 5C and ROTAVAC 5D® were immunogenic and well tolerated as ROTAVAC®. ROTAVAC 5D® had comparable immunogenicity and safety profiles with ROTAVAC® and can be stored at 2-8°C, leading to WHO pre-qualification.Clinical Trials Registration: Clinical Trials Registry of India (CTRI): CTRI/2015/02/005577CTRI/2016/11/007481 and CTRI/2019/03/017934.

Safety and immunogenicity of a new formulation of a pentavalent DTwP-HepB-Hib vaccine in healthy Indian infants-A randomized study.

BACKGROUND: Pentavalent vaccines (DTP-HepB-Hib) have been introduced in many countries in their routine public immunization programmes to protect against diphtheria (D), tetanus (T), pertussis (P), hepatitis B (Hep B) and Hemophilus influenzae type b (Hib) diseases. This study compared the safety and immunogenicity of a new formulation of a whole-cell Bordetella pertussis (wP) based pentavalent vaccine (DTwP-HepB-Hib). The new formulation was developed using well-characterized hepatitis B and pertussis whole cell vaccine components. METHODS: This was a phase III, observer-blind, randomized, non-inferiority, multi-center study conducted in India among 460 infants who were followed up for safety and immunogenicity for 28 days after administration of three doses of either investigational or licensed comparator formulations at 6-8, 10-12 and 14-16 weeks of age. RESULTS: The investigational formulation of DTwP-HepB-Hib vaccine was non-inferior to the licensed formulation in terms of hepatitis B seroprotection rate (% of subjects with HepB antibodies ≥10mIU/mL were 99.1% versus 99.0%, respectively, corresponding to a difference of 0.1% (95% CI, -2.47 to 2.68)) and pertussis immune responses (adjusted geometric mean concentrations of antibodies for anti-PT were 76.7 EU/mL versus 63.3 EU/mL, with a ratio of aGMTs of 1.21 (95% CI, 0.89-1.64), and for anti-FIM were 1079 EU/mL versus 1129 EU/mL, with a ratio of aGMTs of 0.95 (95% CI, 0.73-1.24), respectively). The immune responses to other valences (D, T, and Hib) in the two formulations were also similar. The safety profile of both formulations was found to be similar and were well tolerated. CONCLUSIONS: The investigational DTwP-HepB-Hib vaccine formulation was immunogenic and well-tolerated when administered as three dose primary series in infants. CLINICAL TRIAL REGISTRATION: Clinical Trials Registry India number: CTRI/2018/12/016692.

The potential impact of COVID-19 on women's reproductive and mental health: a questionnaire study.

The pandemic has transformed the social and economic certainties of people's lives imposing stay-at-home necessities which began in mid-March 2020. This cross-sectional observational study was performed to study the impact of COVID-19 on the reproductive and mental health of women before and after the pandemic. A digital survey form of 50 questions was developed using the Google platform andshared over 4 weeks in August 2021. Paired t-test was used to compare the variables before and after the COVID-19. Of the 450 respondents, 443(98.44%) completed the questionnaire. There was a significant difference in the average duration of menstruation and the proportion of women with a cycle length of 35-45 days increased from 5 to 8% of women after the pandemic. Painful periods (28.5 to 59.5%, p = .002) and weight increased (39.2%, p < .001) after the pandemic. Stress also increased after the pandemic (p < .001). The pandemic has significantly impacted the reproductive and mental health of women. The long-term health significances of this are yet to be determined.Impact StatementWhat is already known on this subject? The pandemic has transformed the social and economic certainties of people's lives, mainly women. Women's health significantly mental health is affected by the lack of adequate domestic and emotional support which may further consequences like the risk of anxiety and depression.What do the results of this study add? Our study shows the effect of COVID-19 on women's reproductive and mental health before and after the pandemic. Inadvertent forfeits women's health and well-being and instabilities in reproductive function as raised pressure causes irregularities in the menstrual cycle.What are the implications of these findings for clinical practice and/or further research? Women have suffered from significant mental and reproductive problems during the first and second waves of the COVID-19 pandemic. But, the long-term effects of these are not unknown. Upcoming work should comprise study throughout the pandemic and the long-term impact on women's health.

Persistence of immunity and impact of third dose of inactivated COVID-19 vaccine against emerging variants.

This is a comprehensive report on immunogenicity of COVAXIN® booster dose against ancestral and Variants of Concern (VOCs) up to 12 months. It is well known that neutralizing antibodies induced by COVID-19 vaccines wane within 6 months of vaccination leading to questions on the effectiveness of two-dose vaccination against breakthrough infections. Therefore, we assessed the persistence of immunogenicity up to 6 months after a two or three-dose with BBV152 and the safety of a booster dose in an ongoing phase 2, double-blind, randomized controlled trial (ClinicalTrials.gov: NCT04471519). We report persistence of humoral and cell mediated immunity up to 12 months of vaccination, despite decline in the magnitude of antibody titers. Administration of a third dose of BBV152 increased neutralization titers against both homologous (D614G) and heterologous strains (Alpha, Beta, Delta, Delta Plus and Omicron) with a slight increase in B cell memory responses. Thus, seronversion rate remain high in boosted recipients compared to non-booster, even after 6 months, post third dose against variants. No serious adverse events observed, except pain at the injection site, itching and redness. Hence, these results indicate that a booster dose of BBV152 is safe and necessary to ensure persistent immunity to minimize breakthrough infections of COVID-19, due to newly emerging variants.Trial registration: Registered with the Clinical Trials Registry (India) No. CTRI/2021/04/032942, dated 19/04/2021 and on Clinicaltrials.gov: NCT04471519.

Pharmacological consideration of COVID-19 infection and vaccines in pregnancy.

COVID-19 is a pandemic of the 21st century that recorded 234 809 103 confirmed cases and more than 4 800 375 deaths. Many studies report the effect of COVID-19 in the overall population; nevertheless, there is information scarceness related to pharmacological management and pregnancy and fetal outcomes during the epidemic. Pregnancy is a state of change in immune physiology and anatomy modulation in preference to immune suppression. Additionally, manifold interactions with the health care system during pregnancy increases the chance of infection, and managing, pregnant population poses a more significant challenge. This review will summarize the available data on pharmacological considerations and vaccines in pregnancy and their adverse effects on fetal outcomes. Several drug choices include but are not limited to antivirals and antimalarial and combinations, corticosteroids, nonsteroidal anti-inflammatory drugs, and antipyretics. Approved vaccines for pregnancy include Pfizer/BioNTech and mRNA-1273 Moderna/National Institutes of Health. COVID-19 treatment approaches vary across different countries; the WHO and the Centers for Disease Control and Prevention guidelines and country regulators advise managing adverse effects on pregnancy and fetal outcome. But the efficacy of these drugs is questionable. There is no adequate literature to demonstrate the safety of these drugs in pregnant and lactating women. Hence, well-conducted studies that assess the safety of anti-COVID-19 medications and vaccines in pregnancy and lactating women are needed.

Efficacy, safety, and lot-to-lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): interim results of a randomised, double-blind, controlled, phase 3 trial.

BACKGROUND: We report the clinical efficacy against COVID-19 infection of BBV152, a whole virion inactivated SARS-CoV-2 vaccine formulated with a toll-like receptor 7/8 agonist molecule adsorbed to alum (Algel-IMDG) in Indian adults. METHODS: We did a randomised, double-blind, placebo-controlled, multicentre, phase 3 clinical trial in 25 Indian hospitals or medical clinics to evaluate the efficacy, safety, and immunological lot consistency of BBV152. Adults (age ≥18 years) who were healthy or had stable chronic medical conditions (not an immunocompromising condition or requiring treatment with immunosuppressive therapy) were randomised 1:1 with a computer-generated randomisation scheme (stratified for the presence or absence of chronic conditions) to receive two intramuscular doses of vaccine or placebo administered 4 weeks apart. Participants, investigators, study coordinators, study-related personnel, the sponsor, and nurses who administered the vaccines were masked to treatment group allocation; an unmasked contract research organisation and a masked expert adjudication panel assessed outcomes. The primary outcome was the efficacy of the BBV152 vaccine in preventing a first occurrence of laboratory-confirmed (RT-PCR-positive) symptomatic COVID-19 (any severity), occurring at least 14 days after the second dose in the per-protocol population. We also assessed safety and reactogenicity throughout the duration of the study in all participants who had received at least one dose of vaccine or placebo. This report contains interim results (data cutoff May 17, 2021) regarding immunogenicity and safety outcomes (captured on days 0 to 56) and efficacy results with a median of 99 days for the study population. The trial was registered on the Indian Clinical Trials Registry India, CTRI/2020/11/028976, and ClinicalTrials.gov, NCT04641481 (active, not recruiting). FINDINGS: Between Nov 16, 2020, and Jan 7, 2021, we recruited 25 798 participants who were randomly assigned to receive BBV152 or placebo; 24 419 received two doses of BBV152 (n=12 221) or placebo (n=12 198). Efficacy analysis was dependent on having 130 cases of symptomatic COVID-19, which occurred when 16 973 initially seronegative participants had at least 14 days follow-up after the second dose. 24 (0·3%) cases occurred among 8471 vaccine recipients and 106 (1·2%) among 8502 placebo recipients, giving an overall estimated vaccine efficacy of 77·8% (95% CI 65·2-86·4). In the safety population (n=25 753), 5959 adverse events occurred in 3194 participants. BBV152 was well tolerated; the same proportion of participants reported adverse events in the vaccine group (1597 [12·4%] of 12 879) and placebo group (1597 [12·4%] of 12 874), with no clinically significant differences in the distributions of solicited, unsolicited, or serious adverse events between the groups, and no cases of anaphylaxis or vaccine-related deaths. INTERPRETATION: BBV152 was highly efficacious against laboratory-confirmed symptomatic COVID-19 disease in adults. Vaccination was well tolerated with no safety concerns raised in this interim analysis. FUNDING: Bharat Biotech International and Indian Council of Medical Research.

Enhanced visualization of the root canal morphology using a chitosan-based endo-radiopaque solution.

OBJECTIVES: This study aimed to investigate the efficacy of ionic and non-ionic-based contrast media (in vitro study) and the combinatorial effect of chitosan-based endo-radiopaque solution (CERS) (in vivo study) for visualization of the root canal anatomy. MATERIALS AND METHODS: In vitro study (120 teeth): The root canal of maxillary premolars and molars (in vitro group 1 and 2 respectively, n = 60 each) were analyzed using 4 different contrast media (subgroups: Omnipaque 350, Iopamidol, Xenetix 350, and Urografin 76; n = 15 each) in combination with 5.25% sodium hypochlorite (NaOCl). Based on the results of the in vitro study, in vivo study (80 teeth) was done to compare Xenetix 350 + 5.25% NaOCl with CERS (in vivo group 1 and 2 respectively, n = 40 each) on maxillary and mandibular premolars and molars. Two endodontists used radiovisiography to assess the depth of ingress and identify the aberrant root anatomy after access cavity preparation, and after initial cleaning and shaping of canals. Kruskal-Wallis test was used for in vitro comparison (p < 0.05), and Wilcoxon signed-rank test and Mann-Whitney U test for in vivo analysis (p < 0.01). RESULTS: In vitro study, Xenetix 350 + 5.25% NaOCl facilitated a significant higher visualization (p < 0.05). For in vivo study, CERS had a statistically significant depth of ingress (p < 0.01), and was efficient in identifying the aberrant root canal anatomy of premolars and molars. CONCLUSIONS: CERS facilitates better visualization of the root canal anatomy of human premolars and molars.

Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: interim results from a double-blind, randomised, multicentre, phase 2 trial, and 3-month follow-up of a double-blind, randomised phase 1 trial.

BACKGROUND: BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine (3 µg or 6 µg) formulated with a toll-like receptor 7/8 agonist molecule (IMDG) adsorbed to alum (Algel). We previously reported findings from a double-blind, multicentre, randomised, controlled phase 1 trial on the safety and immunogenicity of three different formulations of BBV152 (3 µg with Algel-IMDG, 6 µg with Algel-IMDG, or 6 µg with Algel) and one Algel-only control (no antigen), with the first dose administered on day 0 and the second dose on day 14. The 3 µg and 6 µg with Algel-IMDG formulations were selected for this phase 2 study. Herein, we report interim findings of the phase 2 trial on the immunogenicity and safety of BBV152, with the first dose administered on day 0 and the second dose on day 28. METHODS: We did a double-blind, randomised, multicentre, phase 2 clinical trial to evaluate the immunogenicity and safety of BBV152 in healthy adults and adolescents (aged 12-65 years) at nine hospitals in India. Participants with positive SARS-CoV-2 nucleic acid and serology tests were excluded. Participants were randomly assigned (1:1) to receive either 3 µg with Algel-IMDG or 6 µg with Algel-IMDG. Block randomisation was done by use of an interactive web response system. Participants, investigators, study coordinators, study-related personnel, and the sponsor were masked to treatment group allocation. Two intramuscular doses of vaccine were administered on day 0 and day 28. The primary outcome was SARS-CoV-2 wild-type neutralising antibody titres and seroconversion rates (defined as a post-vaccination titre that was at least four-fold higher than the baseline titre) at 4 weeks after the second dose (day 56), measured by use of the plaque-reduction neutralisation test (PRNT50) and the microneutralisation test (MNT50). The primary outcome was assessed in all participants who had received both doses of the vaccine. Cell-mediated responses were a secondary outcome and were assessed by T-helper-1 (Th1)/Th2 profiling at 2 weeks after the second dose (day 42). Safety was assessed in all participants who received at least one dose of the vaccine. In addition, we report immunogenicity results from a follow-up blood draw collected from phase 1 trial participants at 3 months after they received the second dose (day 104). This trial is registered at ClinicalTrials.gov, NCT04471519. FINDINGS: Between Sept 5 and 12, 2020, 921 participants were screened, of whom 380 were enrolled and randomly assigned to the 3 µg with Algel-IMDG group (n=190) or 6 µg with Algel-IMDG group (n=190). Geometric mean titres (GMTs; PRNT50) at day 56 were significantly higher in the 6 µg with Algel-IMDG group (197·0 [95% CI 155·6-249·4]) than the 3 µg with Algel-IMDG group (100·9 [74·1-137·4]; p=0·0041). Seroconversion based on PRNT50 at day 56 was reported in 171 (92·9% [95% CI 88·2-96·2] of 184 participants in the 3 µg with Algel-IMDG group and 174 (98·3% [95·1-99·6]) of 177 participants in the 6 µg with Algel-IMDG group. GMTs (MNT50) at day 56 were 92·5 (95% CI 77·7-110·2) in the 3 µg with Algel-IMDG group and 160·1 (135·8-188·8) in the 6 µg with Algel-IMDG group. Seroconversion based on MNT50 at day 56 was reported in 162 (88·0% [95% CI 82·4-92·3]) of 184 participants in the 3 µg with Algel-IMDG group and 171 (96·6% [92·8-98·8]) of 177 participants in the 6 µg with Algel-IMDG group. The 3 µg with Algel-IMDG and 6 µg with Algel-IMDG formulations elicited T-cell responses that were biased to a Th1 phenotype at day 42. No significant difference in the proportion of participants who had a solicited local or systemic adverse reaction in the 3 µg with Algel-IMDG group (38 [20·0%; 95% CI 14·7-26·5] of 190) and the 6 µg with Algel-IMDG group (40 [21·1%; 15·5-27·5] of 190) was observed on days 0-7 and days 28-35; no serious adverse events were reported in the study. From the phase 1 trial, 3-month post-second-dose GMTs (MNT50) were 39·9 (95% CI 32·0-49·9) in the 3µg with Algel-IMDG group, 69·5 (53·7-89·9) in the 6 µg with Algel-IMDG group, 53·3 (40·1-71·0) in the 6 µg with Algel group, and 20·7 (14·5-29·5) in the Algel alone group. INTERPRETATION: In the phase 1 trial, BBV152 induced high neutralising antibody responses that remained elevated in all participants at 3 months after the second vaccination. In the phase 2 trial, BBV152 showed better reactogenicity and safety outcomes, and enhanced humoral and cell-mediated immune responses compared with the phase 1 trial. The 6 µg with Algel-IMDG formulation has been selected for the phase 3 efficacy trial. FUNDING: Bharat Biotech International. TRANSLATION: For the Hindi translation of the abstract see Supplementary Materials section.

Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial.

BACKGROUND: To mitigate the effects of COVID-19, a vaccine is urgently needed. BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine formulated with a toll-like receptor 7/8 agonist molecule adsorbed to alum (Algel-IMDG) or alum (Algel). METHODS: We did a double-blind, multicentre, randomised, controlled phase 1 trial to assess the safety and immunogenicity of BBV152 at 11 hospitals across India. Healthy adults aged 18-55 years who were deemed healthy by the investigator were eligible. Individuals with positive SARS-CoV-2 nucleic acid and/or serology tests were excluded. Participants were randomly assigned to receive either one of three vaccine formulations (3 µg with Algel-IMDG, 6 µg with Algel-IMDG, or 6 µg with Algel) or an Algel only control vaccine group. Block randomisation was done with a web response platform. Participants and investigators were masked to treatment group allocation. Two intramuscular doses of vaccines were administered on day 0 (the day of randomisation) and day 14. Primary outcomes were solicited local and systemic reactogenicity events at 2 h and 7 days after vaccination and throughout the full study duration, including serious adverse events. Secondary outcome was seroconversion (at least four-fold increase from baseline) based on wild-type virus neutralisation. Cell-mediated responses were evaluated by intracellular staining and ELISpot. The trial is registered at ClinicalTrials.gov (NCT04471519). FINDINGS: Between July 13 and 30, 2020, 827 participants were screened, of whom 375 were enrolled. Among the enrolled participants, 100 each were randomly assigned to the three vaccine groups, and 75 were randomly assigned to the control group (Algel only). After both doses, solicited local and systemic adverse reactions were reported by 17 (17%; 95% CI 10·5-26·1) participants in the 3 µg with Algel-IMDG group, 21 (21%; 13·8-30·5) in the 6 µg with Algel-IMDG group, 14 (14%; 8·1-22·7) in the 6 µg with Algel group, and ten (10%; 6·9-23·6) in the Algel-only group. The most common solicited adverse events were injection site pain (17 [5%] of 375 participants), headache (13 [3%]), fatigue (11 [3%]), fever (nine [2%]), and nausea or vomiting (seven [2%]). All solicited adverse events were mild (43 [69%] of 62) or moderate (19 [31%]) and were more frequent after the first dose. One serious adverse event of viral pneumonitis was reported in the 6 µg with Algel group, unrelated to the vaccine. Seroconversion rates (%) were 87·9, 91·9, and 82·8 in the 3 µg with Algel-IMDG, 6 µg with Algel-IMDG, and 6 µg with Algel groups, respectively. CD4+ and CD8+ T-cell responses were detected in a subset of 16 participants from both Algel-IMDG groups. INTERPRETATION: BBV152 led to tolerable safety outcomes and enhanced immune responses. Both Algel-IMDG formulations were selected for phase 2 immunogenicity trials. Further efficacy trials are warranted. FUNDING: Bharat Biotech International.

Informed Consent for Emergency Obstetric Care During COVID-19 Pandemic.

Informed consent process has become a challenging issue before surgery for any emergency obstetric care during this COVID pandemic. There is an increased risk of morbidity if there is a need of intensive care unit postoperatively and a risk of high mortality if patient has symptoms of COVID-19. Admission to intensive care unit adds on to the financial burden to the patient. Also, there is an increased risk of perinatal anxiety and depression during the COVID pandemic. When an asymptomatic carrier develops symptoms of COVID after delivery or caesarean section, the morbidity increases. So we have designed an informed consent form for patients undergoing emergency obstetric surgeries incorporating some points specific for COVID-19.

Nanotechnology in Dentistry: Clinical Applications, Benefits, and Hazards.

Nanotechnology is emerging as an interdisciplinary field that is undergoing rapid development and has brought about enormous changes in medicine and dentistry. Nanomaterial-based design is able to mimic some of the mechanical and structural properties of native tissue and can promote biointegration. Nanotechnology has various applications in dentistry, including dentition renaturalization, therapy for dentin hypersensitivity, complete orthodontic realignment in a single visit, covalently bonding diamondized enamel, enhancing properties of root canal sealers, and continuous oral health maintenance using mechanical dentifrobots. A range of synthetic nanoparticles such as hydroxyapatite, bioglass, titanium, zirconia, and silver nanoparticles are proposed for dental restoration. This review focuses on the developments in the field of nanomaterials in dentistry in the form of tissue regeneration materials, implantable devices, nanocomposites, endodontic sealers etc. and issues of patient safety.

An In vitro Comparison of Pushout Bond Strength of Resilon with MetaSEAL and AH Plus Sealers.

AIM: The aim of this study is to evaluate and compare the pushout bond strengths of Resilon with two different sealers: Resilon/MetaSEAL (methacrylate based) and Resilon/AH Plus (an epoxy resin-based sealer). MATERIALS AND METHODS: Forty single canal anterior teeth were decoronated at cementoenamel junction and standardized to 10 ± 1 mm length. Working length was determined followed by biomechanical preparation. Then, the specimens were randomly assigned into two groups of 20 teeth each based on the sealer used with Resilon. All canals were obturated using single-cone obturation technique. Root samples were prepared for pushout testing. The universal testing machine gave the debonding force for individual specimen. This was done for all the specimens. STATISTICAL ANALYSIS: This was done by using unpaired Student's t-test. RESULTS: The roots filled with Resilon/MetaSEAL had higher bond strength (1.49 ± 0.09 MPa) compared to Resilon/AH Plus (0.90 ± 0.04 MPa) group. The difference in bond strength was statistically significant (P = 0.0000). CONCLUSION: Through this pushout bond strength test, it could be noted that MetaSEAL did appear to bond to the dentin and could be used as a potential endodontic sealer.

Bioactive Materials in Endodontics: An Evolving Component of Clinical Dentistry.

Achieving biocompatibility in a material requires an interdisciplinary approach that involves a sound knowledge of materials science, bioengineering, and biotechnology. The host microbial-material response is also critical. Endodontic treatment is a delicate procedure that must be planned and executed properly. Despite major advances in endodontic therapy in recent decades, clinicians are confronted with a complex root canal anatomy and a wide selection of endodontic filling materials that, in turn, may not be well tolerated by the periapical tissues and may evoke an immune reaction. This article discusses published reports of various bioactive materials that are used in endodontic therapy, including calcium hydroxide, mineral trioxide aggregate, a bioactive dentin substrate, calcium phosphate ceramics, and calcium phosphate cements.

Prescription patterns of hypolipidaemic drugs in a tertiary care teaching hospital of southern India.

OBJECTIVE: To evaluate the prescribing patterns of hypolipidaemic drugs which were prescribed to patients who visited the department of General Medicine in a tertiary care teaching hospital of southern India. MATERIALS AND METHODS: A cross-sectional study was done for three months in the department of General Medicine. A total of 506 prescriptions of hypolipidaemic drugs were evaluated, based on the various inclusion and exclusion criteria. The different disease patterns, the types of drugs which were prescribed in those diseases and the WHO prescription indicators, Anatomical Therapeutic Classification as well as the PDD (prescribing daily dose) /DDD (daily defined dose) ratio were calculated. RESULTS: While analyzing the prescriptions, it was found that patients having abnormal lipid profiles (56.9%) and normal lipid profiles (43.1%) were prescribed hypolipidaemic drugs. Diabetes with hypertension (37%) was the most common disease for which hypolipidaemic drugs were prescribed. The average number of drugs per prescription was 3.3±1.33. Atorvastatin was the most common hypolipidaemic drug which was prescribed as monotherapy (53.4%), whereas atorvastatin with aspirin was the most common drug which was prescribed as combination therapy (20%). Atorvastatin was prescribed as underdosed and Rosuvastatin was prescribed as overdosed. CONCLUSION: This study depicts the use of statins in various disease conditions, both as primary and secondary preventive measures. Such studies should be done to educate the physicians on good prescribing practices and on rational use of hypolipidaemic drugs.

Induction of Ovulation with Clomiphene Citrate Versus Clomiphene with Bromocriptine in PCOS Patients with Normal Prolactin: A Comparative Study.

INTRODUCTION: Polycystic ovarian syndrome (PCOS) is the main cause of anovulatory infertility. Various combination of drugs have been tried to induce ovulation in PCOS patients with varied result. So, this study was planned to compare the effect of bromocriptine combined with Clomiphene Citrate and Clomiphene Citrate alone, in patients of polycystic ovarian syndrome with normal prolactin level. MATERIALS & METHODS: On the basis of inclusion and exclusion criteria, seventy four PCOS patients with normal prolactin level (< 20 ng/ml) and BMI between 20-30 were randomly assigned into two groups. One group (n=38) received 50 mg clomiphene citrate (CC) from day3 to day7. The other group (CC+Bcrt) was given 50 mg of clomiphene citrate from day3 to day7 along with 0.8mg of bromocriptine daily for full cycle (n=36). Both the groups were treated for 3 cycles. The outcomes were measured by the hormonal status, follicular size, ovulation rate and pregnancy outcomes. RESULTS: The serum prolactin level was normal in both the groups before treatment. After 3 cycles the prolactin level decreased in (CC+Bcrt) group (p< 0.01). Follicular development (size >15mm) was observed in 30 patients (78.9%) in CC group and 28 patients (82.3%) in CC+Bcrt group. There was no significant change in hormonal status (LH, FSH and Estradiol) of both the groups. The rate of ovulation was 69.4% in CC group and 75.8% in CC+Bcrt group. During the treatment period, nine patients in CC group and seven patients in CC+Bcrt group became pregnant. CONCLUSION: There is no added benefit of bromocriptine with clomiphene citrate as compared to clomiphene alone in ovulation induction as well as pregnancy outcomes in PCOS patients with normal prolactin.