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Background: Good oral health during pregnancy can not only improve the health of the pregnant mother, but also potentially the health of her child. There is inconclusive and contrasting nature of evidence regarding the effect of pregnancy on oral health. So the purpose of this study was to systematically review the dental considerations during Pregnancy for further investigation. Methods: For the identification of the studies included in this review, we devised the search strategy for each database. The search strategy used a union of controlled vocabulary and free text terms. The main electronic database used to access the studies were PubMed, PubMed Central, Cochrane Review, Embase and Google Scholar. Results: A total of 28 articles fulfilled the criteria and were selected for the review. Some prenatal oral health conditions have adverse effects on the child. Periodontitis is associated with preterm birth, low birth weight infants and high level of cariogenic bacteria in pregnant mother can lead to increased risk of dental caries in the infant. Oral lesions such as gingivitis and pregnancy tumours are benign in nature and require only reassurance and monitoring. Conclusion: It has been suggested that some oral conditions may have adverse consequences on their children awareness related to oral health during pregnancy. Oral health care services should be routinely integrated with prenatal care services for all the pregnant women and specific preventive oral health care program should be made an integral part of antenatal care.

Objective: To review and study the oral health status among visually and hearing-impaired individuals. Data Sources and extraction: A literature was performed in main databases like- Pub Med Central, Cochrane Library, Embase and Google Scholar from year 2001 to 2020. This systematic review study was done according to PRISMA guideline. Data synthesis: It was found that disabled individuals had poor oral health status as compared to the non-disabled individuals. Blind children experienced more caries than hearing-impaired children in permanent, whereas it was opposite in primary dentition. Braille language and text instructions can be very useful for visually impaired individuals irrespective of the degree of blindness and can help them to maintain oral hygiene. Hearing impaired individuals are taught with actions and visualisations. Conclusion: As a public health personnel, the fact, it is extremely difficult to change people's attitudes rapidly. The sighted must know how to deal with the blind individuals and learn to overcome their own ambiguity, or their undesirable attitudes may be implemented and talk of social acceptance should not be felt in mind. Keywords: Oral health status, Disability, Oral health related quality of life, Hearing impaired, Visually impaired

BACKGROUND Second Hand smoke (SHS) exposure to children causes several systemic problems like asthma, dental problems like caries and effects overall well being. This study was conducted to study impact of SHS on primary school children by associating it with dental caries, cotinine level, asthma severity and overall well being. METHODS Case control study was conducted amongst 200 children 9-15 years old that came to dental college in Muradnagar. Children who lived in smoking households were identified as SHS subjects-100 children and those who lived in non smoking households were identified as control group- 100 children. Parents completed questionnaire regarding their smoking status. In children's questionnaire severity of asthma was determined by using expert panel report (EPR3), dental caries was recorded by dmft index and psychological assessment of children was done using WHO- 5 well being index. Collection of unstimulated saliva of children was done in sterile plastic tubes and cotinine level was measured using enzyme-linked-immunosorbent assay (ELISA). Students t test and one way analysis of variance (ANOVA) was used for analysing data. RESULTS Mean number of children suffering from asthma was higher in SHS subjects in comparison to control group i.e. 348.9 ±166.509 and 247.3±15.86 respectively. dmft and WHO- well being scores increased as level of cotinine increased. Mean cotinine level was higher in SHS subjects than control group i.e. 348.9 ±166.509 and 247.3±15.86 respectively. CONCLUSIONS SHS has an adverse impact on young children reflected by poor dmft scores and psychological well being, increased cotinine levels and asthma severity in comparison to control group.

Background The American Council of Graduate Medical Education (ACGME) guidelines for scholarly activities by family medicine residents require at least one activity per resident and encourage conference presentations. Meeting these guidelines has traditionally been challenging due to a multitude of factors from lack of time to limited administrative support. Studies have shown that resident participation in research was associated with higher levels of satisfaction with training. We aimed to develop and evaluate the effectiveness of a dedicated research curriculum in achieving ACGME goals for our residents. Methods We performed a need assessment that identified strengths and obstacles related to research which then guided the actions taken to build the curriculum. Revised curricular elements included a research focused lecture series, a restructured journal club, financial support for presentations and project expenses, a specific timeline for project completion, and the development of a regional research day involving multiple family medicine programs. Dedicated research time was built into the resident schedule and presentations at local, regional and national conferences were encouraged and supported. Results Following implementation of the curriculum there was a marked increase in the number of scholarly projects performed by residents. Prior to implementation there had only been one presentation at a national conference in the previous five years. This increased to an average of four presentations per year in the following five year period. On a regional scale, the initial success of the local research day led to a continued expansion and now includes six family medicine programs. Conclusion Implementation of a dedicated multifaceted research curriculum significantly increased the participation of our residents in scholarly activities and led to a near five-fold increase in presentations at regional and national levels. Additionally, resident satisfaction in scholarly activities increased and a far greater number of graduating residents went on to complete fellowships.

Multiple analytical and preclinical studies were performed to compare the biochemical characteristics, pharmacokinetics (PK), safety and neoantigenicity of a new 5% liquid formulation of Alpha-1 Proteinase Inhibitor (Liquid A1PI, Prolastin®-C Liquid) with the lyophilized version (Lyophilized A1PI, Prolastin®-C). Liquid A1PI and Lyophilized A1PI had similar average mass (~52 kDa), and both forms exhibited glycoform patterns consistent with the known banding pattern of A1PI (dominated by the M6 and M4 bands, including deconvoluted masses). Both Liquid A1PI and Lyophilized A1PI yielded average percent purity values ranging from 96% to 99% and had active content ranging from 53 mg/mL to 59 mg/mL. The PK profile of Liquid A1PI was similar to Lyophilized A1PI. Safety assessments in rabbits showed good tolerability and no test article-related changes in mortality, clinical signs, clinical pathology, body weight, food consumption, or urinalysis parameters. Following immunodepletion of antibodies that recognize Lyophilized A1PI, there were no significant differences in the anti-drug titers among animals immunized with Lyophilized A1PI and Liquid A1PI (p > 0.05), indicating that no antibodies to neoantigens were generated. Liquid A1PI and Lyophilized A1PI have similar profiles with respect to biochemical characteristics, PK, safety and neoantigenicity.

BACKGROUND: Oral diseases place a huge economic and social burden on the population in terms of pain, suffering and lost productivity, as well as expenditure on treatment and prevention. The elderly people are worst affected by tooth loss as edentulism further leads to deterioration of their existing frail general health. MATERIALS AND METHOD: The present study is an attempt to study the prosthodontic status of people attending a private clinic in Delhi from April to December 2018. Data was collected with the help of WHO Oral Health Assessment Form (2004) and survey was conducted as per guidelines of American Dental Association for Type III examination. Statistical analysis was done using SPSS 20.0. RESULTS: Out of 204 study subjects, 30.4% were completely dentulous, 7.4% were completely edentulous and rest were partially edentulous for the maxillary arch. While 34.8% were completely dentulous, 14.7% were completely edentulous and 50.5% were partially edentulous for the mandibular arch. Prosthodontic status for both the maxillary and mandibular arch was very poor with 79.4% and 85.3% individuals being devoid of any kind of prosthesis in the maxillary and mandibular arch respectively. CONCLUSION: The population of Delhi has a poor prosthodontics status. High cost of prosthetic treatment, lack of availability of skilled healthcare professionals, poor infrastructure and the general attitude of the population towards replacement of missing teeth are the major hindrances in the way of healthcare delivery system in our country. This has lead to the poor prosthodontic status in general population.

INTRODUCTION: Anxiety is a common problem frequently experienced by patients undergoing dental procedures in every dental setting. The present study aimed to assess the prevalence of dental anxiety among the patients visiting the Out Patient Department (OPD) of a Dental Institution in Panchkula, Haryana.MATERIALS & METHOD: A sample of 600 adults (Females =298, Males = 302) with age ranging from 21 years to 65 years were enrolled in the study. The Modified Dental Anxiety Scale was used to measure dental anxiety among the study population. Chi Square test and ANOVA was used to find significant comparisons between the different variables assessed in the study. Further, Spearman’s Correlation was used to analyse these variables with the mean anxiety scores of the patients.RESULTS: The prevalence of anxiety among patients was found to be high. Reportedly the level of anxiety was found more in females than in males. It was revealed that with advancing age and higher education level, there was a decrease in level of anxiety, postponement of the dental treatment had a direct effect on dental anxiety. Previous unfavourable dental experience has a high impact on dental anxiety scores.CONCLUSION: Evaluation of anxiety levels in the subjects of this study suggests that majority of them are anxious towards dental treatment. Dental anxiety is one of the major barrier in the utilization of dental services. There is a strict need of directing efforts towards alleviation of this hindrance to provide a good quality dental care to the needy population.

Background Due to high prevalence of oral diseases extraction of primary teeth is a common and a major concern in developing countries. These teeth are given least importance as they are believed to shed off automatically, thus leading to serious problems like crowding and malocclusion. Material and methods A cross sectional study was carried out among children aged 5 to 12 years among 1347 children. The data was recorded on a prestructured questionnaire. Reasons for extraction of teeth were based on Kay and Blinkhorn criteria. Results 20.4% children were having tooth loss due to various reasons. The main reason for extraction was found to be caries in 64.3% followed by trauma in maxillary teeth among 43.02% of children. Conclusions Presence of early loss of primary teeth result in occlusal disturbances and space loss among children. Hence, proper treatment regimens must be followed by the dental professionals and should be the need of the hour. Key words:Extraction, children, primary teeth, caries.

Background and Aims: Despite tremendous considerable effort by health professionals to promote oral health to create beautiful smiles, gap between oral health knowledge and practice undoubtedly still remains. Thus the aim of this study was to assess the Oral health literacy level and its impact on socioeconomic and oral health status among adult population in Ghaziabad district. Methods: A total of 600 study subjects aged 18-64 years from all 4 blocks of Ghaziabad visiting various outreach programmes using a multistage random sampling technique were included in the study. A specially designed questionnaire assessed the demographic variables. Oral health literacy level (OHL) was assessed with help of a bilingually adapted Hindi OHL tool. Clinical examination was recorded using WHO (World Health Organization) Oral Health Assessment Form 2013. Results: The mean age of the study subjects was 43.9 ± 14.36 years. Majority 300 (50%) study subjects had inadequate oral health literacy level followed by Marginal oral health literacy level which was seen among 180 (30%) subjects and 120 (20%) subjects had adequate oral health literacy level. Oral health literacy level was slightly higher among females as compared to male subjects although the results were not statistically significant. A statistically significant difference was found between oral health literacy and oral health status as well as socioeconomic status. (P value ≤ 0.05). Conclusion: A significant association between OHL and oral health status was found stating Oral health literacy as an efficient role in influencing oral health outcome of any individual.

The aim of this study was to find out the prevalence of oro-dental anomalies among 14 to 17 years students in Panchkula District Haryana, India. Oral examination among 3248 students (1608 males and 1640 females) aged 14 to 17 years in Panchkula District of Haryana was carried out in 18 secondary and intermediate schools. Oro-dental developmental anomalies seen in 946 students represents 29.1% of the studied sample, 42.1% males and 57.9% females; there was a significant statistical difference between them. Majority of the oro-dental developmental anomalies were presented in 16 years age group in the sample. The study reported that 29.8% of the participants were affected with atleast one dental anomaly. Enamel hypoplasia, followed by microdontia was the most common findings. Geographic tongue, commissural lip pits, fissured tongue and lingual varicosities showed a significant statistical difference among the two genders. Key words: Oral anomalies, dental anomalies, prevalence.

Objectives: The aim of the study was to compare the effect of fifth and seventh generation bonding agent on sealant success. Materials and Methods: Sixty-four school children aged six to nine years received sealants in four permanent molars in a split mouth design, such that each patient received sealant in the first permanent molar with fifth generation bonding agent in one arch and seventh generation bonding agent in the other arch; contra-lateral molars were sealed with sealant alone. The evaluation was carried out at baseline, three months, six months and 12 months, according to the criteria by Feigal et al, in 2000. Chi- square test was used to analyze data at P

Clustering is among the data mining techniques to group the data into subsets to retrieve useful information from the data set. Clustering involves selecting the k-cluster centres randomly and grouping that data around those centres. Genetic algorithms are heuristic algorithms that have been applied to clustering problem for optimization. Genetic algorithms follow the process of natural selection and work in iterative manner, generating new population from the old one. The initial population is randomly initialized. The whole iterative process is influenced by the initial values selected at start. So, the proper selection also affect optimization problem. In this paper, we have proposed a firefly based genetic algorithm (FAG) where the initial population is selected from a pool of population on the basis of fire-fly algorithms. Fire-fly algorithms are also biologically inspired algorithm and are used to optimization problem. FAG algorithm is then applied to the publically available datasets from UCI repository. The results obtained are very much satisfactory and competitive as compare to the basic genetic and firefly algorithm.

Health Literacy is the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate decisions. As with general health; achieving and maintaining oral health requires one to be able to understand, interpret and act on various types of health information.The present study was conducted to determine the association between health literacy and oral health literacy among undergraduate students in tricity (Chandigarh, Mohali, Panchkula), India.A cross-sectional study was conducted among 490 undergraduate students studying in tricity, from randomly selected 10 colleges. The data was collected by a single trained examiner, using a structured proforma. The questionnaire consisted of two parts, REALM-66 and REALD-30. The subject was given a copy of list of words to be pronounced and score one was given for each word pronounced correctly.REALM-66 scores showed that subjects with health literacy level equivalent to fourth- sixth grade is 1%, seventh- eighth grade was 64.4% and 29.6% for ninth grade and above. REALD-30 scores showed that 37.6% subjects had low level of literacy, 33.1% had moderate and 29.3% had high level of literacy. REALM and REALD scores were found to be positively correlated for qualification and genders.To our knowledge, this is the first study reporting association between health and oral health literacy. As the correlations were not strong, thus the results should be regarded as a first step to provide evidence.

Free radicals play a key role in the development of several pathological conditions. Therefore, antioxidants (AOs) are the first line of defense against free radical damage and are critical for maintaining optimum health and well-being.To assess the perception of dental practitioners regarding use of antioxidants in oral health.A cross-sectional questionnaire study was conducted among 296 dental practitioners in Tricity (Chandigarh, Mohali, Panchkula, India). A self-structured close-ended questionnaire was used to assess the perception of dentists regarding the use of antioxidants in their patients. It consisted of 12 questions with dichotomous response and five point likert scale ranging from strongly agree to strongly disagree. Descriptive statistics were used to summarize the data, followed by the Chi-square test to check significant differences between the responses. Correlation between responses were analysed through the Spearman's rank correlation. Statistical analysis was done using Statistical Package for Social Sciences version 20 (Illinois, Chicago, USA).A statistically significant difference was observed between genders, with females 181 (61%) having more knowledge than males 115 (39%) regarding the use of antioxidants in their clinical practice. It has been found that dental professionals in academics prescribes more antioxidants to their patients than the private practitioners. Postgraduates 76 (77.6%) had a higher level of knowledge than graduates 86 (43%).Knowledge about antioxidants should be highlighted in the health sciences curriculum. It is recommended to expand the use of antioxidants in oral health to bring down the burden of chronic diseases like periodontitis and catastrophic diseases like precancerous lesions and oral cancer.antioxidants, free radicals, mouth neoplasms, oral health.

Tobacco use is the foremost preventable cause of death and disease in the world today and work strain might be related with nicotine dependence by its provoking effect.To assess the association between occupational stress and nicotine dependence.A cross sectional survey was conducted among 200 subjects visiting a satellite dental clinic of Swami Devi Dyal Hospital and Dental College, Barwala, Panchkula, India. Nicotine dependence was measured using the Fagerstrom Test for Nicotine Dependence (FTND). The extent of the stress factors experienced at work was assessed using the Effort-Reward Imbalance scale (ERI). Chi-square test and multiple logistic regression analysis were employed for statistical analysis. Confidence level and level of significance were set at 95% and 5% respectively.The results of bivariate analysis revealed association of occupational stress with age, marital status, educational status, level of nicotine dependence, frequency of cigarette smoking and religious attendance. However, multivariate analysis elicited the significant association of occupational stress with only two variables, level of nicotine dependence and frequency of smoking.Occupational stress was found to be associated with nicotine dependence in the present study implying a need of other tranquil measures to be incorporated for the relief of work related stress.

Introduction: The world of fashion is ever changing and this dynamics applies to dentistry. As dentistry and dental treatments have become necessary facet of a healthy life and therefore down the line fashion prospect of tooth jewellery are also getting fused into it. Aim: To assess the knowledge and practice of tooth jewellery among practicing dentists of Tricity, India. Materials and Methods: A descriptive, cross-sectional study was conducted among 310 dental practitioners in Tricity (Chandigarh, Mohali and Panchkula), India. A self-administered, close-ended questionnaire was distributed among all the dental practitioners in order to assess their knowledge and practice regarding tooth jewellery. Responses of the questionnaire was obtained on the dichotomous scale with Yes and No. Right answers were given a score of 2 whereas the wrong answers were given as score of 1. The data was analyzed using unpaired students t-test, one way ANOVA (analysis of variance) and multivariate logistic regression. Results: A significant difference was observed among the genders with males being three times more knowledgeable (OR=3.5, 95%CI: 0.8-2.8). It has been found that knowledge and practice scores of dental practitioners who spend more than 10 hours per day have two times more knowledge (OR= 2.3, 95%CI:0.08-1.1) than others. The dentists holding the masters degree were having three times more knowledge than the graduates’ ones (OR= 2.3, 95%C.I:0.1-1.9). Conclusion: The present study concluded that dental practitioners had sufficient knowledge about tooth jewellery. Practice of tooth jewellery in the dental clinics was found to be adequate but it was also associated with some complications. To overcome this, it is advised that professional and government bodies should create strategies for enhancing and improving people’s knowledge as well as make them aware of the pros and cons while using tooth jewellery which shall further enhance their smile.

Context: Plasma fibrinogen degradation products (FDPs) and oral submucous fibrosis (OSMF). Background: OSMF is a chronic, progressive, scarring disease of multifactorial etiology. Areca nut is found to be the main cause of this disease. But it has been found in the routine clinical practice that some individuals with the habit of areca nut chewing may not show any clinical evidence of OSMF, while some individuals without the habit of areca nut chewing are found to have OSMF. So, there must be some other factors associated with OSMF. Recently, plasma FDPs have been identified as an early indicator of disease in OSMF patients. A systematic review of their role would help to elucidate whether there is an association of these FDPs in the pathogenesis of OSMF or not. Objective: To review studies reported in the literature elucidating the role of these plasma FDPs in OSMF. Materials and Methods: Articles were searched in PubMed; MEDLINE using appropriate key words like “plasma fibrinogen degradation products” and “oral submucous fibrosis.” Hand search of journals was also performed. Articles were reviewed and analyzed. Results: The search strategy revealed nine relevant articles which studied the role of these plasma FDPs in the etiopathogenesis of OSMF and further progression of this disease with the increased clinical grades and the risk of carcinoma, but the exact role of these factors is still obscure. Conclusion: The data validate the role of plasma FDPs in the etiopathogenesis of OSMF. Studies with a large sample size are still required to evaluate the definite association between these FDPs and OSMF. It has the advantage of being a noninvasive method to evaluate the stage of OSMF patients, instead of using the invasive techniques like biopsy.

Antisense technology constitutes development of sequence-specific DNA or RNA analogs that can block the activity of selected single-stranded genetic sequences and offer the potential of high specificity lacking in many current drug treatments. The sequencing of the human genome has greatly increased the potential of this approach. Antisense oligonucleotides, the most commonly used antisense approach, are unmodified or chemically modified single stranded RNA or DNA molecules specifically designed to hybridize to corresponding RNA by Watson-Crick binding. Phosphorodiamidate Morpholino oligomers (PMO) are a novel class of non-ionic antisense agents that inhibit gene expression by binding to RNA and sterically blocking processing or translation. PMOs have shown excellent efficiency and safety profile via various routes of administration in multiple animal and human studies. This review will summarize the preclinical studies with PMOs on the road to their development as therapeutic agents with particular emphasis on in vivo biodistribution and pharmacokinetics.

Antisense phosphorodiamidate morpholino oligomers (PMO) inhibit targeted gene expression by preventing ribosomal assembly, thus preventing translation. Inhibition of cytochrome P450 (P450) 3A4 expression was examined in primary human hepatocytes from 11 donors and in Caco-2 cells (stably transfected with CYP3A4 cDNA on an extrachromosomal vector) by evaluating the metabolism of substrate 7-benzyloxy-4-[trifluoromethyl]-coumarin and Western immunoblot analysis. Cellular uptake of PMO was confirmed in both cell systems using fluorescein-labeled PMOs. Three antisense PMO sequences and two control PMO sequences were tested. AVI-4557, a 20-mer PMO with the sequence 5'-CTGGGATGAGAGCCATCACT-3' was selected as the optimal agent. AVI-4557 inhibited expression of CYP3A4 in Caco-2/h3A4 cells by 64% at 24 h following administration of 2.8 microM by an assisted delivery protocol. Inhibition of CYP3A activity was observed in primary human hepatocytes after 24 h exposure to AVI-4557 by an average of 32 +/- 11%. Furthermore, AVI-4557 exposure resulted in a sequence-dependent inhibition of cyclophosphamide-related cytocidal activity and a sequence-dependent induction of paclitaxel-related cytocidal activity in both cell types. Finally, the cytocidal activity of cisplatin was not affected with AVI-4557 treatment in either cell type. These studies indicate AVI-4557 is an effective and specific inhibitor of CYP3A4 expression.

Purpose. To determine if dermal absorption of an antisense phosphorodiamidate Morpholino oligomers (PMO) can inhibit target gene expression in the liver in vivo.

Purpose. This study characterizes the in vivoproperties of an in situforming gel, comprising an IPC of water-soluble polymers, PMA and PEG, for sustained release of macromolecular drugs. Methods. 40, 50 or 60% w/v formulations were injected subcutaneously in a rat model either alone, or containing model macromolecules, 3A2-ATG-psODN or REV-psODN, to (i) determine the approximate gelling and residence time of the gel at the site of injection, (ii) assess the biological efficacy of the formulation using a MZ sleep time model, and (iii) demonstrate specificity of the sequence and selectivity of the psODNs by measuring changes in microsomal enzyme levels and urine volumes. Results. A sol to gel transition requires 15 min in vivo, and the 60% w/v IPC gel remains at the site of injection for up to 72 hr. The MZ sleep times and CYP3A2 expression due to 3A2-ATG-psODNs released from the gel are significantly different compared to that of REV-psODNs. Conclusions. The IPC solutions exhibit phase transformation in vivo, and demonstrate no evidence of toxicity. The pharmacological effects observed from the of release of 3A2-ATG-psODNs suggest that the formulation can entrap, protect, and sustain the delivery of macromolecules.

Products from human blood were among the earliest biologics developed as drugs for human therapy. Since the approval of the first recombinant factor VIII (rFVIII) in 1992, they also include recombinant biotechnologies-derived products, as well as blood and plasma for transfusion and biotherapeutics purified from human blood (e.g. immunoglobulins, coagulation factors, hyperimmune products, or antitoxins). During the last 25 years new generations of plasma-derived and recombinant coagulation factors and other recombinant hemostatic agents have addressed the need for more pure proteins and improved therapies. The nature and composition of the nonclinical drug development plan can vary greatly for biologics in general, and blood products are no exception. A key difference between plasma protein-derived therapies and other biologics is that multiple interdependent products are manufactured from a single starting material. The complex and multifaceted nature, as well as the human origin of this starting material, makes the need for emphasis on pathogen safety and viral inactivation a key focus for both the industry and regulatory agencies. Recombinant blood proteins may follow nonclinical development plans comparable to other recombinant proteins based in ICH S6(R1) and ICH S3(R2).

BackgroundTissue type plasminogen activator is the only approved thrombolytic agent for the treatment of ischemic stroke. However, it carries the disadvantage of a 10-fold increase in symptomatic and asymptomatic intracranial hemorrhage. A safer thrombolytic agent may improve patient prognosis and increase patient participation in thrombolytic treatment. A novel direct-acting thrombolytic agent, Δ(K2-K5) plasmin, promising an improved safety profile was examined for safety in the snare ligature model of stroke in the rat.MethodsMale spontaneously hypertensive rats were subjected to 6 hours middle cerebral artery occlusion followed by 18 hours reflow. Beginning 1 minute before reflow, they were dosed with saline, vehicle, Δ(K2-K5) plasmin (0.15, 0.5, 1.5, and 5 mg/kg) or recombinant tissue-type plasminogen activator (10 and 30 mg/kg) by local intra-arterial infusion lasting 10 to 60 minutes. The rats were assessed for bleeding score, infarct volume, modified Bederson score and general behavioral score. In a parallel study, temporal progression of infarct volume was determined. In an in vitro study, whole blood clots from humans, canines and rats were exposed to Δ(K2-K5). Clot lysis was monitored by absorbance at 280 nm.ResultsThe main focus of this study was intracranial hemorrhage safety. Δ(K2-K5) plasmin treatment at the highest dose caused no more intracranial hemorrhage than the lowest dose of recombinant tissue type plasminogen activator, but showed at least a 5-fold superior safety margin. Secondary results include: temporal infarct volume progression shows that the greatest expansion of infarct volume occurs within 2–3 hours of middle cerebral artery occlusion in the spontaneously hypertensive rat. A spike in infarct volume was observed at 6 hours ischemia with reflow. Δ(K2-K5) plasmin tended to reduce infarct volume and improve behavior compared to controls. In vitro data suggests that Δ(K2-K5) plasmin is equally effective at lysing clots from humans, canines and rats.ConclusionsThe superior intracranial hemorrhage safety profile of the direct-acting thrombolytic Δ(K2-K5) plasmin compared with recombinant tissue type plasminogen activator makes this agent a good candidate for clinical evaluation in the treatment of acute ischemic stroke.