908 resultados para Ensaio clínico randomizado


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O objetivo deste trabalho foi avaliar se, após 18 meses de acompanhamento, a aplicação semestral de verniz fluoretado em pré-escolares reduz a incidência de cárie na dentição decídua. Os possíveis efeitos adversos e a aceitabilidade da intervenção também foram investigados. Desenho do estudo: ensaio clínico controlado, randomizado, duplo-cego, com uso de placebo. Ingressaram no estudo 200 crianças na faixa etária de 12 a 48 meses, recrutadas em uma unidade da rede pública de saúde. Cem crianças foram alocadas no grupo teste (verniz fluoretado Duraphat, Colgate Oral Pharmaceuticals, New York, NY, USA) e 100 no grupo controle (verniz placebo, Colgate Oral Pharmaceuticals, New York, NY, USA). Os exames clínicos, seguidos das aplicações semestrais de verniz nos grupos teste e controle, foram realizados por duas odontopediatras treinadas (Kappa=0,85) que utilizaram o International Caries Detection and Assessment System II (ICDAS II) para registrar o índice ceo-s nos níveis c1 (lesão ativa em esmalte não cavitado, lesão em esmalte cavitada e lesão em dentina) e c3 (lesão em dentina) de detecção de doença. Verificou-se também a ocorrência de efeitos adversos e outras queixas por entrevistas telefônicas com os responsáveis 7 a 10 dias após a primeira aplicação de verniz. Como resultado aos 18 meses de acompanhamento, 85 crianças do grupo teste e 92 do grupo controle foram examinadas. As diferenças nos incrementos médios de cárie, entre os grupos teste e controle, foram -0,9 (IC95%: -2,4;0,4) no nível c1 e -0,8 (IC95%:-1,9;0,2) no nível c3. O risco de desenvolvimento de novas lesões de cárie em dentina foi 30% (RR=0,70; IC 95%:0,49;0,99) menor nas crianças do grupo teste em relação às do grupo controle. Foram feitas entrevistas com 183 responsáveis sobre os efeitos adversos e a aceitabilidade da intervenção. Um relatou que a sua criança sentiu ardência na cavidade bucal após a aplicação do placebo e outro ficou incomodado com a coloração amarelada dos dentes da criança imediatamente após a aplicação do verniz fluoretado. A aplicação semestral de verniz fluoretado na dentição decídua de pré-escolares reduz o risco de desenvolver lesão de cárie dentária em dentina. Além disso, essa intervenção é segura e bem aceita pelos pais e pelas crianças.

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The aim of the present study was to assess the effectiveness and adverse effects on dental enamel caused by nightguard vital bleaching with 10% carbamide peroxide. This was accomplished through the interaction of researchers from different areas such as dentistry, materials engineering and physics. Fifty volunteers took part in the doubleblind randomized controlled clinical trial. They were allocated to an experimental group that used Opalescence PF 10% (OPA) and a control group that used a placebo gel (PLA). Fragments of human dental enamel from the vestibular surface of healthy premolars, extracted for orthodontic reasons, were fixed to the vestibular surface of the first upper molars of the volunteers for in situ observation. Bleaching was performed at night for 21 days. The observation periods included Baseline (BL), T0 (21 days), T30 (30 days after treatment) and T180 (180 days after treatment, only for the OPA group). Tooth color was assessed by comparing it with the Vita® scale and by the degree of satisfaction expressed by the volunteer. We also assessed adverse clinical effects, dental sensitivity and gingival bleeding. The study of adverse effects on enamel was conducted in vivo and in situ, using the DIAGNOdent® laser fluorescence device to detect mineral loss. Scanning electron microscopy (SEM) was used to check for superficial morphological alterations, energy dispersive spectrophotometry (EDS) to semiquantitatively assess chemical composition using the Ca/P ratio, and the x-ray diffraction (XRD) technique to observe alterations in enamel microstructure. The results showed that nightguard vital bleaching with 10% carbamide peroxide was effective in 96% of the cases, versus 8% for the PLA group. Dental sensitivity was present in 36% (9/25) of the cases. There was no significant association between gingival bleeding and the type of gel used (p = 1.00). In vivo laser fluorescence analysis showed no difference in values for the control group, whereas in the OPA group there was a statistically significant difference between baseline values in relation to the subsequent periods (p<0.01), with lower mean values for post-bleaching times. There was a significant difference between the groups for times T0 and T30. Micrographic analysis showed no enamel surface alterations related to the treatment performed. No significant alteration in Ca/P ratio was observed in the OPA group (p = 0.624) or in the PLA group (p = 0.462) for each of the observation periods, nor between the groups studied (p=0.102). The XRD pattern for both groups showed the presence of three-phase Hydroxyapatite according to JCPDS files (9-0432[Ca5(PO4)3(OH)], 18-0303[Ca3(PO4)2.xH2O] and 25-0166[Ca5(PO4)3(OH, Cl, F)]). No other peak associated to other phases was found, independent of the group analyzed, which reveals there was no disappearance, nucleation or phase transformation. Neither was there any alteration in peak pattern location. With the methodology and protocol used in this study, nightguard vital bleaching with 10% carbamide peroxide proved to be an effective and safe procedure for dental enamel

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The objective of this clinical study was to evaluate the effectiveness of the toothbrushing with and without fluoride and the daily fluoride rinse (NaF 0.05%) on produced white spot, in vivo. This was a clinical study, controlled, randomized and triple blind. Thirty patients were selected for orthodontics reasons from Orthodontics Specialization Course at the Brazilian Dental Association - Section of Rio Grande do Norte. In this study it was used 4 bicuspid upper and lower. They had orthodontic reason for extractions, in 35 days, at least. The sample had one hundred and twenty teeth that received orthodontic bands. The bands were fixed with polycarboxylate cement, and there was a space standardized between bands and one surface of teeth. The four bicuspid of each patients were randomized and nominated as A, B, C and D. These nominations determinated the sequence of the extractions and what was done in each tooth. All the patients had been submitted to the toothbrushing with or without fluoride for 35 days. After this period, the A tooth of each patient was extracted to serve as control. The others teeth (B, C and D) were extracted one by each week. The entire sample was analyzed through the clinical examination and by laser fluorescence (DIAGNOdent®) in three different times: before orthodontic bands, 28 days after fixed and then removed the bands and, the last one, 07 days after one of the three treatments (toothbrushing with or without fluoride, tooth paste with fluoride and mouth rinse with fluoride). At the beginning all groups (A, B, C and D) had the same conditions, no significant difference was found. The same situation was found in a clinical examination. The results of the DIAGNOdent® for the groups that used tooth paste without fluoride, with fluoride and mouth rinse with fluoride, after 28 days, there was no significant difference. Clinically, the white spot was formed in all teeth after 28 days. When it was compared the three treated groups, the group without fluoride in tooth paste had worst result than the others groups. But there was no significant association between the number of active and inactive white spots and the type of treatment that the teeth had received. The demineralization of the enamel surface, under the orthodontic bands, it happened in a few weeks. The exposition of the white spots in oral environmental resulted in an improvement, but it was not enough to return to the values from the base line, either for the toothbrushing and/or the use of fluorite mouth rinse. Mouth rinse and toothpaste with fluoride have showed to reduce the incidence of demineralization in the enamel, but none seems to be superior to another one in an in vivo study

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The objective of this study was to evaluate the effect of low laser power on the performance of anaerobic endurance of the quadriceps muscle in young subjects. Low-level laser therapy (LLLT) appears to decrease some indices of muscle fatigue. Most of these effects may be due to the influence of the laser on the muscles predominantly aerobic. Animal studies and clinical trials have already shown that the laser can improve the efficiency of mitochondrial metabolism for the resynthesis of adenosine triphosphate and thus slow down - or minimize, the deleterious effects of muscle fatigue. This research was characterized as an experimental study of the controlled clinical trial, randomized, blinded, attended by 93 volunteers, military, with ages between 18 and 19 years. The subjects were randomly allocated into three groups: Control (G1), Placebo (G2) and Laser (G3). All volunteers underwent an anthropometric assessment and a protocol Fatigue. This protocol was applied to an initial assessment (AV-1) for the collection of baseline data, and a final evaluation (AV-2). As the study variables, we used the blood lactate concentrations and indices of muscle power, as average power and peak velocity. The fatigue protocol consisted of a test of speed with twenty repetitions, performed on an exercise machine leg press 45º . In conclusion, it was found that, in this study, LLLT caused a significant increase in the Average of the Averages Powers, phase eccentric exercise in leg press 45º performed by young individuals

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A laserterapia de baixa potência (LBP) tem demonstrado recentemente ser capaz de aumentar a resistência à fadiga, bem como potencializar o desempenho neuromuscular através de seus efeitos metabólicos e fotoquímicos. Estudos anteriores mostraram que o LBP reduziu o estresse oxidativo do exercício, promovendo um retardo da fadiga muscular e minimizando seus efeitos deletérios. O objetivo desse estudo foi avaliar se a aplicação do LBP antes de um protocolo de fadiga teria efeito sobre o desempenho neuromuscular nas variáveis eletromiográficas e dinamométricas do músculo sóleo em sujeitos saudáveis. Esta pesquisa caracterizou-se como um estudo experimental do tipo ensaio clínico controlado, randomizado e cego, no qual participaram 60 voluntários de ambos os sexos, com faixa etária entre 18 e 28 anos e fisicamente ativos, segundo o questionário internacional para a prática de atividade física (IPAQ). Os sujeitos foram alocados randomicamente em três grupos: Controle (G1), Placebo (G2) e Laser (G3) e todos os voluntários foram submetidos a uma avaliação inicial (AV-1), um Protocolo de Fadiga e uma avaliação final (AV-2), compostas por contrações isocinéticas para flexão plantar a uma velocidade de 90°/s. Os resultados encontrados nesse estudo mostraram que não houve diferença estatística entre os três grupos da pesquisa nas variáveis eletromiográficas de RMS e Frequência Mediana, contudo, em relação à dinamometria, o grupo que recebeu a aplicação do Laser obteve um índice de fadiga significativamente menor (p=0,04) quando comparado aos grupos Controle e Placebo. Além disso, a aplicação do laser pré-exercício também resultou em um aumento nas variáveis de desempenho potência e trabalho. Com isso, pode-se concluir que o LBP foi capaz de melhorar o desempenho do sóleo em sujeitos saudáveis, justificado pelo aumento da resistência à fadiga

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To analyze the effects of electrical stimulation at two frequencies on the EMG parameters (EMG) and dynamometer, in muscles with different typing. MATERIALS AND METHODS: This is a controlled clinical trial, randomized and double blind. Sixty healthy volunteers (23.6 ± 4.2anos; 54.2 ± 7.7kg, 1.62 ± 0.009 cm) of both sexes were divided randomly into three groups: control group (CG), experimental group 1 (SG1) with application of the current Russian 30 HZ and experimental group 2 (EG2) at 70 Hz The volunteers performed an initial assessment (AV1) on the isokinetic dynamometer with three repetitions maximum voluntary isometric (MVC) for knee extension concomitant uptake of EMG for the VM muscle, VL and RF. Later, after application of NMES, they underwent an experimental protocol of isometric fatigue using 70% of MVIC, ending with the completion of a final assessment (AV2) in the same manner as the AV1. RESULTS: By analyzing the profile of the 60 subjects in three broad, VM showed a higher value of RMS behavior when the VL and RF (p = 0.03 and p = 0.02). With respect to Fmed the RF muscle (p = 0.001) showed a higher value for the VM. The VM muscle showed significant increases of Fmed (p = 0.05) after electrical stimulation at 70 Hz when compared the AV1 AV2 and RF showed significant decreases (p = 0.009) after stimulation at 30 Hz during the fatigue showed an increase RMS in the VM and VL, with a reduction in RF. For the variable Fmed was observed in three broad decline during fatigue. CONCLUSION: Our findings provide evidence that the muscles VM, VL and RF fiber typing are different besides indicating that the frequency of NMES tend to relate to the muscle stimulated. Finally suggests the surface EMG as a noninvasive method for characterizing muscle

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Pulmonary Rehabilitation, especially due to aerobic exercise, positive impact in reducing morbidity/mortality of patients with COPD, however the economic impact with costs of implementing simple programs of aerobic exercise are scarce. This is a blind randomized clinical trials, which aimed to evaluate the costs and benefits of a simple program of aerobic exercise in individuals with COPD, considering the financial costs of the Public Health System and its secondary endpoints. We evaluated lung function, the distance walked during six minutes of walking, the respiratory and peripheral muscle strength, quality of life related to health (QLRH), body composition and level of activity of daily living (ADL) before and after eight weeks of an aerobic exercise program consisting of educational guidance for both groups, control and intervention and supervised walks to the intervention group. The health costs generated in both groups were calculated following table Brazilian Public Health System. The sample consisted of forty patients, two being excluded in the initial phase of desaturation during the walk test six minutes. Were randomized into control and intervention group thirty-eight patients, three were excluded from the control group and one was excluded from the intervention group. At the end, thirty-four COPD comprised the sample, 16 in the control group and 18 in the intervention group (FEV1: 50.9 ± 14% pred and FEV1: 56 ± 0.5% pred, respectively). After for intervention, the intervention group showed improvement in meters walked, the sensation of dyspnea and fatigue at work, BODE index (p <0.01) in QLRH, ADL level (p <0.001) as well as increased strength lower limbs (p <0.05). The final cost of the program for the intervention group was R $ 148.75, including: assessments, hiking supervised by a physiotherapist and reassessments. No patient had exacerbation of IG, while 2 patients in the CG exacerbated, generating an average individual cost of R $ 689.15. The aerobic exercises in the form of walking showed significant clinical benefits and economic feasibility of its implementation, due to low cost and easy accessibility for patients, allowing them to add their daily practice of aerobic exercises

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The presence of fixed orthodontics appliances interfere on sanitation, allowing periodontal diseases to appear, despite the fact patients keep on visiting the dentist every month. This research aims to determine a protocol for the mechanical control of the dental biofilm performed by the professional. A protocol that was able to maintain the periodontal health of the patients under orthodontic treatment with fixed appliances, and in order to do so, it used a non-controlled, randomized and blind clinical essay. The sample involved 40 adolescents who were under the installation of fixed orthodontics appliances and it was divided in three groups, as follows: monthly controlled group (group 1) composed of 11 patients, the quarterly controlled group (group 2) with 16 patients and the semestrial controlled group (group 3) with 13 patients. For data collection, an interview and clinical exams with probing depth measurement, quantity of keratinized mucosa, Gingival Index and the Plaque Index were used. On the initial exam all patients received brushing guidelines as well as the professional control of dental biofilm, with periodontal scaler, Robinson s brush and prophylactic paste. However, Group 1 returned every month for control procedures; Group 2 every three months and Group 3 after six months. The intervention had a six-month duration (for all the three groups), when all the exams were repeated by another examiner who did not know which group each patient was inserted in. Finally, the research concluded that despite the fact there is no statistically significant difference among the three groups, clinically the patients from the monthly group presented a better response to professional control, with less accumulation of dental biofilm and less rate of gingival inflammation. Thus, the mechanical control of the dental biofilm performed by the professional could not avoid gingival increase, characterized by the raise of probing depth measurement, neither the quantity of keratinized mucosa

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The present study evaluated the influence of non-surgical periodontal treatment on the levels of C- reactive protein (hsCRP) in patients with chronic renal failure (CRF) in pretransplant. We conducted a controlled and randomized trial to evaluate the periodontal condition and plasma concentrations of hsCRP, albumin and transferrin in 56 dialysis patients divided into two groups: experimental and control. The study was conducted at the dental clinic of Family and Community Health s Unit (USFC), located in Onofre Lopes University Hospital (HUOL), Federal University of Rio Grande do Norte (UFRN), from December 2010 to November 2011. Severe periodontitis was the type of periodontal disease more common, affecting 78.6% of patients. Periodontal conditions, evaluated through the means of probing depth, clinical attachment level, bleeding index and plaque index, proved to be uniform for both groups at the initial examination. There were no differences in levels of inflammatory markers between the two groups. The analysis of the concentrations of hsCRP allowed classifying study participants as at high risk of developing cardiovascular disease. After completion of periodontal treatment in the experimental group, there was a statistically significant reduction of the mean of all periodontal parameters assessed; however this improvement of periodontal health was not accompanied by changes in the levels of hsCRP, albumin and transferrin in the evaluation time. Given this, the periodontal treatment did not promote the reduction of systemic inflammatory burden and risk of cardiovascular complications in patients with CRF

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There is a lack of clinical studies evaluating techniques of functional impression for partially edentulous arches. The aim of this double-blind non-randomized controlled clinical trial was to compare the efficacy of altered cast impression (ACI) and direct functional impression (DFI) techniques. The efficacy was evaluated regarding the number of occlusal units on denture teeth, mucosa integrity at 24-hour follow-up and denture base extension. The sample included 51 patients (female and male) with mean age of 58.96 years treated at Dental Department of UFRN. The patients, exhibiting edentulous maxilla and mandibular Kennedy class I, were divided into two groups (group ACI, n=29; group DFI, n=22). Clinical evaluation was based on the number of occlusal units on natural and/or artificial teeth, mucosa integrity at 24-hour follow-up, and denture base extension. Statistical analysis was conducted using the software SPSS 17.0® (SPSS Inc., Chicago, Illinois). Student T-test was used to reveal association between number of occlusal units and impression technique while chi-square test showed association between mucosa integrity and impression technique. Fischer s exact test was applied for association between denture base extension and impression technique at 95% level of significance. No significant difference was observed between the groups regarding number of occlusal units, mucosa integrity and denture base extension. The altered cast technique did not provide significant improvement in comparison to the direct technique when the number of occlusal units, mucosa integrity and denture base extension

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FUNDAMENTO: A sedação para a realização de cateterismo cardíaco tem sido alvo de preocupação. Benzodiazepínicos, agonistas alfa-2 adrenérgicos e opioides são utilizados para esse fim, entretanto, cada um destes medicamentos possui vantagens e desvantagens. OBJETIVO: Avaliar a eficácia do sufentanil e da clonidina como sedativos em pacientes submetidos a cateterismo cardíaco, observando o impacto dos mesmos sobre os parâmetros hemodinâmicos e respiratórios, a presença de efeitos colaterais, além da satisfação do paciente e do hemodinamicista com o exame. MÉTODOS: Trata-se de um ensaio clínico prospectivo, duplo-cego, randomizado e controlado, que envolveu 60 pacientes que receberam 0,1 µg/kg de sufentanil ou 0,5 µg/kg de clonidina antes da realização do cateterismo cardíaco. O escore de sedação segundo a escala de Ramsay, a necessidade de utilização de midazolam, os efeitos colaterais, os parâmetros hemodinâmicos e respiratórios foram registrados, sendo os dados analisados em 06 diferentes momentos. RESULTADOS: O comportamento da pressão arterial, da frequência cardíaca e da frequência respiratória foi semelhante nos dois grupos, entretanto, no momento 2, os pacientes do grupo sufentanil (Grupo S) apresentaram menor escore de sedação segundo a escala de Ramsay, e a saturação periférica da oxihemoglobina foi menor que o grupo clonidina (Grupo C) no momento 6. Os pacientes do Grupo S apresentaram maior incidência de náusea e vômito pós-operatório que os pacientes do Grupo C. A satisfação dos pacientes foi maior no grupo clonidina. Os hemodinamicistas mostraram-se satisfeitos nos dois grupos. CONCLUSÃO: O sufentanil e a clonidina foram efetivos como sedativos em pacientes submetidos a cateterismo cardíaco. (Arq Bras Cardiol. 2011; [online].ahead print, PP.0-0)

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Pós-graduação em Pesquisa e Desenvolvimento (Biotecnologia Médica) - FMB

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Pós-graduação em Pesquisa e Desenvolvimento (Biotecnologia Médica) - FMB

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)