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Introduction: The provision of dental services to children with special health care needs historically has been given limited attention by the dental profession. Under - diagnosis and differential oral health treatment contribute to the poor oral health of adults with disabilities. The present study was undertaken to assess the oral health status and behaviour among differently abled children. Methodology: The study sample comprised of 317 subjects who were disabled and attending special schools. All the teeth were examined for dental caries. Mouth mirrors and CPI probes were used according to the WHO criteria. Clinical assessment of the oral health status was done by using the simplified oral hygiene index, DMFT. Chi square test and ANOVA were used to compare categorical variables. Results: The study consists of 317 intellectually disabled (ID) children, divided into three groups, out of which 65 (20.50%), 184 (58.04%) and 68 (21.45%) were suffering from autism, cerebral palsy and mental retardation respectively. Irrespective of the type of disability, most of the subjects consulted dentist only in need. The decayed teeth in subjects with mental retardation, cerebral palsy and autism were 2.37±1.01, 1.91±1.50 and 1.75±1.11 respectively and 58.82% of the mentally retarded subjects reported with poor oral hygiene status. Conclusion: In comparison with normal children, the disabled subjects were not given enough dental care with respect to their treatment needs. Taking into consideration the multi factorial influence on oral health status of the present disabled population, oral health promotion and intervention programs should be targeted and concentrated towards these risk groups.

Currently, several biosimilars of low‐molecular‐weight heparins (LMWHs) with differing potencies are being developed and marketed globally. Thus, it is important that the potency of each biosimilar LMWH be compared with its innovator's molecule. The present study aimed to determine the bioequivalence of biosimilar (Cloti‐Xa™) and innovator (Clexane®) formulations of enoxaparin sodium (40 mg/0.4 ml) in healthy human volunteers. It was conducted as a single‐dose, randomized, double‐blind, two‐period, two‐treatment, two‐sequence, crossover, balanced, pharmacodynamic study (NCT05265676). The participants were sequentially and randomly administered subcutaneous injections of Cloti‐Xa™ (test) and Clexane® (reference), separated by a one‐week washout period. To assess the Anti‐Xa & Anti‐IIa activities, tissue factor pathway inhibitor (TFPI) release and activated partial thromboplastin time (aPTT), blood samples were obtained at various timepoints upto 24 h after the drug administration. Bioequivalence was concluded if the two‐sided 90% CI for the test to reference ratio of the population is within 80%–125% for each of the Ln‐transformed values of Amax and AUECt for Anti‐Xa and Anti‐IIa. TFPI and aPTT data were submitted as supportive evidence. The study sample consisted of twenty‐four male participants. The 90% CIs of Amax and AUECt for Anti‐Xa activity were 105.50%–113.90% and 103.97%–112.08%, and for Anti‐IIa activity were 106.56%–117.90% and 107.35%–124.86%, respectively. In addition, the 90% CI of the ratio of Anti‐Xa/Anti‐IIa activity falls within the acceptance criteria. TFPI and aPTT profiles were similar for both products. No serious adverse events were observed during the study. Conclusively, the results showed that Cloti‐Xa™ and Clexane® are bioequivalent and well‐tolerated. [ABSTRACT FROM AUTHOR]

This study aimed to assess the nephrotoxicity associated with VRP-034 (novel formulation of polymyxin B [PMB]) compared to marketed PMB in a three-dimensional (3D) kidney-on-a-chip model. To model the human kidney proximal tubule for analysis, tubular structures were established using 23 triple-channel chips seeded with RPTEC/hTERT1 cells. These cells were exposed to VRP-034 or PMB at seven concentrations (1-200 µM) over 12, 24, and 48 h. A suite of novel kidney injury biomarkers, cell health, and inflammatory markers were quantitatively assessed in the effluent. Additionally, caspase and cytochrome C levels were measured, and cell viability was evaluated using calcein AM and ethidium homodimer-1 (EthD-1). Exposure to marketed PMB resulted in significantly elevated levels ( P < 0.05) of four key biomarkers (KIM-1, cystatin C, clusterin, and OPN) compared to VRP-034, particularly at clinically relevant concentrations of ≥10 µM. At 25 µM, all biomarkers demonstrated a significant increase ( P < 0.05) with marketed PMB exposure compared to VRP-034. Inflammatory markers (interleukin-6 and interleukin-8) increased significantly ( P < 0.05) with marketed PMB at concentrations of ≥5 µM, relative to VRP-034. VRP-034 displayed superior cell health outcomes, exhibiting lower lactate dehydrogenase release, while ATP levels remained comparable. Morphological analysis revealed that marketed PMB induced more severe damage, disrupting tubular integrity. Both treatments activated cytochrome C, caspase-3, caspase-8, caspase-9, and caspase-12 in a concentration-dependent manner; however, caspase activation was significantly reduced ( P < 0.05) with VRP-034. This study demonstrates that VRP-034 significantly reduces nephrotoxicity compared to marketed PMB within a 3D microphysiological system, suggesting its potential to enable the use of full therapeutic doses of PMB with an improved safety profile, addressing the need for less nephrotoxic polymyxin antibiotics., Competing Interests: The authors of this study are employees of Venus Medicine Research Centre, which is the developer of the drug being investigated. This study was funded by Venus Medicine Research Centre. The authors declare no additional competing interests.