Triple-blind Study Research Articles

Ropivacaine with Bupivacaine-lidocaine Mixtures used in Peribulbar Blocks for Cataract Surgery: A Randomised, Triple-blind Clinical Study

Introduction: Till recently, for providing anaesthesia for cataract surgeries peribulbar blocks were most commonly employed using various proportions of 0.5% bupivacaine and 2% lidocaine mixtures. As both these anaesthetic agents were reported to produce cardiovascular and Central Nervous System (CNS) side-effects, safer agents like levobupivacaine and ropivacaine are being introduced into clinical practice. Aim: To make a comparative evaluation of the characteristics of peribulbar blocks with 0.75% ropivacaine vis-à-vis the popularly used bupivacaine plus lidocaine mixtures. Materials and Methods: A randomised, triple-blind clinical study was undertaken between August 2021 and December 2021 comparing ropivacaine versus bupivacaine-lidocaine mixtures. A total of 90 patients attending the hospital for cataract surgeries were allocated into three groups of 30 each. Peribulbar blocks were given with 6 mL of 0.75% ropivacaine in group R, 6 mL of 1:1 mixture of 0.5% bupivacaine and 2% lidocaine in group BL, and 6 mL of 1:1 mixture of 0.5% bupivacaine and 2% lidocaine with adrenaline in groups BLA. The primary outcome measure was the total duration of analgesia (pain in the eye of grade >2). The secondary outcome measures studied were the time to onset of the motor and sensory blocks, the total analgesic requirement in the first 24 hours after surgery and changes in the Intra-Ocular Pressures (IOP) after administration of the block. For statistical analysis, Analysis of Variance (ANOVA) and posthoc test of Tukey’s Honestly Significant Difference were used for parametric data and Chi-square test was used for non parametric data and a p-value of 0.05 was considered statistically significant. Results: The demographic characteristics and the baseline vital signs were comparable in all the three groups. Duration of the analgesia of the block was 4.2±0.79 hours, 3.6±1.08 hours, and 3.8±0.55 hours in groups R, BL and BLA, respectively. The total duration of analgesia was significantly longer in group R. The total analgesic consumption was 58.3 ±18.9,75±25.42 and 68.3±24.5 and patients of group R had a significantly decreased consumption. There was a significant reduction in IOP in the patients of group R compared to other groups and the differences observed at 5 minutes,10 minutes and 25 minutes intervals were found to be statistically significant. Burning sensation in the eyes while injecting the drug for the peribulbar block was reported by 2, 10 and 12 patients respectively in groups R, BL and BLA and the patients of group R were found to have less number of burning sensation episodes which was statistically significant (p-value=0.0084). More number of patients and surgeons in groups R had greater satisfaction levels. Conclusion: In peribulbar blocks, 6 mL of 0.75% ropivacaine produces satisfactory block characteristics with prolonged analgesia, reduced IOP, stable haemodynamics and optimal surgical operating conditions and patient satisfaction levels.

Comparative efficacy of bromelain and aceclofenac in limiting post-operative inflammatory sequelae in surgical removal of lower impacted third molar: a randomized controlled, triple blind clinical trial.

BackgroundPain, edema, and trismus are predictable sequelae for surgical extraction of impacted mandibular third molars (M3M). The present study aimed to compare the anti-phlogistic potential of bromelain and aceclofenac in the reduction of post-surgical sequalae in the extraction of impacted M3M.MethodA randomized controlled, triple-blinded clinical study included 72 patients scheduled for surgical removal of impacted M3M under local anesthesia. Randomization was performed and subjects were equally allocated to groups A (control) and B (study), who intended to receive aceclofenac and bromelain, respectively. The primary outcome variables were pain, edema, and trismus evaluated on postoperative days 2 and 7 and compared with baseline values. The secondary variables evaluated were the quantity of rescue analgesics required and the frequency of adverse effects in both groups for 7 postoperative (PO) days. Data were analyzed with a level of significance of P < 0.05.ResultsGroup B demonstrated a significant decrease in the severity of edema and trismus compared to group A on both PO days 2 and 7 (P < 0.001). Bromelain demonstrated similar analgesic efficacy with an insignificant difference compared to aceclofenac (P > 0.05).ConclusionThe present study showed that the efficacy of bromelain was comparable to that of aceclofenac in reducing inflammatory complications following surgical removal of impacted M3M. Bromelain can be considered a safe and potent alternative to routinely used aceclofenac when addressing inflammatory outcomes after surgery.

Comparing the Efficacy of Premedication with Ibuprofen in Combination with an Inferior Alveolar Nerve Block and Primary Buccal Infiltration in Mandibular Molars with Irreversible Pulpitis: A Triple-blinded Randomized Clinical Trial.

This study aimed to determine the success rate of the combination of buccal infiltration (BI) and inferior alveolar nerve block (IANB) injections in irreversible pulpitis in mandibular molars after premedication with ibuprofen. From 132 patients participated in the study, 120 patients were included. One hour before root canal treatment, patients with mandibular molars with symptomatic irreversible pulpitis received either a 600 mg ibuprofen capsule or a placebo. All patients received 2% lidocaine with 1:80000 epinephrine and 4% articaine with 1:100000 epinephrine for IANB and BI, respectively. Patients' pain was evaluated using the Heft-Parker visual analog scale during the preparation of access cavity, exposure of pulp, and instrumentation of root canal. The success of anesthesia was defined as the absence of pain or mild pain. The Chi-square and t-test were employed for data analysis. The difference between patient age and gender in the two groups was not significant (P>0.05). The anesthesia success rate was 85% in the premedicated and 70% in the placebo group, with statistically significant results (P=0.049). Based on this triple-blinded randomized clinical study, mandibular molars with irreversible pulpitis were not thoroughly anesthetized by a combination of IANB+BI after premedication with ibuprofen (600 mg), even though anesthesia success was improved significantly by ibuprofen premedication.

A comparative study of the effects of dexmedetomidine added as an adjuvant to bupivacaine, levobupivacaine, and ropivacaine in the brachial plexus blocks: A prospective randomized triple-blind study

A comparative study of the effects of dexmedetomidine added as an adjuvant to bupivacaine, levobupivacaine, and ropivacaine in the brachial plexus blocks: A prospective randomized triple-blind study

Deferasirox on COVID-19: safety and efficacy of iron-chelating therapy. A multicentric, randomized, triple blinded study

Background and Rationale: SARS-CoV-2, the virus that causes COVID-19, can cause a multitude of health effects. One of the registered effects of COVID-19 is hyperferritinemia due to an excess of necrotic cells and mitochondrial load spread, generating high levels of iron and ferritin. Deferasirox (Exjade®), an iron-chelating agent, has been proposed to treat COVID-19 patients with hyperferritinemia. The objective of this investigation is to submit estimations with high levels of fidelity about the effect of the treatment and the severity of the patients administered the drug blindly in a cohort of hospitals in the city of Santiago, Dominican Republic. Methods: Multicentric study, randomized, triple-blind of parallel groups to evaluate the effects of Deferasirox and standard therapy in patients hospitalized for COVID-19 and hyperferritinemia versus therapy standard for COVID-19. A sample of 94 participants (47 in each group) is necessary to detect the effects of the treatment measured as progressing and becoming severe while being hospitalized. Discussion: Clinical evidence has shown the efficacy and safety of Deferasirox and its use in admitted patients with COVID-19 and hyperferritinemia. Based on this, by executing a retrospective analysis, the authors of this protocol Performed a successful security analysis in Deferasirox patients, noticing that their mortality was not greater, avoiding severity and also suggesting an improvement in the biomarkers. Keywords: Deferasirox, COVID-19, Hyperferritinemia

Abstract 12506: Exploring the Absence of an Intervention: A Randomized, Placebo-Controlled, Triple Blind Study on Notoginseng Supplementation in A Population With Normal to Mild Hypertension and Hypercholesterolemia

Introduction: The concept of a lack of intervention in a pre-disease population with hypercholesterolemia has not been previously reported. This study examined the concept of the effects of the absence of an intervention in the placebo group vs. supplementation of a special formulation of Panax Notoginseng (FNG) in relation to cardiovascular disease (CVD) risk markers and validated CVD-risk factor scores. Methods: Participants in this randomized, placebo-controlled, triple-blind study were supplemented with FNG or placebo for 12 weeks. Lipid profile, blood pressure (BP), and endothelial vasodilation parameters were assessed at baseline and weeks 4, 8 and 12 and safety assessed at screening and end of study. The participants in both groups followed the Therapeutic Lifestyle Change (TLC) diet during a 4-week run-in and throughout the study. The TLC diet for 4 weeks ensured all participants starting the study had similar baseline measurements and placebo effects were adequately addressed. Results: Participants in the placebo group had a non-significant 1.37% reduction in HDL-C at 8 and 12 weeks, as well, as an increase in systolic BP from baseline at week 12. Participants in the placebo had no change in estimated Framingham Heart Study 10-year risk for CVD, while the FNG group had a 0.1% reduction from baseline at week 12. A total of 67.5% of participants supplemented with FNG had improvements in at least two CVD risk factors (LDL-C, HDL-C and systolic BP) compared to 40.0% of those on placebo (p=0.007). In a post-hoc subgroup analysis of participants with baseline LDL-C &gt;3.5 mmol/L, 41.7% of participants in the FNG group had reductions in their systolic BP and LDL-C and improvements in HDL-C levels at week 12, compared to placebo where there were no improvements. Conclusions: The lack of an intervention in a population at risk of CVD, represented by the placebo group, resulted in a negative impact on cardiovascular risk factors and warrants further investigation on the importance of pre-emptive supplementation of notoginseng in populations with mild hypertension and hypercholesterolemia. This study supports a previously defined concept in nutritional interventions which described changing from proof of efficacy to that of probable harm in pre-disease populations.

A Randomized, Placebo-controlled, Triple-blind Study to Determine the Effect of Farlong Ginseng Plus® NotoGinseng Extract on Cholesterol and Blood Pressure

Objective: This randomized, placebo-controlled, triple-blind study examined the efficacy of 12 weeks of Farlong NotoGinsengTM (FNG) supplementation on LDL-C and blood pressure (BP) in otherwise healthy participants (n=95) with normal to mild hypertension and hypercholesterolemia. Methods: Lipid profile, BP, and endothelial vasodilation parameters were assessed at baseline and weeks 4, 8 and 12. Safety was assessed at screening and at end of the study. The Therapeutic Lifestyle Change (TLC) diet was followed during a 4-week run-in and throughout. Results: Participants on FNG had a 4.33% reduction in LDL-C at week 8 (p=0.045) and a 1.80% improvement in HDL-C at week 12. Those on placebo had a non-significant 1.37% HDL-C reduction at both weeks 8 and 12. The FNG group showed a 0.94% reduction in systolic (SBP) and a 0.16% reduction in diastolic BP (DBP) at week 12. The placebo group had 0.5% and 1.24% increases in SBP and DBP, respectively. A total of 17.5% of participants supplemented with FNG had improvements in all three CVD risk factors (LDL-C, HDL-C, and SBP) compared to 5.0% of those on placebo (p=0.040). A greater proportion of participants with borderline high baseline LDL-C had reductions in their CVD risk factors (p=0.037) with FNG. However, participants in the placebo group with similar LDL-C characteristics did not have improvements in either their BP or lipid profile. Conclusion: FNG was well-tolerated and may have a positive influence on reducing CVD risk by improving BP and lipid profile. Left unaddressed, those with CVD risk factors may progress to a more hypertensive and hypercholesterolemic state.

" Comparative study of the effect of "Ginger-Lavender" capsule with Mefenamic Acid" on the severity of primary dysmenorrhea, A controlled experimental study

Introduction:Dysmenorrhea is a major problem in women's general and individual health. The aim this study was to compare effect ofGinger-Lavendercapsule on severity primary dysmenorrhea. Methods: A triple-blind clinical trial study was performed on 60 students living in dormitories Shahid Beheshti University in 1399 with a history dysmenorrhea .In intervention group 500mg capsules of and in control group 250mg capsules Mefenamic in similar capsules were prescribed.The mean and mean differences in pain intensity between groups were assessed by SPSS 24 using t-test, Bonferroni and Analysis Variance.Results: Before intervention there was no significant difference between groups in terms pain intensity(p=0.22). In first and second cycle after intervention between groups using two-factor statistical test showed a significant difference(p<0.05). Intra-group one-factor test with comparison three cycles showed a statistically significant difference in group ginger-lavender (p=0.001)and Mefenamic Acid (p=0.00), Bonferroni test in both groups showed a significant difference between mean pain intensity before intervention with first and second cycle (p=0.00).Analysis Variance showed that mean pain score in group was 1.53 less than the Acid capsule. There was a significant difference in duration bleeding compared to three cycle in Ginger-Lavender group.(p=0.07)Conclusion:The results study showed Ginger-Lavender capsule reduces pain primary dysmenorrhea without any serious side effects and is more effective than Acid.

Obturator nerve block does not provide analgesic benefits in total hip arthroplasty under multimodal analgesic regimen: a randomized controlled trial

Background and objectivesAlthough regional analgesia is considered an important component of optimal pain management, use of peripheral nerve blocks for total hip arthroplasty remains controversial. Since the obturator nerve innervates...

Do natural ingredients in a dentifrice contribute to prevention of plaque and gingivitis?

ObjectiveTo test the effectiveness of a dentifrice containing the turmeric and licorice extract compared to a control for preventing plaque and gingivitis over a four‐month period.Material and methodsNinety (non‐dental) participants with moderate gingival inflammation (≥ 40%) were selected. The triple blind study consisted of two phases, namely at first a 3‐week pre‐experimental phase of using an oxygenating and chlorhexidine (CHX) mouthrinse. Secondly, a 4‐month experimental period in which participants were randomly assigned to a test or control group. All were instructed to brush their teeth twice daily for 2 minutes with their assigned dentifrice. Gingival bleeding (BI), plaque (PI) and gingivitis (GI) were assessed.ResultsEighty participants completed the protocol. At the first assessment in the pre‐experimental phase, the mean scores of all indices showed no differences for the two groups. At the second session, the values of all three parameters had decreased significantly (p < 0.001). At the last session, the BI values were 0.52(0.25) for the test group and 0.56(0.25) for the control, the mean GI was 0.27(0.17) for the test group and 0.31(0.16) for the control, and for PI the scores were 1.89(0.46) for the test group and 1.98(0.43) for the control group. Statistical comparison of the scores for the two groups at each stage of the study showed no significant difference for any of the parameters.ConclusionWithin the limits of the current study design, dentifrice formulation and concentration of turmeric/licorice extracts, the results show that the adjuvant effect of the natural ingredients in the test dentifrice was not evident on clinical parameters of gingivitis and plaque.

P-EG008. Electroencephalographic changes on passive listening to 3 Indian classical music scales

Introduction . Music, though used predominantly as an entertainer, studies have shown that music has a significant effect on the body and the mind. But, most of the scientific evidences are now being created for western music (Mozart, Beethoven etc.). Unfortunately, evidence regarding the health benefits of Indian music is extremely meagre. In this study the effect of Indian music on health with special reference to electrophysiological parameters was evaluated. Sama Veda enlists the various scales (ragas) and their health benefits. Objective: To evaluate the effect of 3 select Indian classical ragas on stress markers and brain via electroencephalogram (EEG). Methods . In this triple blind study, 140 subjects aged 18-30 years were randomly divided into 3 groups (A, B, C, D; 35 in each group). The first 3 groups, received music intervention (3 ragas), while the group D served as control. Stress was measured before and after intervention using State Trait Anxiety Inventory (STAI). EEG (19 channel, Galileo NT) was recorded before, during and after music (each condition 10 min). Analysis of data was done using SPSS and BESS Software (Axxonet System Technologies Pvt. Ltd.) and MATLAB software (Mathworks). Results . The 3 groups were comparable. Stress reduced with all 3 ragas. Between conditions effects in theta, alpha, beta and gamma bands were observed which got restricted to only alpha band at right frontal region after collapsing the conditions. First 2 minutes data revealed predominant effects on raga A on theta, alpha, beta, gamma power; raga B on alpha, beta gamma power and raga C showed a significant difference all 5 wave power of EEG. Conclusion . Music reduced stress. It is the scale presented as a whole, as it unfolds, that affected the EEG. The significant hemispheric differences with each raga, particularly, frontal asymmetry is in line with the model of hemispheric specialization concerning perceived positive or negative emotions proposed by Heilman.

Estimating salivary carriage of severe acute respiratory syndrome coronavirus 2 in nonsymptomatic people and efficacy of mouthrinse in reducing viral load: A randomized controlled trial

BackgroundMany people infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) never develop substantial symptoms. With more than 34 million people in the United States already infected and highly transmissible variants rapidly emerging, it is highly probable that post- and presymptomatic people will form an important fraction of those seeking dental care. Salivary carriage rates in these populations are not known. Moreover, although preventing transmission is critical for controlling spread, the efficacy of mouthrinses in reducing oral viral load is poorly studied. MethodsThe authors recruited 201 asymptomatic, presymptomatic, postsymptomatic, and symptomatic people and measured copy numbers of SARS-CoV-2 in unstimulated saliva using real-time reverse transcriptase quantitative polymerase chain reaction. Subsequently, the authors inducted 41 symptomatic people into a randomized, triple-blinded study and instructed them to rinse with saline, 1% hydrogen peroxide, 0.12% chlorhexidine, or 0.5% povidone-iodine for 60 seconds. The authors measured viral load 15 and 45 minutes after rinsing. ResultsSalivary SARS-CoV-2 was detected in 23% of asymptomatic, 60% of postsymptomatic, and 28% of presymptomatic participants. Neither carriage rate nor viral load correlated with COVID-19 symptomatology, age, sex, or race or ethnicity. All 4 mouthrinses decreased viral load by 61% through 89% at 15 minutes and by 70% through 97% at 45 minutes. The extent of reduction correlated significantly with initial viral load. ConclusionsNonsymptomatic people can pose a risk of transmitting the virus, and mouthrinses are simple and efficacious means of reducing this risk, especially when the load is less than 104 copies per milliliter. Practical ImplicationsAt a time when resources are stretched, the findings of this study contribute to evidence-based selection of personal protection equipment and simple infection-control practices to reduce contagion at source.This clinical trial was registered at ClinicalTrials.gov. The registration number is NCT04603794.

A triple-blinded crossover study to evaluate the short-term safety of sweet manioc starch for the treatment of glycogen storage disease type Ia

BackgroundGlycogen storage disease type 1a (GSD Ia) is characterized by severe fasting hypoglycemia. The clinical management includes the administration of uncooked cornstarch (UCCS). Although such a diet approach is effective in achieving euglycemia, its impact on the quality of life of patients should be considered. In vitro analyses suggest a longer release of glucose when using sweet manioc starch (SMS).MethodsWe compared the efficacy and safety of the administration of SMS and UCCS during a short-fasting challenge in patients with GSD Ia in a randomized, triple-blind, phase I/II, cross-over study. GSD Ia patients aged ≥ 16 years and treated with UCCS were enrolled. Participants were hospitalized for two consecutive nights, receiving UCCS or SMS in each night. After the administration of the starches, glucose, lactate and insulin levels were measured in 1-h interval throughout the hospitalization period. The procedures were interrupted after 10 h of fasting or in a hypoglycemic episode (< 3.88 mmol/L).ResultsEleven individuals (mean age: 21.6 ± 4.3 years; all presenting body mass index > 25 kg/m2) participated in the study. The average fasting period was 8.2 ± 2.0 h for SMS and 7.7 ± 2.3 h for UCCS (p = 0.04). SMS maintained euglycemia for a greater period over UCCS. Increased lactate concentrations were detected even in absence of hypoglycemia, not being influenced by the different starches investigated (p = 0.17). No significant difference was found in total cholesterol, HDL, triglycerides and uric acid levels in both arms. None of the patients showed severe adverse events.ConclusionsSMS appears to be non-inferior to UCCS in the maintenance of euglycemia, thus emerging as a promising alternative to the treatment of GSD Ia.

Aspects of transition cow metabolomics—Part II: Histomorphologic changes in the liver parenchyma throughout the transition period, in cows with different liver metabotypes and effects of a metaphylactic butaphosphan and cyanocobalamin treatment

The aims of this study were to evaluate histopathologic changes during the transition period, describe the histopathological features of the metabotypes identified in Part I (Schären et al., 2021b), and investigate effects of a metaphylactic treatment with butaphosphan and cyanocobalamin (BCC) on the liver parenchyma. Eighty German Holstein cows (mean 305-d production: 10,957 kg, range: 6,480-15,193 kg; mean lactation number: 3.9, range: 2-9) from a commercial dairy farm in Saxony, Germany, were enrolled in a randomized, prospective, triple-blinded study. Two groups received a treatment with BCC (5 or 10 mL/100 kg of body weight 10% butaphosphan and 0.005% cyanocobalamin, Catosal, Bayer Animal Health, n = 20 each) and one group a placebo treatment (NaCl 0.9%, n = 40). Liver biopsy specimens were collected 14 d antepartum (AP) and 7, 28, and 42 d postpartum (PP), routinely processed for histologic examination, and stained with hematoxylin and eosin, Sudan III, periodic acid-Schiff, and picrosirius red stains. The sections were assessed for fat and glycogen content and degenerative, inflammatory, fibrotic, and proliferative changes. The statistical analysis included the effects of the sampling day, the lactation number, the treatment, and the metabotype (A = medium, B = minor, C = large alterations in the liver metabolome profile between AP and PP status). There was mild to moderate fat infiltration in the liver of 37% of cows in the last 2 wk AP, and moderate to severe fat infiltration in 66% of cows in the first days PP. The degree of fat infiltration increased from 2 wk AP until the end of the first week PP, and then decreased until the end of the study period, at which time about 25% of cows had moderate to severe fatty infiltration. Lipidosis was positively correlated with the severity of liver cell degeneration, and negatively correlated with the degree of glycogen deposits. Complete glycogen depletion of hepatocytes was not observed in cows, even in the presence of severe hepatic lipidosis. Moderate to severe lymphocytic hepatitis was seen in 39% of cows throughout the study period, and cows with lactation numbers 5 or greater had perisinusoidal fibrosis more often than younger cows. Severe fibrosis and cirrhosis of the liver did not occur. Metabotype B animals exhibited a higher chance of fatty infiltration, lower glycogen storage, and perisinusoidal fibrosis and for this metabotype positive correlations were calculated between increased fat deposition in the liver and marked glycogen depletion, and increased degenerative, inflammatory, fibrotic, and proliferative changes of hepatic tissue. For the treatment with BCC, no significant effect was observed. In summary, during the transition period, the liver of dairy cows is characterized by fat accumulation and glycogen depletion and histologic signs of hepatitis and hepatocyte degeneration. These histomorphologic changes were accentuated in animals exhibiting little alterations in their liver metabolome profile across the transition period (metabotype B) and support the assumption of a decreased grass silage quality as a causative factor.

Comparing Different Doses of Dexmedetomidine in Attenuating Extubation Response in Hypertensive Patients Undergoing Laparoscopic Cholecystectomy

Abstract Background: Tracheal extubation is always linked with hypertension, tachycardia, and high-plasma catecholamine levels. These hemodynamic fluctuations are seen more often in hypertensive patients than in normotensives. The present study evaluates the effects of three different doses of dexmedetomidine in hypertensive patients relative to each other in attenuating extubation response. Patients and Methods: In this randomized, controlled, triple-blinded study, 105 controlled hypertensive patients of either sex on antihypertensive drugs in the age group of 30–70 years, scheduled for laparoscopic cholecystectomy were included. They were randomized into Groups A, B, and C receiving 0.5 μg/kg, 0.75 μg/kg, and 1 μg/kg of dexmedetomidine 10 ml infusion 10 min before extubation. Hemodynamic parameters in form of pulse rate, systolic and diastolic blood pressure, mean arterial pressure (MAP), oxygen saturation, and bispectral index (BIS) were noted. Extubation time, quality, and sedation were evaluated. Any side effects in form of postoperative nausea, vomiting, and bradycardia were noted. Results: There was significant attenuation of rise in heart rate, systolic, diastolic, and MAPs after 4 min of starting infusion between the three groups. At extubation, the values of hemodynamic parameters and BIS were significant between the three groups (P &lt; 0.001). While the quality of extubation improved and the sedation scores increased with the increase in the dose of dexmedetomidine, the incidence of bradycardia was more with dose of 1 μg/kg as compared to 0.75 μg/kg and 0.5 μg/kg. Conclusion: It was found that 0.75 μg/kg was the optimal dose for extubation as it facilitated smooth extubation and maintained hemodynamic stability in patients without causing undue sedation.

Effect of Probiotics on Enteral Milk Tolerance and Prevention of Necrotizing Enterocolitis in Preterm Neonates

Background: There is a dearth of studies in Iran on the efficacy of probiotics in reducing necrotizing enterocolitis (NEC), yielding contradictory results. Therefore, the present study aimed to assess the effect of probiotics on milk tolerance and the prevention of NEC in preterm neonates. Methods: This randomized triple-blind clinical trial study was conducted on all preterm neonates between 30 and 36 weeks gestation and birth weight >1250 g hospitalized in the neonatal intensive care unit (NICU) at Bentolhoda Hospital in Bojnurd, Iran. Thereafter, 76 eligible neonates were randomly assigned to two groups of oral placebo (n=38) and BB care probiotic (n=38). Subsequently, the following information was extracted based on the hospital checklist: early or late NEC (after 7 days of birth), types of NEC (grade I, II, and III), length of hospitalization, time to reach complete oral nutrition, weight at discharge, and milk tolerance. Results: In the current study, 52.6% and 47.4% of newborns in control and intervention groups were male, and no significant difference was observed between the two groups (P= 0.646). The incidence of NEC was significantly reduced among the intervention group. The feeding onset in the placebo group was significantly later, as compared to that in the intervention group. A significant difference was detected between the two groups in the length of hospital stay and weight gain during hospitalization. Conclusion: As evidenced by the obtained results, the administration of probiotics in preterm neonates might prevent NEC. Moreover, it can shorten the onset time of feeding and hospitalization duration.

Solanum xanthocarpum and Acacia catechu Willd- An Ayurvedic Soothe: A Randomized Clinical Trial

Background: Periodontitis is mainly a microbial disease which commences on accumulation of plaque. Conventional mechanical therapy comprising of scaling in addition to chemical plaque control offers greater benefits to reduce plaque and associated gingivitis. Hence, in our study we have considered the use of relatively safe herbal compounds as an adjunct to scaling. Aims &amp; Objectives of the study were, 1.To assess the antibacterial and anti-inflammatory properties of two herbal mouthrinses (Solanum xanthocarpum and Acacia catechu Willd) and 2. Compare the efficacy of herbal mouthrinses with Chlorhexidine (Gold standard). Methods: A total of 75 patients diagnosed with moderate to severe gingivitis were randomly assigned to 3 groups. The three groups were group A, Chlorhexidine mouthrinse, group B Solanum xanthocarpum mouthrinse and group C, Acacia catechu mouthrinse. This was a triple blinded study where random allocation was done by coin method. After scaling the clinical parameters namely plaque index, gingival index and sulcus bleeding index were recorded for all the three groups. Individuals were instructed to rinse with their respective mouthwash twice daily. The PI, GI and Sulcus Bleeding Index were recorded at baseline, 14th day and 21st day. Results: There was statistical significant difference in three groups in relation to GI, PI and SBI indices. Group C showed statistically significant difference in all the parameters. Conclusion: Acacia catechu and Solanum xanthocarpum were effective as antibacterial and anti-inflammatory agents. Acacia catechu showed better results than Chlorhexidine.

Effect of topical application of nanoencapsulated eugenol on dental sensitivity reduction after in‐office dental bleaching: a randomized, triple‐blind clinical trial

This randomized, split-mouth, triple-blind clinical study evaluated the effect of application of nanoencapsulated eugenol (NE) on the absolute risk and intensity of tooth sensitivity (TS) resulting from in-office bleaching. Fifty-six patients received a NE in one hemiarch and a placebo gel in the other hemiarch, determined by random sequence, before in-office bleaching. A visual analogue scale (VAS) (0-10) and a numeric rating scale (NRS) (0-4) were used to record TS during bleaching and 1 and 48 h after bleaching. The tooth color was performed from baseline to 2 weeks after bleaching with shade guides (ΔSGU) and a spectrophotometer (∆Eab , ∆E00, and WID ). The TS was assessed through the McNemar test (α = 0.05) and by the Wilcoxon signed-rank test (NRS) and paired t-test (VAS). The paired test-t was employed to compare the color changes (ΔSGU and ΔEab , ∆E00, and WID ). The significance level was 5%. No statistically significant difference was found in the absolute risk or intensity of TS between both groups (p > 0.05). A significant color change was observed in both groups (p > 0.05). Administration of the gel containing NE before the in-office dental bleaching did not reduce the TS and did not interfere in the bleaching effect. The use of desensitizing gel containing NE did not reduce in-office bleaching-induced tooth sensitivity.

Evaluation and Comparison of Human Chorionic Amniotic Membrane and Platelet-Rich Fibrin in Achieving Bone Formation and Soft Tissue Healing in Extraction Sockets Indicated for Rehabilitation with Implants: A Preliminary Study.

To evaluate and compare human chorionic amniotic membrane and platelet-rich fibrin on new bone formation and soft tissue healing in extraction sockets indicated for rehabilitation with dental implants. A prospective, triple blind clinical study was conducted. The inclusion criteria were as follows: patient with two extraction sites each in the same arch, intact buccal bone and soft tissue around the socket, and recommended rehabilitation with dental implants. Postextraction, the sockets were randomly placed with human chorionic amniotic membrane in one site and platelet-rich fibrin in the other site. After 3 months, a trephine drill was used to take a biopsy of the respective sites for soft and hard tissue samples. The outcome parameters that were assessed histologically were percentage of new bone formation and lymphocyte density. After screening 80 patients, eight participants were recruited for the study. The mean percentage of new bone formation in the human chorionic amniotic membrane group was 45.71% ± 4.82%, and for the plasma-rich fibrin group, it was 41.39% ± 6.29%, showing no statistically significant difference (z = 0.99, P = .31). In the human chorionic amniotic membrane group, six out of eight sites had mild lymphocyte density, while the plasmarich fibrin group had equal numbers of mild and moderate lymphocyte density. No statistically significant difference between the groups (Fischer test value = 0.60, P = .25) was noted. Within the limitations of the study, the results showed that there is no difference in the efficiency of human chorionic amniotic membrane compared with platelet-rich fibrin in achieving new bone formation and soft tissue healing in the extraction socket.

Stevia, sucralose and sucrose added to a maqui-Citrus beverage and their effects on glycemic response in overweight subjects: A randomized clinical trial

Background: Low-caloric sweeteners represent a good alternative to the extra boost of energy of sugar-sweetened beverages. However, their long-term effects have barely been assessed. In the present study, the influence of low-caloric sweeteners added to a maqui/Citrus beverage on the glycemic profile has been evaluated. Methods: A parallel, randomized and triple blind clinical study was performed in overweight subjects (n = 138), who consumed 330 mL/day of a beverage added with Stevia, Sucralose or Sucrose, for 60 days. Results: BMI did not change significantly with any treatment. Fasting glucose increased after the short-term consumption of Sucrose added beverage (26%), as well as with the addition of the low-caloric sweeteners, but in a lesser extent: 11% for Stevia and 20% for Sucralose. Insulin concentrations did not change significantly with any drink, which resulted in a significant increase in HOMA-IR with Sucralose (p = 0.002) and Sucrose (p = 0.001). Conclusions: The results obtained link the consumption of sucrose sweetened beverages with a disbalance in glycaemic response, and a better response with Stevia addition, although it also produces certain negative effects on glycemic control. The evidence available to date is not conclusive enough to advise the wide use of LCS.ClinicalTrials.gov NCT 04016337.