Evaluating newly approved drugs in combination regimens for multidrug-resistant tuberculosis with fluoroquinolone resistance (endTB-Q): study protocol for a multi-country randomized controlled trial.

BACKGROUND: Treatment for fluoroquinolone-resistant multidrug-resistant/rifampicin-resistant tuberculosis (pre-XDR TB) often lasts longer than treatment for less resistant strains, yields worse efficacy results, and causes substantial toxicity. The newer anti-tuberculosis drugs, bedaquiline and delamanid, and repurposed drugs clofazimine and linezolid, show great promise for combination in shorter, less-toxic, and effective regimens. To date, there has been no randomized, internally and concurrently controlled trial of a shorter, all-oral regimen comprising these newer and repurposed drugs sufficiently powered to produce results for pre-XDR TB patients. METHODS: endTB-Q is a phase III, multi-country, randomized, controlled, parallel, open-label clinical trial evaluating the efficacy and safety of a treatment strategy for patients with pre-XDR TB. Study participants are randomized 2:1 to experimental or control arms, respectively. The experimental arm contains bedaquiline, linezolid, clofazimine, and delamanid. The control comprises the contemporaneous WHO standard of care for pre-XDR TB. Experimental arm duration is determined by a composite of smear microscopy and chest radiographic imaging at baseline and re-evaluated at 6 months using sputum culture results: participants with less extensive disease receive 6 months and participants with more extensive disease receive 9 months of treatment. Randomization is stratified by country and by participant extent-of-TB-disease phenotype defined according to screening/baseline characteristics. Study participation lasts up to 104 weeks post randomization. The primary objective is to assess whether the efficacy of experimental regimens at 73 weeks is non-inferior to that of the control. A sample size of 324 participants across 2 arms affords at least 80% power to show the non-inferiority, with a one-sided alpha of 0.025 and a non-inferiority margin of 12%, against the control in both modified intention-to-treat and per-protocol populations. DISCUSSION: This internally controlled study of shortened treatment for pre-XDR TB will provide urgently needed data and evidence for clinical and policy decision-making around the treatment of pre-XDR TB with a four-drug, all-oral, shortened regimen. TRIAL REGISTRATION: ClinicalTrials.Gov NCT03896685. Registered on 1 April 2018; the record was last updated for study protocol version 4.3 on 17 March 2023.

La linfogammagrafía in vivo de los tumores del seno nasal identifica el ganglio retrofaríngeo y el nivel I como ganglios centinela predominantes / In-vivo lymphoscintigraphy of sinonasal tumors identifies retropharyngeal node and level I as predominant sentinel nodes

Objetivo Evaluar mediante linfogammagrafía in vivo y con detección SPECT/TC los patrones de drenaje linfático de los tumores del seno paranasal (SPN). Confirmar o rebatir la creencia de que el ganglio linfático retrofaríngeo (GLRF) se erige en el ganglio de drenaje índice para dichos tumores. Métodos Estudio de cohorte prospectivo realizado en pacientes con tumores del SPN no tratados previamente y sin evidencia clínico-radiológica de metástasis a nivel ganglionar. La linfogammagrafía se realizó mediante la inyección peritumoral de sulfuro coloidal marcado con [99m]TcO4 y asistida por endoscopia nasal. Las inyecciones se clasificaron como anteriores o posteriores en función de una línea vertical que pasaba por el orificio del seno maxilar. Resultados Se incluyeron 17 pacientes. La linfogammagrafía identificó satisfactoriamente 17 ganglios centinelas en 15 pacientes, y no pudo evidenciarlo (fracaso de la linfogammagrafía) en 2 pacientes. Se observó que los lugares predominantes de drenaje del ganglio centinela fueron el GLRF (n=8; 47%) y el nivel I (n=7; 42%). Se identificó drenaje ocasional en el ganglio periparotídeo (n=1) y en el nivel II (n=1). Se observó drenaje linfático contralateral en 2 pacientes (en el nivel I y GLRF, respectivamente). Las inyecciones anteriores drenaron predominantemente hacia el nivel I (6/8) y a GLRF (2/8), mientras que las inyecciones posteriores drenaron predominantemente a GLRF (6/7). El riesgo relativo de que el GLRF fuera identificado como ganglio centinela fue significativamente mayor en las inyecciones administradas posteriormente respecto a las administradas anteriormente (RR: 3,43; IC 95%: 1,0-11,8; p=0,05). Conclusión El GLRF es considerado un ganglio de drenaje frecuente asociado a los tumores del seno nasal, y merece su atención rutinaria en todos los casos de tumor del seno nasal (AU)

Objective To evaluate by in vivo lymphoscintigraphy and SPECT-CT imaging, the lymphatic drainage patterns of para-nasal sinus (PNS) tumours. To confirm or refute the belief of the retropharyngeal lymph node (RPLN) being the significant draining lymph node for such tumours. Methods Prospective cohort study conducted on previously untreated PNS tumours with no clinico-radiological evidence of lymph node metastasis. Lymphoscintigraphy undertaken by nasal endoscopic assisted peritumoral injection of 99mTc sulphur colloid. Injections were classified as anterior or posterior as per a vertical line along the maxillary sinus ostium. Results Seventeen patients were included. Lymphoscintigraphy successfully identified 17 sentinel nodes in 15 patients and was unsuccessful (lymphoscintigraphy failure) in 2 patients. Predominant sites of sentinel lymphatic drainage were noted to be the RPLN (n=8; 47%) and level I (n=7; 42%). Occasional drainage was identified at the peri-parotid node (n=1) and at level II (n=1). Contralateral drainage was noted in 2 patients (level I-1 and RPLN-1). Anterior injections drained predominantly to level I (6/8) and RPLN (2/8), while posterior injections drained predominantly to the RPLN (6/7). The relative risk of RPLN being identified as the sentinel node was significantly higher for posteriorly placed injections than for anteriorly placed injections (RR: 3.43; 95% CI: 1.0-11.8; P=.05). Conclusion The RPLN is noted as a frequent draining node for sino-nasal tumours and merits routine attention in all sino-nasal tumours. The radio-colloid SPECT-CT technique described here offers an excellent in vivo technique to further explore and validate the lymphatic drainage pathways of these tumours (AU)

In-vivo lymphoscintigraphy of sinonasal tumors identifies retropharyngeal node and level I as predominant sentinel nodes.

OBJECTIVE: To evaluate by in- vivo lymphoscintigraphy and SPECT-CT imaging, the lymphatic drainage patterns of para-nasal sinus(PNS) tumors. To confirm or refute the belief of the retropharyngeal lymph node (RPLN) being the significant draining lymph node for such tumors. METHODS: Prospective cohort study conducted on previously untreated PNS tumors with no clinico-radiological evidence of lymph node metastasis. Lymphoscintigraphy undertaken by nasal endoscopic assisted peritumoral injection of 99mTc Sulfur colloid. Injections were classified as anterior or posterior as per a vertical line along the maxillary sinus ostium. RESULTS: 17 patients were included. Lymphoscintigraphy successfully identified 17 sentinel nodes in 15 patients and was unsuccessful (lymphoscintigraphy failure) in 2 patients. Predominant sites of sentinel lymphatic drainage were noted to be the RPLN (n = 8; 47%), and Level I (n = 7; 42%). Occasional drainage was identified at the peri-parotid node(n = 1) and at Level II (n = 1). Contralateral drainage was noted in 2 patients (level I-1 and RPLN-1). Anterior injections drained predominantly to Level I (6/8) and RPLN (2/8), while posterior injections drained predominantly to the RPLN ( 6/7). The relative risk of RPLN being identified as the sentinel node was significantly higher for posteriorly placed injections than for anteriorly placed injections (RR- 3.43; 95% CI-1.0-11.8, p = 0.05). CONCLUSION: The RPLN is noted as a frequent draining node for sino-nasal tumours and merits routine attention in all sino-nasal tumors. The radio-colloid SPECT-CT technique described here offers an excellent in-vivo technique to further explore and validate the lymphatic drainage pathways of these tumours.

An economic and sustainable approach to transform aluminosilicate-rich solid waste to functionally graded composite foam for high-temperature applications.

The present study proposes an economical and effective approach for recycling coal overburden and similar solid wastes to fabricate lightweight and high-strength composite foam with industrial applications. Reaction-generated thermo-foaming technique has been used to develop functionally graded mullite-embedded silicate composite foam in a single step. The developed foams with gradient pores exhibit superior thermo-mechanical properties. In situ-growth of mullite phase within the silicate phase results in better mechanical strength of the foam. They possess bulk density, compressive strength and thermal conductivity in the range of 0.31-1.34 g/cm3, 2.97-15.06 MPa and 0.0843-0.2871 W/(m∙K), respectively. Thermal treatment irreversibly transforms the heavy metals present in the solid waste into stable mineral phases, further inhibiting the leaching of heavy metals from the developed foam. The developed foam with tuneable and gradient microstructure is seen as a potential material for thermal insulation and other applications such as refractories, molten metal and hot flue gas filters.

Optical coherence tomography application for assessing variation in bone mineral content: a preclinical study.

OBJECTIVE: Optical Coherence Tomography (OCT) is a non-invasive imaging technique that produces cross-sectional images through biological tissues, allowing three-dimensional reconstruction and analysis. Aim was to evaluate if OCT may discriminate among tissues with different bone density and composition, by measuring the depth of light penetration in porcine and rat bone samples. MATERIALS AND METHODS: Two carpal bone samples (2 cm length) were harvested from the porcine forelimb and fixed overnight in 3.7% buffered formal saline. Following fixation, one sample was decalcified in a 1:1 mixture of 8% hydrochloric acid and 8% formic acid solution for three days, with solution changes each day. Samples were imaged using an OCT microscope. Furthermore, the calvaria, ulnar, alveolar and basal bone of the mandible of 6 male and 6 female rats were cleared of overlying soft tissues and scanned under OCT. The light penetration depth in each sample was measured using the software Image J, and Scattering Attenuation Microscopy. RESULTS: In the mineralized bone the average depth (µm) and standard deviation (SD) of light penetration were 790.1±18.05 and 410.4±21.7 for periosteal and endosteal surface, respectively, and 507.3±21.03 for cross-section surfaces, while it was 858.4±32.03 for periosteal surface, 1150±26.9 for endosteal, and 627.3±31.8 for cross-section bone surfaces in demineralized porcine bone. There was a significant difference (p<0.001) in depth of light penetration between normal and de-mineralized bone for all regions evaluated. No systematic significant difference in light penetration depth between-gender was found at any site evaluated, while there were variations between sites (p<0.001). The OCT detected differences in bone mineral and porosity among gender (p<0.0001) CONCLUSIONS: This study suggests that OCT may represent a valuable technique to estimate local variations in bone mineral content.

Clinical and histopathological profile of oral cancer: a quadrennial analysis of Regional Cancer Centre of Odisha, India.

OBJECTIVE: To contribute toward the identification of population-based clinical and histopathological profile of oral squamous cell carcinoma (OSCC), this study was undertaken at the Regional Cancer Centre of Odisha (AHRCC), India. PATIENTS AND METHODS: This retrospective study included all patients diagnosed with OSCC registered at AHRCC, Odisha from 1st January 2015 to 31st December 2018. Demographic, clinical, and pathological data of each patient were retrieved from patient records. Patients with incomplete records were excluded. No postoperative treatment details were collected. RESULTS: The study included 851 cases of OSCC with the mean age of the population found to be 53.8±14.2 years. Male to female ratio was found to be 2.18:1. Gingivobuccal complex was the most common site of OSCC. While 679 patients were reported to undergo incision biopsy only 172 patients underwent excision biopsy in four years. Well differentiation (n=782) is the most common histological grading. The median clinical size of the tumour was 4 cm. Upon analyzing histological parameters in excision specimens lymphovascular and perineural invasion were seen in 38 and 26 cases, respectively. Cervical lymph node metastasis was seen in 42 cases out of 172 excision specimens (24%). 63.23% of cases presented with a depth of invasion between 5 to 10 mm. CONCLUSIONS: This is the largest comprehensive data from the regional cancer center of Odisha population which highlights the demographic, clinical, and histopathological data reported to date.

Pharmacokinetics and tissue distribution of florfenicol and florfenicol amine in snubnose pompano (Trachinotus blochii) following oral administration.

The present study reports the comparative pharmacokinetic profiles of florfenicol and its metabolite (florfenicol amine, FFA) in Trachinotus blochii under tropical marine conditions (salinity: 35 ± 1.4‰; temperature: 28.8 ± 0.54 °C) following a single in-feed oral administration of the recommended dose (15 mg/Kg). Furthermore, the study investigated the distribution of these two compounds in nine different tissues. The maximum florfenicol concentrations (Cmax) in plasma and tissues were observed within five hours (Tmax), except for bile. The Cmax ranged from 572 to 1954 ng/g or ml and was in the intestine > bile > muscle + skin > liver > gill = heart > plasma > kidney = spleen. The elimination half-life of FFC was significantly slower in the bile (38.25 ± 4.46 h). The AUC tissue/plasma was highest for bile (3.77 ± 0.22), followed by intestine > muscle + skin > heart > liver > kidney = gill = spleen. Tmax and t1/2ß were slower, and Cmax was lower for FFA than florfenicol in all tissues except Cmax of the kidney and bile. FFA t1/2ß was exceptionally slower in the kidney (46.01 ± 8.2 h). Interestingly, reaching an apparent distribution rate of > 0.5 was comparatively faster in the kidney, liver, and gills than in other tissues. The highest apparent metabolic rate was in the kidney (0.95 ± 0.01) and the lowest in plasma (0.41 ± 0.01). The generated data can be applied for formulating efficient therapeutic protocols in T. blochii, a promising mariculture species.

Vaccination saves lives: a real-time study of patients with chronic diseases and severe COVID-19 infection.

OBJECTIVES: This study aims to describe the demographic and clinical profile and ascertain the determinants of outcome among hospitalized coronavirus disease 2019 (COVID-19) adult patients enrolled in the National Clinical Registry for COVID-19 (NCRC). METHODS: NCRC is an on-going data collection platform operational in 42 hospitals across India. Data of hospitalized COVID-19 patients enrolled in NCRC between 1st September 2020 to 26th October 2021 were examined. RESULTS: Analysis of 29 509 hospitalized, adult COVID-19 patients [mean (SD) age: 51.1 (16.2) year; male: 18 752 (63.6%)] showed that 15 678 (53.1%) had at least one comorbidity. Among 25 715 (87.1%) symptomatic patients, fever was the commonest symptom (72.3%) followed by shortness of breath (48.9%) and dry cough (45.5%). In-hospital mortality was 14.5% (n = 3957). Adjusted odds of dying were significantly higher in age group ≥60 years, males, with diabetes, chronic kidney diseases, chronic liver disease, malignancy and tuberculosis, presenting with dyspnoea and neurological symptoms. WHO ordinal scale 4 or above at admission carried the highest odds of dying [5.6 (95% CI: 4.6-7.0)]. Patients receiving one [OR: 0.5 (95% CI: 0.4-0.7)] or two doses of anti-SARS CoV-2 vaccine [OR: 0.4 (95% CI: 0.3-0.7)] were protected from in-hospital mortality. CONCLUSIONS: WHO ordinal scale at admission is the most important independent predictor for in-hospital death in COVID-19 patients. Anti-SARS-CoV2 vaccination provides significant protection against mortality.

Do extraglomerular microvasculature and mesenchymal interstitial cell proliferation indicate a stable course of lupus nephritis?

Background: Lupus Nephritis (LN) is a major and frequent manifestation of Systemic Lupus Erythematosus (SLE), an autoimmune disease. Renal biopsy has a pivotal role in the diagnosis, prognosis, and management of the LN. The aim of this study was to count the mesenchymal interstitial cells utilizing CD34 immunohistochemistry (IHC) and morphometric analysis, correlate them with clinical parameters, class, activity, and chronicity indices and see if it can predict the course of the disease. Methods: A total of 32 renal biopsy blocks were analyzed by H&E stain, special stains, and CD34 IHC. Microvasculature density and interstitial stem cells were highlighted by CD34. These were then counted using a previously standardized computerized digital photomicrograph system (Dewinter Optical Inc) and manual count, respectively. Results: Out of the 32 cases, Lupus class 3 comprised of 11 (34.38%) cases, class 4 comprised of 16 (50%) cases, and mixed class 4 + 5 had 5 (15.62%) cases. It was found that CD34 expression in the microvasculature (for both microvascular density and mean vascular lumen diameter) decreased in patients of Lupus Nephritis with higher disease activity (p < 0.05). Although not statistically significant, the number of interstitial stem cells increased with lower disease activity. A statistical significance was found between serum total protein, serum albumin, and serum creatinine among the three groups of LN. Conclusion: Immunohistochemical staining of renal biopsy with CD34 may be used as a surrogate marker of disease activity in Lupus Nephritis patients.

Clinical Profile, Treatment, and Outcome of Patients with Secondary Hemophagocytic Lymphohistiocytosis in Critically Ill Patients: A Prospective Observational Study.

Introduction: The objective of the study was to evaluate the clinical profile and outcome of patients with secondary hemophagocytic lymphohistiocytosis (HLH) in critically ill patients. Materials and methods: A prospective observational study was conducted where critically ill adult patients presenting with fever and bicytopenia were evaluated according to the HLH-2004 diagnostic criteria for the presence of secondary HLH. The underlying trigger, clinical profile, treatment, and outcome of patients with HLH were analyzed. Results: Of the 76 critically ill patients with fever and bicytopenia, 33 (43%) patients were diagnosed with HLH. The following triggers for HLH were identified: bacterial infections (23%), fungal infections (10%), viral infections (10%), parasitic infections (10%), autoimmune diseases (13%), and malignancy (8%). A total of 78% of the HLH cases received steroids, but the use of steroids was not associated with improvement in mortality. Conclusion: There is a high prevalence of HLH in patients presenting with fever and bicytopenia in critically ill adult patients. Infections were identified as the most common trigger of HLH. How to cite this article: Fazal F, Gupta N, Soneja M, Mitra DK, Satpathy G, Panda SK, et al. Clinical Profile, Treatment, and Outcome of Patients with Secondary Hemophagocytic Lymphohistiocytosis in Critically Ill Patients: A Prospective Observational Study. Indian J Crit Care Med 2022;26(5):564-567.

Dimensional and histomorphometric evaluation of biomaterials used for alveolar ridge preservation: a systematic review and network meta-analysis.

OBJECTIVES: This systematic review and network meta-analysis aimed to answer to the following questions: (a) In patients undergoing alveolar ridge preservation after tooth extraction, which grafting material best attenuates horizontal and vertical ridge resorption, as compared to spontaneous healing?, and (b) which material(s) promotes bone formation in the extraction socket? MATERIALS AND METHODS: The MEDLINE, SCOPUS, CENTRAL, and EMBASE databases were screened in duplicate for RCTs up to March 2021. Two independent authors extracted the data and assessed the risk of bias of the included studies. Primary outcomes were ridge horizontal and vertical dimension changes and new bone formation into the socket. Both pairwise and network meta-analysis (NMA) were undertaken to obtain estimates for primary outcomes and compare different grafting materials. RESULTS: Eighty-eight RCTs were included, with a total of 2805 patients and 3073 sockets. Overall, a total of 1740 sockets underwent alveolar ridge preservation with different materials (1432 were covered by a membrane). Pairwise meta-analysis showed that, as compared to spontaneous healing, all materials statistically significantly reduced horizontal and vertical shrinkage. According to the multidimensional scale ranking of the NMA, xenografts (XG) and allografts (AG), alone or combined with bioactive agents (Bio + AG), were the most predictable materials for horizontal and vertical ridge dimension preservation, while platelet concentrates performed best in the percentage of new bone formation. CONCLUSIONS: Alveolar ridge preservation is effective in reducing both horizontal and vertical shrinkage, as compared to untreated sockets. NMA confirmed the consistency of XG for ridge dimension preservation, but several other materials and combinations like AG, Bio + AG, and AG + alloplasts, produced even better results than XG in clinical comparisons. Further evidence is needed to confirm the value of such alternatives to XG for alveolar ridge preservation. Bio + AG performed better than the other materials in preserving ridge dimension and platelet concentrates in new bone formation. However, alloplasts, xenografts, and AG + AP performed consistently good in majority of the clinical comparisons. CLINICAL RELEVANCE: XG and Bio + AG demonstrated significantly better performance in minimizing post-extraction horizontal and vertical ridge dimension changes as compared with other grafting materials or with spontaneous healing, even if they presented the worst histological outcomes. Allografts and other materials or combinations (AG + AP) presented similar performances while spontaneous healing ranked last.

Evaluating newly approved drugs for multidrug-resistant tuberculosis (endTB): study protocol for an adaptive, multi-country randomized controlled trial.

BACKGROUND: Treatment of multidrug- and rifampin-resistant tuberculosis (MDR/RR-TB) is expensive, labour-intensive, and associated with substantial adverse events and poor outcomes. While most MDR/RR-TB patients do not receive treatment, many who do are treated for 18 months or more. A shorter all-oral regimen is currently recommended for only a sub-set of MDR/RR-TB. Its use is only conditionally recommended because of very low-quality evidence underpinning the recommendation. Novel combinations of newer and repurposed drugs bring hope in the fight against MDR/RR-TB, but their use has not been optimized in all-oral, shorter regimens. This has greatly limited their impact on the burden of disease. There is, therefore, dire need for high-quality evidence on the performance of new, shortened, injectable-sparing regimens for MDR-TB which can be adapted to individual patients and different settings. METHODS: endTB is a phase III, pragmatic, multi-country, adaptive, randomized, controlled, parallel, open-label clinical trial evaluating the efficacy and safety of shorter treatment regimens containing new drugs for patients with fluoroquinolone-susceptible, rifampin-resistant tuberculosis. Study participants are randomized to either the control arm, based on the current standard of care for MDR/RR-TB, or to one of five 39-week multi-drug regimens containing newly approved and repurposed drugs. Study participation in all arms lasts at least 73 and up to 104 weeks post-randomization. Randomization is response-adapted using interim Bayesian analysis of efficacy endpoints. The primary objective is to assess whether the efficacy of experimental regimens at 73 weeks is non-inferior to that of the control. A sample size of 750 patients across 6 arms affords at least 80% power to detect the non-inferiority of at least 1 (and up to 3) experimental regimens, with a one-sided alpha of 0.025 and a non-inferiority margin of 12%, against the control in both modified intention-to-treat and per protocol populations. DISCUSSION: The lack of a safe and effective regimen that can be used in all patients is a major obstacle to delivering appropriate treatment to all patients with active MDR/RR-TB. Identifying multiple shorter, safe, and effective regimens has the potential to greatly reduce the burden of this deadly disease worldwide. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02754765. Registered on 28 April 2016; the record was last updated for study protocol version 3.3, on 27 August 2019.

Dental implant survival rate in irradiated and non-radiated patients: a systematic review and meta-analysis.

Radiotherapy to head and neck has always been considered as a risk factor for rehabilitation with dental implants. Nevertheless, recent data suggest that overall, 5-year implant survival in irradiated patients can be greater than 90%. The purpose of this review was to compare the implant survival rates of irradiated and non-radiated head and neck cancer sites, and discuss the outcomes, through a systematic review approach of prospective and retrospective studies. Electronic searches were performed in the EMBASE, Cochrane, and PubMed/Medline databases up to 2019 Dec, to identify retrospective and prospective clinical studies addressing the subject. This systematic review was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The primary variables collected from the studies were the site of tumor, age and sex of the patient, site of implant placement, radiation dosage, frequency and duration of radiotherapy, follow-up duration, implant survival and stability, hard and soft tissue changes after implant placement, any type of biological and mechanical complication, and oral health quality of life (QOL). Fifteen studies including 1097 patients and a total of 4637 implants placed in irradiated and non-irradiated sites, with a follow up duration varying from 6 to 120 months, were selected for the systematic review. The results of the quantitative synthesis suggested statistically significantly better survival rate of implants placed in nonradiated sites, as compared to irradiated sites (p<0.00001). However, the cumulative survival rates over a period of 7-10 years were reported to be comparable. Quality of life (QOL) after implant rehabilitation was not found to be significantly different between the compared groups. Due to the limited number of information, insufficient data was available to draw conclusion on peri-implant complication rate. No relationship was found between age, gender, and implant survival rates. Implant placement in irradiated sites is challenging and often warrants protocol modifications. Although statistically the survival rates at irradiated sites were lower in comparison to non-radiated sites, a strict inclusion criterion in patient selection, timing of implant placement after radiotherapy, radiation dosage and regular oral hygiene maintenance could minimize the chances of implant failure in irradiated patients.

Clinical effectiveness of Lactobacillus reuteri in the treatment of peri-implant diseases: a systematic review and meta-analysis.

In the last decades, the presence of peri-implant diseases (PD) has increased. One of the therapies currently used is probiotics with Lactobacillus reuteri (LR). The aim of this article is to determinate, through a systematic review and meta-analysis, the clinical effectiveness of LR in the treatment of PD. We searched the literature until January 2021, in the biomedical databases: Pubmed, Embase, Scielo, Science Direct, Scopus, SIGLE, LILACS, Google Scholar and Cochrane Central Registry of Clinical Trials. The selection criteria of the studies were: randomized controlled clinical trials, without language and time restriction, reporting the clinical effects (depth to probing, plaque index and bleeding index) of the LR in the PD treatment. The risk of study bias was analyzed through the Cochrane tool for randomized studies using Review Manager software. The search strategy resulted in 6 articles of which four investigated peri-implantitis and three peri-implant mucositis. All studies reported that there was a difference in the depth of the probing in the treatment of PD, in favor of the group using LR, though not always achieving significance. The use of LR can be clinically effective in terms of pocket depth reduction in the treatment of PD.

Role of probiotics in adjunct to non-surgical periodontal therapy in patients with chronic periodontitis: a systematic review and meta-analysis.

The objective of this study was to establish the significance of probiotic usage, both as a preventive as well as a therapeutic strategy for the management of periodontal disease. It also substantiates the existing studies of single/combined bacterial strain for exhibiting variable ecological impact on oral bacteria. Data sources included literature searches of PubMed (MEDLINE), Scopus, Embase, CENTRAL and Web of science databases for placebo controlled randomized clinical trials of SRP with orally administered probiotics in any form as an adjunct. Data extraction was conducted and information from the included studies was tabulated according to the study designs, form of drug delivery, main outcomes, and clinical parameters. Data collected were based on the focused question outlined for the present systematic review. The reviewers cross-checked all extracted data. CAL and PD were assessed as the primary outcome to compare the effectiveness of adjunctive probiotic therapy in addition to SRP. Fourteen clinical studies were included and demonstrated efficacy in reducing periodontal probing depth (PPD) and gaining clinical attachment level (CAL), between probiotics and SRP/placebo. Adjunctive probiotic therapy in addition to SRP leads to decrease in probing depth and clinical attachment gain in chronic periodontitis patients. However, further high-quality randomized clinical trials with microbiological outcomes are required to fortify the conclusion.

Clinical efficacy of grape seed extract as an adjuvant to scaling and root planing in treatment of periodontal pockets.

Grape seed extract (GSE), a naturally producing polyphenolic compound, is found to be a potent hostmodulatory agent and considered for management of periodontal disease. Its anti-bacterial, antioxidant, and anti-inflammatory property may aid in achieving periodontal health. To assess the clinical efficacy of GSE in adjunct to scaling and root planing (SRP) in healing of periodontal pockets. The present study was a longitudinal, parallel design, randomized clinical trial. Seventy-two patients (mean age 39.2±8.6 years) with periodontal pockets were randomly divided into two groups; Test group received intra-pocket delivery of GSE with SRP and Control group received SRP alone. The clinical parameters like Plaque Index (PI), Gingival Index (GI), Probing Depth (PD) and Relative Attachment Level (RAL) were recorded at baseline and 3 months. 64 patients completed the study. Test group at the end of 3 months had statistically significant reduced PD (p=0.002) and RAL (p=0.01). No significant difference was observed for PI and GI at the end of 3 months. Intra-pocket application of GSE with SRP could be beneficial in management of periodontal pockets.

Contribution of Indian researchers in high impact periodontal journals: a bibliometric analysis of last three years.

Bibliometric Analysis researches and analyses the quantitative data derived from scientific publications through the empirical evidence of scientific activity generated by collaborating authors through the final product of their research: the scientific article. In scientific society, the concept of impact factor is probably the most widely used in bibliometric construction. To assess the scientometrics of three high-impact factor periodontal journals and identify the contribution of India in these most productive journals over three years (Jan 2018 - Dec 2020) and to know the most influential topics researched. A retrospective observational study was conducted for the Journal of Clinical Periodontology, Journal of Periodontology, and Journal of Periodontal Research. All issues of 2018, 2019, and 2020 were electronically and hand searched for the following parameters: Number of papers, affiliated organizations, and countries, topics reported, and contribution of Indian authors. The data were organized and analyzed with descriptive statistics using SPSS software (version 21.0). In total 469 articles were published by Journal of Periodontology, followed by 454 articles in Journal of Clinical Periodontology and 287 articles in Journal of Periodontal Research. In all the three journals, China had the maximum contributions, succeeded by USA. India has published maximum number of articles in the Journal of Periodontal Research. When analysed, although less as compared to the western counterparts, an increasing trend in the publications is seen in case of India.

Chemometrics supported optimization of a multi-attribute monitoring liquid chromatographic method for estimation of palbociclib in its dosage form: Application to a new regulatory paradigm.

OBJECTIVE: The objective of present work was to develop a validated liquid chromatographic method for the estimation of palbociclib in its solid dosage forms by employing a new systematic concept. MATERIAL AND METHOD: Risk assessment and control measures were undertaken along with chemometrics assistance to establish the robust method performance for studied analytical attributes viz. analyte retention, resolution, plate number, and tailing factor. Methanol %, flow rate, and pH were found influential on the performance of studied analytical attributes and optimized using a Box-Behnken experimental design. Monte-Carlo simulation was performed to evaluate the performance of the analytical procedure. A multi-attribute monitoring liquid chromatographic method employing methanol: 0.01M KH2PO4 buffer of pH 3.5 (70:30, v/v) was used with a reversed-phase column. Flow rate at 1.2mL/min and detection at 265nm monitored peak responses. RESULT: The method efficiently separated analyte from the internal standard caffeine (resolution>16). Specificity (resolution>2.0), linearity (2-64µg/mL), accuracy (>99%) and precision (%RSD<1%) were well in accord with regulatory requirements. Further, analyte was detected at 1µg/mL and was stable over applied stress conditions. CONCLUSION: In a nutshell, the novel approach produced an accurate method for estimation of palbociclib in tablets with optimum method performance.