Safety and efficacy of target-controlled infusion versus intermittent bolus administration of propofol for sedation in colonoscopy: a randomized controlled trial

Abstract Background: Our objective was to compare the safety and efficacy of Target-Controlled Infusion (TCI) versus intermittent bolus of propofol for colonoscopy sedation. Methods: We conducted a randomized (1:1), single-blind, parallel-group superiority trial with fifty ASA I or II patients, both sexes, aged 18 to 65 years, Body Mass Index ≤ 30 kg.mr-2, undergoing colonoscopy, allocated to receive propofol by TCI (effect-site, 2 μg.mL-1 plus 0.5 μg.mL-1 until unconsciousness and as necessary for agitation) or intermittent bolus (1 mg.kg-1 plus 0.5 mg.kg-1 every 5 minutes or as above). The primary safety outcome was the need for airway maneuvers and the primary efficacy outcome was the need for interventions to adjust the level of sedation. Secondary outcomes included incidence of agitation, propofol dose, and time to recovery. Results: The median (IQR) number of airway maneuvers and interventions needed to adjust sedation was 0 (0-0) vs. 0 (0-0) (p = 0.239) and 1 (0-1) vs. 3 (1-4) (p < 0.001) in the TCI and control groups, respectively. Agitation was more common in the intermittent bolus group - 2 (0-2) vs. 1 (0-1), p < 0.001. The mean ± SD time to recovery was 4.9 ± 1.4 minutes in the TCI group vs. 2.3 ± 1.6 minutes in the control group (p < 0.001). The total propofol dose was higher in the TCI group (234 ± 46 μg.kg-1.min-1 vs. 195 ± 44 μg.kg-1.min-1 (p = 0.040)). Conclusions: During colonoscopy, TCI is as safe as intermittent bolus of propofol while reducing the incidence of agitation and the need for dose adjustments. However, intermittent bolus administration was associated with lower total propofol dose and earlier recovery.

Dose-response relationship between toothpaste soluble fluoride absorbed in the gastrointestinal tract and saliva fluoride secretion

Aim: This study aimed to evaluate if there is a dose-response relationship between toothpaste chemically soluble fluoride absorbed in the gastrointestinal tract and fluoride secreted by saliva, giving support to the use of saliva as surrogate for plasma fluoride. Methods: A 4-phase single blind study was conducted, in which 10 participants were subjected in each phase to one of the assigned treatment groups: group I: fresh sample of a Na2FPO3/CaCO3-based toothpaste with 1,334 µg F/g of total soluble fluoride (TSF) and groups II­IV: aged samples of this toothpaste presenting TSF concentrations of 1,128, 808, and 687 µg F/g, respectively. In all phases, the participants ingested an amount of toothpaste equivalent to 70.0 µg F/Kg body weight, as total fluoride (TF). Saliva and blood samples were collected before (baseline) and up to 180 min after toothpaste ingestion as indicator of fluoride bioavailability. F concentration in saliva and blood plasma was determined with a fluoride ion-specific electrode. The areas under the curve (AUC) of F concentration versus time (AUC = ng F/mL × min) and the peaks of fluoride concentration (Cmax) in saliva and plasma were calculated. Results: A significant correlation between mg of TSF ingested and the AUC (r=0.47; p<0.01), and Cmax (r=0.59; p<0.01) in saliva was found; for TF, the correlation was not significant (p>0.05). In addition, the correlations between plasma and saliva fluoride concentrations were statistically significant for AUC (r=0.55; p<0.01) as for Cmax (r=0.68; p<0.01). Conclusion: The findings support that saliva can be used as a systemic biomarker of bioavailable fluoride present in Na2FPO3/CaCO3-based toothpaste

Effect of intraoperative alveolar recruitment maneuver on intraoperative oxygenation and postoperative pulmonary function tests in patients undergoing robotic-assisted hysterectomy: a single-blind randomized study

Abstract Background Robotic-Assisted Hysterectomies (RAH) require Trendelenburg positioning and pneumoperitoneum, which further accentuate alteration in respiratory mechanics induced by general anesthesia. The role of Recruitment Maneuver (RM) as a lung-protective strategy during intraoperative surgical settings has not been much studied. We planned this study to evaluate the effect of RM on perioperative oxygenation and postoperative spirometry using PaO2/FiO2 and FEV1/FVC, respectively in patients undergoing RAH. Methods Sixty-six ASA I‒II female patients scheduled for elective RAH were randomized into group R (recruitment maneuver, n = 33) or group C (control, n = 33). Portable spirometry was done one day before surgery. Patients were induced with general anesthesia, and mechanical ventilation started with volume control mode, with Tidal Volume (TV) of 6-8 mL.kg−1, Respiratory Rate (RR) of 12 min, inspiratory-expiratory ratio (I: E ratio) of 1:2, FiO2 of 0.4, and Positive End-Expiratory Pressure (PEEP) of 5 cmH2O. Patients in group R received recruitment maneuvers of 30 cmH2O every 30 minutes following tracheal intubation. The primary objectives were comparison of oxygenation and ventilation between two groups intraoperatively and portable spirometry postoperatively. Postoperative pulmonary complications, like desaturation, pulmonary edema, pneumonia, were monitored. Results Patients who received RM had significantly higher PaO2 (mmHg) (203.2+-24.3 vs. 167.8+-27.3, p < 0.001) at T2 (30 min after the pneumoperitoneum). However, there was no significant difference in portable spirometry between the groups in the postoperative period (FVC, 1.40 ± 0.5 L vs. 1.32 ± 0.46 L, p= 0.55). Conclusion This study concluded that intraoperative recruitment did not prevent deterioration of postoperative spirometry values; however, it led to improved oxygenation intraoperatively.

Effects of Plasma-Lyte® and 0. 9% saline in renal function after deceased-donor kidney transplant: a randomized controlled trial

Abstract Background The influence of different crystalloid solutions infused during deceased-donor kidney transplant on the incidence of delayed graft function remains unclear. We investigated the influence of Plasma-Lyte® vs. 0.9% saline on the incidence of delayed graft function in deceased-donor kidney transplant recipients. Methods We conducted a single-blind randomized controlled trial of 104 patients aged 18 to 65 years who underwent deceased-donor kidney transplant under general anesthesia. Patients were randomly assigned to receive either Plasma-Lyte® (n = 52) or 0.9% saline (n = 52), at the same infusion volume, for intraoperative fluid replacement. The primary outcome was the occurrence of delayed graft function. Secondary outcomes included metabolic and electrolytic changes at the end of surgery. Results Two patients in the Plasma-Lyte® group and one in the 0.9% saline group died postoperatively and were not included for analysis. The incidence of delayed graft function in Plasma-Lyte® and 0.9% saline groups were 60.0% (95% Confidence Interval [95% CI 46.2-72.4]) and 74.5% (95% CI 61.1-84.4), respectively (p= 0.140). Mean (standard deviation) values of immediate postoperative pH and serum chloride levels in Plasma-Lyte® and 0.9% saline groups were 7.306 (0.071) and 7.273 (0.061) (p= 0.013), and 99.6 (4.2) mEq.L-1 and 103.3 (5.6) mEq.L-1, respectively (p< 0.001). All other postoperative metabolic and electrolyte variables were not statistically different at the immediate postoperative period (p> 0.05). Conclusion In deceased-donor kidney transplant recipients, the incidence of delayed graft function is not influenced by Plasma-Lyte® or 0.9% saline used for intraoperative fluid replacement.

Safety, tolerability and efficacy of LEGA-Kid® mechanical percussion device versus conventional chest physiotherapy in children: a randomised, single-blind controlled study

INTRODUCTION@#Chest physiotherapy (CPT) may benefit children aged below five years who suffer from lower respiratory tract infection (LRTI). However, its effects depend on the technique used. This study aimed to determine whether mechanical CPT using the LEGA-Kid® mechanical percussion device is superior to manual CPT in children with LRTI.@*METHODS@#Children aged five months to five years who were admitted and referred for CPT from January to April 2017 were randomised to either manual CPT or mechanical CPT with LEGA-Kid. Outcomes measured before intervention and two hours after intervention were respiratory rate (RR), oxygen saturation and modified Respiratory Distress Assessment Instrument (mRDAI) score.@*RESULTS@#All 30 enrolled patients showed significant reduction in post-intervention RR and mRDAI scores. There was an 8% reduction in RR for the manual CPT group (p = 0.002) and a 16.5% reduction in the mechanical CPT group (p = 0.0001), with a significantly greater reduction in the latter (p = 0.024). mRDAI scores decreased by 2.96 in the manual group (p = 0.0001) and 3.62 in the mechanical group (p = 0.002), with no significant difference between the groups. There was no significant improvement in oxygen saturation, and no adverse events were observed after CPT.@*CONCLUSION@#Children receiving both manual and mechanical CPT showed improvements in respiratory distress symptoms, with no adverse effects. A combined strategy of nebulised hypertonic saline followed by CPT for LRTI removes airway secretions and results in improvements in moderately severe respiratory distress. The LEGA-Kid mechanical CPT method is superior to manual CPT in reducing the RR.

Effects of psychological suggestion combined with rational food restriction therapy on blood glucose and lipid metabolism and mental resilience in patients with diabetes / 中华预防医学杂志

Objective: To analyze the effect of psychological suggestion combined with rational food restriction therapy on blood glucose, lipid metabolism and mental resilience in patients with diabetes. Methods: Patients with diabetes admitted to the Third Hospital of Nanchang from January 2020 to August 2020 were divided into the control group and the intervention group with randomized controlled and single blind methods. The control group was treated with routine dietary guidance and health education, and the intervention group was treated with psychological suggestion combined with rational diet therapy on the basis of the control group. Both groups were treated for 3 months. Blood glucose, lipid metabolism, mental resilience and quality of life were compared between the two groups at baseline and after 3-month intervention. Differences between groups and within groups were analyzed by t test and χ2 test. Results: 100 patients in the control group and 81 patients in the intervention group completed 3-month intervention. After 3-month intervention, the levels of glycosylated hemoglobin, fasting blood glucose, 2-hour postprandial blood glucose, low-density lipoprotein cholesterol and triglyceride in both groups were lower than those before intervention. The levels of these indicators in intervention group were lower than those in control group (P<0.05). However, the levels of high-density lipoprotein cholesterol and the scores of tenacity, self-reliance, optimism, role function, emotional function, social function, physical function and cognitive function in both groups were higher than those before intervention. These indicators in intervention group were higher than those in control group (P<0.05). Conclusion: Psychological suggestion combined with rational food restriction therapy could effectively improve the glucose and lipid metabolism, mental resilience, and quality of life among patients with diabetes.

Low-level laser acupuncture reduces postoperative pain and morphine consumption in older patients with total knee arthroplasty: A randomized placebo-controlled trial / 中西医结合学报

BACKGROUND@#Patients commonly develop postoperative pain after total knee arthroplasty (TKA). Acupuncture-related techniques and low-level laser therapy could be beneficial for pain management for older individuals.@*OBJECTIVE@#To examine the effect of low-level laser acupuncture (LA) in reducing postoperative pain, pain-related interference in daily life, morphine consumption, and morphine-related side effects in older patients with knee osteoarthritis who underwent TKA.@*DESIGN, SETTING, PARTICIPANTS AND INTERVENTION@#A single-blind randomized placebo-controlled trial was conducted. Patients (N = 82) were recruited and randomly assigned via a computer-generated list to the LA group or a placebo group. The LA group received low-level laser therapy at Sanyinjiao (SP6), Taixi (KI3), Kunlun (BL60), Fengshi (GB31), Futu (ST32) and Neiguan (PC6) after TKA, while the placebo acupuncture group received the same treatment procedure without laser energy output.@*MAIN OUTCOME MEASURES@#The primary outcome was postoperative pain intensity, and it was measured at baseline and hours 2, 6, 10, 24, 48 and 72 after TKA. The secondary outcomes, including relative pain, postoperative pain-related interference in daily life and morphine consumption, were measured at hours 24, 48 and 72 after TKA.@*RESULTS@#Generalized estimating equations revealed significant between-group differences in pain intensity (P = 0.01), and trend differences in pain intensity for the LA group starting at hours 10 to 72 (P < 0.05) and morphine consumption at hours 48 and 72 (P < 0.05). The changes in pain-related interference in daily life were significant (P < 0.05) at 72 h, with the exception of the parameters for worst pain, mood, and sleep. Nausea and vomiting side effects from morphine had significant between-group differences at hours 10 and 24 (P < 0.05).@*CONCLUSION@#Low-level LA gradually reduced older patients' postoperative pain intensity and morphine consumption within the first 72 h after their TKA for osteoarthritis. Low-level LA may have benefits as an adjuvant pain management technique for clinical care.@*TRIAL REGISTRATION@#ClinicalTrials.gov registration number NCT03995446.

Avaliação clínica de restaurações Classe V em cavidades tratadas com o laser de Er: YAG associado ao uso de sistemas adesivos autocondicionantes / Clinical evaluation of Class V restorations in cavities treated with Er: YAG laser associated with the use of self-etching adhesive systems

O objetivo deste estudo clínico, controlado, randomizado, cego e prospectivo foi de avaliar a efetividade clínica de restaurações em lesões não cariosas (cavidades Classe V) realizadas em superfícies dentais pré-tratadas ou não com laser de Er:YAG e utilizando dois sistemas adesivos autocondicionantes. Este estudo foi realizado com um total de 91 lesões e divididas em 4 grupos (n = 23) :G1(FL): Sem pré-tratamento e utilizando o adesiso FL-Bond II/Shofu; G2 (CF): sem pré-tratamento e utilizando o adesivo Clearfil SE Bond 2/Kuraray Noritake; G3 (Laser + FL): pré-tratamento associado ao uso do FL-Bond II/Shofu e G4 (Laser + CF): pré-tratamento associado ao uso do Clearfil SE Bond 2/Kuraray Noritake Os dentes avaliados foram os pré-molares de ambas as arcadas. A avaliação foi feita imediatamente após o tratamento e ao longo do tempo, em 3, 6 e 12 meses após a finalização da restauração. Para a avaliação da sensibilidade foi considerado a EVA (Escala Visual Analógica) e para a qualidade da restauração o método do USPHS modificado, considerando a avaliação de perda de retenção, integridade marginal, pigmentação marginal, presença de lesão de cárie em margem de restauração, vitalidade pulpar e sensibilidade pós-operatória. Os dados foram registrados em tabelas de frequência, e os escores transformados em postos para a aplicação do teste ANOVA. A significância estatística foi considerada para valores de p<0,05. Para os resultados da avaliação de sensibilidade houve uma diferença estatística significante da sensibilidade ao longo do tempo (p<0,001), sendo que essa diferença se deu a partir da avaliação T1 (48 horas) em todos os grupos. Em relação aos critérios avaliados no USPHS, foram encontrados variações estatísticas em alguns tópicos: Pigmentação marginal - G1 (FL) (p=0,041) e G2 ( Laser + FL) (p=0,009) e Integridade marginal G1(FL)( p=0,036). Os demais grupos e critérios não apresentaram variações estatísticas significantes.Pré-tratamentos com laser Er:YAG podem ser uma alternativa viável em restaurações adesivas do tipo classe V; no entanto, nenhum efeito sinérgico de ambos os tratamentos combinados foi observado.

The objective of this clinical, controlled, randomized, blinded and prospective study was to evaluate the clinical effectiveness of restorations in non-carious lesions (Class V cavities) performed on dental surfaces pre-treated or not with Er:YAG laser and using two adhesive systems self-conditioning. This study was carried out with a total of 91 lesions and divided into 4 groups (n = 23) :G1(FL): No pre-treatment and using the FL-Bond II/Shofu adhesive; G2 (CF): without pre-treatment and using Clearfil SE Bond 2/Kuraray Noritake adhesive; G3 (Laser + FL): pre-treatment associated with the use of FL-Bond II/Shofu and G4 (Laser + CF): pre-treatment associated with the use of Clearfil SE Bond 2/Kuraray Noritake The teeth evaluated were the premolars of both arcades. Assessment was performed immediately after treatment and over time, at 3, 6, and 12 months after completion of the restoration. The VAS (Visual Analogue Scale) was used for the sensitivity assessment and the modified USPHS method for the quality of the restoration, considering the assessment of loss of retention, marginal integrity, marginal pigmentation, presence of caries in the restoration margin. , pulp vitality and postoperative sensitivity. Data were recorded in frequency tables, and the scores were transformed into ranks for the application of the ANOVA test. Statistical significance was considered for values of p<0.05. For the results of the sensitivity evaluation, there was a statistically significant difference in sensitivity over time (p<0.001), and this difference occurred from the T1 evaluation (48 hours) in all groups. Regarding the criteria evaluated at the USPHS, statistical variations were found in some topics: Marginal pigmentation - G1 (FL) (p=0.041) and G2 (Laser + FL) (p=0.009) and Marginal integrity - G1(FL)( p =0.036). The other groups and criteria did not present significant statistical variations. Pretreatments with Er:YAG laser can be a viable alternative in class V adhesive restorations; however, no synergistic effect of both treatments combined was observed.

Efeitos Terapêuticos da Tripla Antiagregação Plaquetária em Pacientes Femininas Idosas com Diabetes e Infarto Agudo do Miocárdio / Therapeutic Effects of Triple Antiplatelet Therapy in Elderly Female Patients with Diabetes and Acute Myocardial Infarction

Resumo Fundamento A dupla antiagregação plaquetária (DAP) é o tratamento fundamental do infarto agudo do miocárdio (IAM). Objetivo O presente estudo visou investigar a eficácia e a segurança da tripla antiagregação plaquetária (TAP) em pacientes femininas idosas com diabetes e infarto agudo do miocárdio com supradesnível do segmento ST (IAMCSST), que foram submetidas à intervenção coronária percutânea ICP. Métodos Trata-se se de um estudo randomizado e mono-cego. O grupo controle A (97 pacientes idosos do sexo masculino com diabetes e STEMI, cujos escores CRUSADE foram < 30) recebeu aspirina, ticagrelor e tirofibana. Um total de 162 pacientes femininas idosas com diabetes e IAMCSST foram divididas aleatoriamente em dois grupos de acordo com o escore CRUSADE. O grupo B (69 pacientes com escore CRUSADE > 31) recebeu aspirina e ticagrelor. O grupo C (93 pacientes com escore CRUSADE < 30) recebeu aspirina, ticagrelor e tirofibana. Valores de p < 0,05 foram considerados estatisticamente significativos. Resultados Após a PCI, o fluxo sanguíneo grau 3 Thrombolysis in Myocardial Infarction (TIMI) e a perfusão miocárdica TIMI grau 3 foram significativamente menos prevalentes no grupo B, em comparação com o grupo A (p < 0,05). Quando comparada aos grupos A e C, a incidência de complicações adversas maiores foi significativamente maior no grupo B (p < 0,05). Conclusão A TAP pode efetivamente reduzir a incidência de complicações maiores em pacientes idosas com diabetes e IAMCSST. No entanto, atenção cuidadosa deve ser dada à hemorragia em pacientes que recebem TAP. (Arq Bras Cardiol. 2020; [online].ahead print, PP.0-0)

Abstract Background Dual antiplatelet therapy (DAPT) is the cornerstone treatment of acute myocardial infarction (AMI). Objective The present study aimed to investigate the efficacy and safety of triple antiplatelet therapy (TAPT) in elderly female patients with diabetes and ST segment elevation myocardial infarction (STEMI), who had undergone percutaneous coronary intervention (PCI). Methods We designed a randomized, single-blind study. Control group A (97 elderly male patients with diabetes and STEMI, whose CRUSADE scores were < 30) received aspirin, ticagrelor, and tirofiban. A total of 162 elderly female patients with diabetes and STEMI were randomly divided into two groups according to CRUSADE score. Group B (69 patients with CRUSADE score > 31) received aspirin and ticagrelor. Group C (93 patients with CRUSADE score < 30) received aspirin, ticagrelor and tirofiban. P values < 0.05 were considered statistically significant. Results Compared to the findings in group A, post-PCI Thrombolysis in Myocardial Infarction (TIMI) grade 3 blood flow and TIMI myocardial perfusion grade 3 were significantly less prevalent in group B (p < 0.05). When compared to groups A and C, the incidence of major adverse complications was significantly higher in group B (p < 0.05). Conclusion TAPT could effectively reduce the incidence of major complications in elderly female patients with diabetes and STEMI. However, close attention should be paid to hemorrhage in patients receiving TAPT. (Arq Bras Cardiol. 2020; [online].ahead print, PP.0-0)

Brush up: an innovative technological aid for parents to keep a check of their childrens oral hygiene behaviour / Brush up: uma ajuda tecnológica inovadora para os pais controlarem o comportamento de higiene bucal de seus filhos

ABSTRACT Objective: To investigate the impact of "Brush Up" - a mobile application, on oral hygiene behaviours of 4-6-year-old children in Bangalore city. Methods: In this experimental study, 247 children aged 4-6, were randomly divided into three groups. Considering "Brush Up" is a mobile application, parents of the children in Group 1 (n=82) downloaded the application on their smartphones. Children in Group 2 (n=83) and Group 3 (n=82) received tooth brushing instructions by an educative video and manual demonstration, respectively. Effectiveness of tooth brushing was assessed with plaque scores, which were recorded for all the groups at baseline and one month using Visible Biofilm Index. Results: Wilcoxon signed rank test showed a significant improvement in the tooth brushing behaviour for the Brush Up group, which was indicated by a lower plaque score after a follow-up of one month. Kruskal-Wallis test followed by post-hoc test showed that the mean ranks of plaque scores of Brush Up group are consistently lower than those of video demonstration group and manual demonstration group. Conclusions: The lower plaque score in subsequent follow-up in Brush Up group suggests that using a smart system can enhance learning a correct tooth brushing method in young children and can also help in implementing the required reinforcement and motivation to brush and aid in better plaque control.

RESUMO Objetivo: Investigar o impacto do "Brush Up", um aplicativo móvel, sobre comportamentos de higiene bucal de crianças de 4 a 6 anos na cidade de Bangalore, na Índia. Métodos: Neste estudo experimental, 247 crianças de 4 a 6 anos foram divididas aleatoriamente em 3 grupos. Como "Brush Up" é um aplicativo móvel, os pais das crianças do Grupo 1 (n=82) baixaram o aplicativo em seus smartphones. As crianças do grupo 2 (n=83) e do grupo 3 (n=82) receberam instruções sobre escovação por meio de vídeo educativo e demonstração manual, respectivamente. A efetividade da escovação foi avaliada por meio de escores de placa bacteriana, registrados para todos os grupos antes da intervenção e um mês depois. Resultados: O teste de Wilcoxon sinalizou uma melhora significativa na escovação para o grupo "Brush Up", com uma pontuação mais baixa na placa bacteriana após um mês de acompanhamento. O teste de Kruskal-Wallis, seguido do teste post hoc, mostrou que as classificações médias das pontuações do grupo "Brush Up" foram consistentemente mais baixas do que as do grupo com demonstração em vídeo e demonstração manual. Conclusões: Os resultados obtidos no grupo "Brush Up" sugerem que o uso de um sistema inteligente pode melhorar o aprendizado de um método correto de escovação em crianças pequenas e ajudar na implementação do reforço e motivação necessários para escovar e controlar melhor a placa bacteriana.

Efficacy of Higher Gauged Needles or Topical Pre-Cooling for Pain Reduction during Local Anesthesia Injection: A Split-Mouth Randomized Trial

ABSTRACT Objective: To evaluate the efficacy of pre-cooling and the use of higher gauged needles in reducing pain during local anesthetic infiltration. Material and Methods: We conducted a split-mouth randomized controlled trial among 70 patients who require bilateral maxillary local anesthetic (LA) injections for dental treatment. After applying the topical anesthetic, each participant received four local anesthetic injections, two on buccal and two palatal sides. At each visit, the participants received one buccal and one palatal infiltration based on the randomization. On the buccal aspect, participants received LA with a 26G needle injection on one side (control) and a 31G needle (test) on the contralateral side. On the Palatal aspect, participants either received LA with a 31G needle on one side (control). In contrast, the opposite side was preceded by topical ice application (iced cotton swab) before LA with a 31G needle (test). Both the visits were spaced with a gap of 7-10 days based on the participants' feasibility. Participants were asked to rate the pain on a visual analog scale independently for buccal and palatal LA injections. Results: On the Buccal aspect, the mean pain scores were 2.74 ± 1.26 and 2.11 ± 1.26 for control and test groups, respectively (p=0.002). On the Palatal aspect, the mean pain scores were 4.14 ± 1.49 and 4.3 ± 1.80 for control and test groups, respectively (p=0.295). Conclusion: Significant lower pain scores were reported with higher gauge needles (31G) when compared to traditional (26G) needles on the buccal aspect. No significant difference was seen with pre-cooling the injection site on the palatal aspect when used with higher gauged needles (31G) (AU).

Influence of Isolation Technique on the Survival of Resin-Modified Glass-Ionomer Restorations in Primary Molars: A 9-Months Randomized Controlled Trial

ABSTRACT Objective: To compare the survival of occlusal and occlusal-proximal restorations performed with resin-modified glass-ionomer cement (RMGIC) in deciduous molars using rubber dam and cotton rolls isolation. Material and Methods: Ninety-two patients were included and 200 deciduous molars with cavitated occlusal or occlusoproximal dentin caries lesions were randomized into two groups: cotton rolls (n = 100) and rubber dam (n = 100) and RMGIC restorations were placed. At baseline and in the follow-up visit, presence, severity and activity of caries lesions were registered. Two independent, blinded examiners evaluated the treated teeth clinically using the USPHS criteria and radiographically after 9 months. Descriptive analysis, survival curve (log-rank test) and Cox regression were performed to assess risk factors related to failure. Results: Out of the 179 teeth (92 cotton rolls group and 87 rubber dam group) evaluated at 9-month follow-up period. No lesion progression was observed radiographically. The overall treatment success rate was 85.47% (83.47% for cotton rolls and 87.35 rubber dam group). No significant difference between isolation methods was observed in the log-rank test (p = 0.16). Cox regression showed no risk factors related to failure. Conclusion: No difference was found in the survival of occlusal and occlusal-proximal restorations performed with RMGIC in deciduous molars using a rubber dam and cotton rolls isolation after a 9-month follow-up period.

Effectiveness of three different types of educational methods on implementation of proper oral hygiene behaviour prior to orthodontic treatment

ABSTRACT Objective: The aim of this study was to compare three teaching methods' time and personnel requirements, and their effects on plaque and gingival indices. Methods: This study was a single-blind randomized controlled trial on fixed orthodontic appliance candidates (n = 90), assigned into a control group (n = 30) and two different study groups (n = 30 each). The control group received standard printed educational material and was assisted with verbal information. The study groups either received video-assisted or hands-on training about fixed orthodontic appliance and oral hygiene. The time requirements for all three educational interventions was recorded during the initial visit. The adequacy of oral hygiene was documented through plaque and gingival indices during the initial visit and eighth week of the treatment. The continuous variables were analyzed using 1-way ANOVA. Tukey HSD and Student t-tests were used for post-hoc comparisons (α?#8197;= 0.05). Also, a chi-square test was used for the analysis of categorical variables. Results: Standard education failed to maintain the plaque and gingival indices at the eighth week of the treatment. Although both video-assisted and hands-on training took a considerable amount of time, they served well in preserving both of the indices at the eighth week. The longer the educational intervention was, the better the preservation of the plaque and gingival indices. Conclusion: Educational intervention, either with video-assisted or hands-on programs, provided better results in oral hygiene depending on the time and personnel constraints of the orthodontist.

RESUMO Objetivo: O objetivo do presente estudo foi comparar a duração e os pré-requisitos de equipe de três métodos de orientação ao paciente, e seus efeitos sobre os índices de placa e de sangramento gengival. Métodos: Esse foi um estudo controlado aleatório cego em candidatos (n=90) a tratamento ortodôntico fixo, que foram divididos em um grupo controle (n=30) e dois grupos de estudo (n= 30 cada). O grupo controle recebeu material educacional impresso e foi orientado com informações verbais. Os grupos de estudo receberam treinamento em formato de vídeo ou treinamento hands-on sobre o tratamento com Ortodontia fixa e higiene bucal. O tempo necessário para cada um dos três tipos de treinamento foi registrado durante a visita inicial. A qualidade da higiene bucal foi avaliada por meio dos índices de placa e de sangramento gengival durante a visita inicial e na oitava semana de tratamento. As variáveis contínuas foram analisadas utilizando-se one-way ANOVA. Os testes HSD de Tukey e t de Student foram utilizados para comparações post-hoc (α?#8197;= 0,05), e o teste qui-quadrado foi utilizado para análise das variáveis categóricas. Resultados: O método de ensino convencional fracassou em manter os índices de placa e de sangramento gengival até a oitava semana de tratamento. Apesar de tanto o método de treinamento com vídeos e de treinamento hands-on demandarem um tempo considerável, eles conseguiram manter ambos os índices até a oitava semana. Quanto mais longa a orientação realizada, melhor foi a manutenção dos índices de placa e de sangramento gengival. Conclusão: Tanto o método de treinamento com vídeo quanto no formato hands-on obtiveram melhores resultados de higiene bucal, mas dependem do tempo e das limitações de equipe de cada ortodontista.

Treatment of knee osteoarthritis with a new formulation of a fixed-dose combination of glucosamine sulfate and bovine chondroitin: a multicenter, randomized, single-blind, non-inferiority clinical trial

Abstract Objectives: To compare the efficacy and safety of a new formulation of a fixed dose combination of glucosamine sulfate (GS; 1500 mg) and bovine chondroitin sulfate (CS; 1200 mg) versus the reference product (RP) in patients with knee osteoarthritis (OA). Methods: In this multicenter, randomized, single-blind trial, 627 patients with knee osteoarthritis (OA)—Kellgren-Lawrence grades 2 or 3 and mean score ≥ 40 mm in the WOMAC pain subscale—were randomized to receive GS/ CS or the RP for 24 weeks. The primary efficacy endpoint was the absolute change in WOMAC pain subscale score. The secondary endpoints included the following: WOMAC total and subscale scores, overall assessment of the disease by the patient and the investigator, SF-12 score, OMERACT-OARSI response rate to the treatment, and rescue medication use. Results: Mean reductions of WOMAC pain score were - 35.1 (sd = 23.2) mm in the GS/CS group and - 36.5 (sd = 24.9) mm in the RP group. The difference between the adjusted means of both treatments confirmed the noninferiority of GS/CS versus the RP. Improvement was observed in pain, stiffness, physical function and total WOMAC score, as well as in overall OA assessment by the patient and the investigator for both groups. No improvement was observed in SF-12. The rate of OMERACT-OARSI responders was 89.4% in GS/CS group and 87.9% in the RP group. Headache and changes in glucose tolerance were the most frequent treatment-related adverse events. Conclusions: The new formulation of a fixed-dose combination of glucosamine sulfate and bovine chondroitin sulfate was non-inferior to the RP in symptomatic treatment of knee OA, with a high responder rate and good tolerability profile. Trial registration: ClinicalTrials.gov; Registration number NCT02830919; Date of registration: July 13, 2016; First randomization date: December 05, 2016).(AU)

Efficacy of two soft-bristle toothbrushes in plaque removal. A randomized controlled trial / Eficácia de duas escovas de cerdas macias na remoção de Placa. Um ensaio clínico randomizado

ABSTRACT The aim of the present examiner-blind randomized controlled clinical study was to compare the efficacy two soft-bristle toothbrushes in terms of plaque removal. Seventy volunteers were randomly allocated to Group A (tapered-tip toothbrush) or Group B (end-rounded toothbrush). At baseline appointment (Day 0), volunteers underwent plaque examination using the Improved Plaque Identification Index. Under supervision, they brushed their teeth for 1 minute with their assigned toothbrushes and the plaque examination was repeated. Volunteers continued the oral hygiene regimen (assigned toothbrush and a regular dentifrice provided by the researchers) for 7 days. The experimental procedures of Day 0 were then repeated. Separate statistical analyses were performed for mean percent reduction of plaque in the whole-mouth, interproximal and gumline scores at both times, usingMann-Whitney test, p<0.05. After a single toothbrushing, on Day 0, mean percent plaque was significantly reduced in both groups (p<0.05), with statistically greater reductions of whole-mouth (21.39±12.44 vs. 11.40±11.17), gumline (6.32±7.37 vs. 2.89±4.57) and interproximal (10.82±10.49 vs. 5.21±7.68) for Group A as compared to Group B. However, on day 7, no significant difference was observed between groups for whole-mouth (29.94±20.91 vs. 26.58±18.64), gymline (14.04±18.82 vs. 13.78±17.63) and interproximal surfaces (26.41±22.77vs. 23.12±20.98) (p>0.05). In conclusion, on Day 0, Group A presented higher efficacy in supragingival plaque removal than Group B, as reflected by whole-mouth, gumline and interproximal plaque scores.

RESUMO O objetivo desse ensaio clínico, examinador-cego, randomizado e controle foi de comparadas a eficácia de duas escovas de cerdas macias em relagäo ao controle de placa. Setenta vo-luntários foram randomicamente alocados para Grupo A (es-cova com ponta cónica) ou Grupo B (escova com ponta arredondada). Na consulta inicial (dia 0), voluntarios receberam exame de placa utilizando o Índice de identificagäo de placa melhorado. Sob supervisäo, eles escovaram seus dentes por 1 minuto com as escovas designadas e o exame de placa foi repetido. Voluntarios continuaram seu regime de higiene oral (escova dental alocada e dentifrício comum fornecidos pelos pesquisadores) durante 7 dias. Os procedimentos da consulta inicial foram novamente repetidos. Análises estatísticas distintas foram realizadas para percentual de redugäo média de placa para os escores de boca toda, interproximal e linha gengi-val em ambos os momentos, utilizando teste de Mann-Whitney, p<0,05. Após único uso da escova, no dia 0, o percentual de redugäo média de placa foi significativamente reduzido em ambos os grupos (p<0,05), com reduções significativas para boca toda (21,39±12,44 vs. 11,40±11,17), linha gengival (6,32±7,37 vs. 2,89±4,57) e interproximal (10,82±10,49 vs. 5,21±7,68) no Grupo A quando comparada com o Grupo B. Entretanto, no dia 7, nenhuma diferenga significativa foi observada entre os grupos para boca toda (29,94±20,91 vs. 26,58±18,64), linha gengival (14,04±18,82 vs. 13,78±17,63) e interproximal (26,41±22,77 vs. 23,12±20,98) (p>0,05). Em conclusäo, no dia 0, a escova do Grupo A apresentou eficácia superior na remo-gäo de placa suprageng ival quando comparada com a escova do Grupo B, como demonstrado nos escores de placa de boca toda, linha gengival e interproximal.

Comparison of post-operative nausea and vomiting with intravenous versus inhalational anesthesia in laparotomic abdominal surgery: a randomized clinical trial / Comparação entre anestesia intravenosa e inalatória na náusea e vômito pós-operatórios em laparotomia: estudo clínico randomizado

Abstract Background: Postoperative Nausea and Vomiting (PONV) is a multifactorial surgical complication with an unclear underlying cause. Anesthetic methods, patients' characteristics and the type of surgery are considered as factors affecting PONV. This study was designed to compare the effect of inhalational and intravenous anesthesia in abdominal surgery on the incidence and severity of PONV. Methods: A single-blinded prospective randomized clinical trial on 105 patients aged 18 − 65 years was carried out. Patients were divided into two groups of Total Intravenous Anesthesia (TIVA) and inhalational anesthesia. The incidence and the severity of PONV were examined at 0, 2, 6, 12 and 24 hours after the surgery. The use of a rescue antiemetic was also evaluated. Results: 50.9% of the patients in the inhalation group and 17.3% of the patients in the intravenous group developed PONV (p < 0.001). The incidence of vomiting was reported in 11.3% of the inhalational group and 3.8% of the TIVA group (p = 0.15). 24.5% of patients in the inhalation group and 9.6% of patients in the intravenous group needed an antiemetic medication (p = 0.043). Conclusion: The incidence of postoperative nausea and vomiting and the need for administration of an antiemetic rescue drug and the severity of nausea in patients were significantly lower in the TIVA group.

Resumo Justificativa: Náusea e Vômito no Pós-Operatório (NVPO) é uma complicação multifatorial com etiologia não esclarecida. A técnica anestésica, as características dos pacientes e o tipo de cirurgia são considerados fatores que afetam a NVPO. O presente estudo foi desenhado para comparar o efeito da anestesia inalatória com anestesia intravenosa na incidência e gravidade de NVPO na cirurgia abdominal. Método: Foi realizado estudo clínico mono-cego prospectivo randomizado com 105 pacientes com idades de 18 − 65 anos. Os pacientes foram divididos em dois grupos, Anestesia Total Intravenosa (TIVA) e anestesia inalatória. A incidência e gravidade de NVPO foram avaliadas em cinco momentos: 0, 2, 6, 12 e 24 horas pós-cirurgia. O uso de antiemético de resgate também foi avaliado. Resultados: NVPO ocorreu em 50,9% dos pacientes no grupo inalatória e 17,3% dos pacientes no grupo TIVA (p< 0,001). A incidência de vômitos relatados foi 11,3% no grupo Inalatória e 3,8% no grupo TIVA (p = 0,15). Necessitaram de medicação antiemética 24,5% dos pacientes no grupo Inalatória e 9,6% dos pacientes no grupo TIVA (p = 0.043). Conclusão: A incidência de náusea e vômito no pós-operatório, a necessidade de administração de droga antiemética de resgate e a gravidade da náusea foram significantemente mais baixas no grupo TIVA.

Efecto sobre la saciedad y glucemia postprandial de un yogur hiperproteico vs otro normoproteico en mujeres adultas / Effect on post-prandial saciety and glucemia of a hyperproteic vs another normoproteic yogurt in adult women

Introducción: las proteínas presentes en los alimentos juegan un rol saciógeno y pueden actuar sobre la respuesta insulínica y la glucemia plasmática postprandial. Objetivos: evaluar saciedad y glucemia postprandial luego del consumo de yogur hiperproteico vs normoproteico en mujeres adultas aparentemente sanas, residentes de la Ciudad Autóno-ma Buenos Aires y el Gran Buenos Aires. Materiales y métodos: ensayo clínico cruzado simple ciego, sobre una muestra de 79 mujeres adultas (25-65 años), no diabéticas ni intolerantes a la glucosa. Se comparó saciedad, impacto glucémico y agradabilidad de dos yogures ofrecidos como merienda, con diferente aporte proteico, controlados en grasas y carbohidratos, con relación proteínas/carbohidratos: 0,56 en yogur hiperproteico y 0,33 en normoproteico. Se va-loró estado nutricional mediante índice de masa corporal (bajo peso <18,5 kg/m2, normopeso: 18,5 a 24,9 kg/m2, sobrepeso u obesidad: ≥25 kg/m2) y riesgo cardiometabólico mediante índice cintura/talla (≥0,50). Estadística mediante software SPSS 22.0, aplicando prueba de Wilcoxon y chi cuadrado o prueba exacta de Fisher, con nivel de significación estadística <0,05. Resultados: edad promedio: 34,4±11 años. El 65,8% con ade-cuado estado nutricional según IMC y 26,6% con riesgo cardio-metabólico aumentado, ambas variables asociadas en forma di-recta con la edad (p=0,0000 y p=0,001 respectivamente).El yogur hiperproteico fue más aceptado (p=0,03) con mejor res-puesta sobre saciedad post ingesta que el yogur normoproteico, a la hora y a las dos horas de ingerido (p=0,001 y p=0,000 res-pectivamente). A su vez, impactó significativamente más sobre la respuesta glucémica postprandial sólo a los 30 minutos de consu-mido (p=0,02), pero no a los 60 minutos (p=0,59). Conclusiones: el yogur hiperproteico alcanzó mayor agra-dabilidad y otorgó, a igual porción estándar, mayor saciedad postprandial que un yogur similar normoproteico, sin afectar la glucemia postprandial.

Pulse pressure variation guided fluid therapy during kidney transplantation: a randomized controlled trial / Reposição de volume orientada pela variação da pressão de pulso durante transplante renal: estudo randomizado controlado

Abstract Purpose: Kidney transplantation is the gold-standard treatment for end stage renal disease. Although different hemodynamic variables, like central venous pressure and mean arterial pressure, have been used to guide volume replacement during surgery, the best strategy still ought to be determined. Respiratory arterial Pulse Pressure Variation (PPV) is recognized to be a good predictor of fluid responsiveness for perioperative hemodynamic optimization in operating room settings. The aim of this study was to investigate whether a PPV guided fluid management strategy is better than a liberal fluid strategy during kidney transplantation surgeries. Identification of differences in urine output in the first postoperative hour was the main objective of this study. Methods: We conducted a prospective, single blind, randomized controlled trial. We enrolled 40 patients who underwent kidney transplantation from deceased donors. Patients randomized in the "PPV" group received fluids whenever PPV was higher than 12%, patients in the "free fluid" group received fluids following our institutional standard care protocol for kidney transplantations (10 mL.kg-1. h-1). Results: Urinary output was similar at every time-point between the two groups, urea was statistically different from the third postoperative day with a peak at the fourth postoperative day and creatinine showed a similar trend, being statistically different from the second postoperative day. Urea, creatinine and urine output were not different at the hospital discharge. Conclusion: PPV guided fluid therapy during kidney transplantation significantly improves urea and creatinine levels in the first week after kidney transplantation surgery.

Resumo Objetivo: Transplante renal é o tratamento padrão-ouro na doença renal em estágio terminal. Embora diferentes variáveis hemodinâmicas, tais como pressão venosa central e pressão arterial média, têm sido usadas para orientar a estratégia de reposição volêmica durante a cirurgia, a melhor estratégia ainda não foi determinada. A Variação da Pressão de Pulso (VPP) durante o ciclo respiratório é reconhecida como um bom preditor da resposta à infusão de volume para otimização hemodinâmica perioperatória no centro cirúrgico. O objetivo do estudo foi estudar se a estratégia de reposição de volume orientada por VPP é melhor do que a estratégia liberal de reposição de volume durante cirurgia de transplante renal. O principal objetivo do estudo foi identificar diferença no débito urinário na primeira hora do pós-operatório. Método: Realizamos estudo prospectivo, unicego, randomizado, controlado. Incluímos 40 pacientes submetidos a transplante renal de doador cadáver. Pacientes randomizados para o Grupo VPP receberam volume quando a VPP estava acima de 12%, e os pacientes no Grupo Reposição Liberal receberam volume de acordo com o nosso protocolo institucional padrão de assistência para transplante renal (10 mL.kg-1.h-1). Resultados: O débito urinário foi semelhante em todos os tempos nos dois grupos, a ureia foi estatisticamente diferente a partir do terceiro dia do pós-operatório com pico no quarto dia do pós-operatório e a creatinina apresentou tendência semelhante, tornando-se estatisticamente diferente a partir do segundo dia do pós-operatório. Ureia, creatinina e débito urinário não estavam diferentes na alta hospitalar. Conclusões: A terapia orientada por VPP durante transplante renal melhorou de forma significativa os níveis de ureia e creatinina na primeira semana pós-transplante renal.

Comparison of two supraglottic airway devices on postoperative sore throat in children: a prospective randomized controlled trial / Comparação entre dois dispositivos supraglóticos de vias aéreas na dor de garganta pós-operatória em crianças: estudo controlado prospectivo randomizado

Abstract Background and objective: Sore throat is well recognized complaint after receiving general anesthesia. This study is conducted to compare the severity and frequency of postoperative sore throat in children undergoing elective surgery, following the use of Ambu laryngeal mask airway or I-gel®, who are able to self-report postoperative sore throat. Method: Seventy children, 6 to 16 years-old, undergoing elective surgery randomly allocated to either Ambu laryngeal mask (Ambu Group) or I-gel® (I-gel Group). After the procedure, patients were interviewed in the recovery room immediately, after one hour, 6 and 24 hours postoperatively by an independent observer blinded to the device used intra-operatively. Results: On arrival in the recovery room 17.1% (n = 6) of children of the Ambu Group complained of postoperative sore throat, against 5.7% in I-gel Group (n = 2). After one hour, the results were similar. After 6 hours, postoperative sore throat was found in 8.6% (n = 3) of the children in Ambu group vs. 2.9% (n = 1) in I-gel Group. After 24 hours, 2.9% (n = 1) of the children in Ambu Group complained of postoperative sore throat compared to none in I-gel Group. There was no significant difference found in the incidence of postoperative sore throat in both devices on arrival (p = 0.28); after 1 hour (p = 0.28); after 6 hours (p = 0.30); and after 24 hours (p = 0.31). The duration of the insertion of Ambu laryngeal mask was shorter and it was easier to insert than I-gel® (p = 0.029). Oropharyngeal seal pressure of I-gel® was higher than that of Ambu laryngeal mask (p = 0.001). Conclusion: The severity and frequency of postoperative sore throat in children is not statistically significant in the I-gel Group compared to Ambu Group.

Resumo Justificativa e objetivo: Dor de garganta é uma queixa bem conhecida após anestesia geral. O presente estudo comparou a gravidade e a frequência da queixa de dor de garganta pós-operatória associada ao uso de máscara laríngea Ambu ou máscara laríngea I-gel® durante cirurgia eletiva, em crianças capazes de autoreferir a queixa no pós-operatória. Método: Setenta crianças, de 6 a 16 anos submetidas à cirurgia eletiva foram alocadas aleatoriamente para o emprego da máscara laríngea Ambu (Grupo Ambu) ou para o emprego da máscara laríngea I-gel® (Grupo I-gel). Após o procedimento, os pacientes foram entrevistados imediatamente após admissão na sala de recuperação pós-anestésica-SRPA, uma hora, 6 e 24 horas após a cirurgia por um observador independente e cego ao dispositivo de vias aéreas utilizado no intraoperatório. Resultados: Na admissão à SRPA, 17,1% das crianças no Grupo Ambu (n = 6) se queixaram de dor de garganta pós-operatória, contra 5,7% no Grupo I-gel (n = 2). Após uma hora, os resultados foram similares. Após 6 horas, houve dor de garganta pós-operatória em 8,6% (n = 3) das crianças no Grupo Ambu vs. 2,9% (n = 1) no Grupo I-gel. Após 24 horas, 2,9% (n = 1) das crianças no Grupo Ambu versus nenhuma criança no Grupo I-gel. Não houve diferença significante na incidência de dor de garganta pós-operatória nos dois dispositivos na admissão na SRPA (p = 0,28); após 1 hora (p = 0,28); após 6 horas (p = 0,30); e após 24 horas (p = 0,31). A duração da inserção foi menor no grupo da máscara laríngea Ambu, e a I-gel® foi mais fácil de inserir (p = 0,029). A pressão de selagem orofaríngea do I-gel® foi maior do que a da máscara laríngea Ambu (p = 0,001). Conclusão: A gravidade e a frequência da dor de garganta pós-operatória em crianças não foram estatisticamente significantes no grupo com máscara laríngea I-gel® em comparação ao grupo com máscara laríngea Ambu.