825 resultados para Controlled clinical-trial


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Context and Objective: Lipasomial daunorubicin has been used to treat hematological malignancies, including multiple myelomo (MM). The goal was to evaluate efficacy, side-effects and toxicity of liposomal daunorubicin and dexamethasone (DD Protocol). Design and Setting: Prospective study of Sírio-Libonês, São Camilo, Brasil and Alemão Oswaldo Cruz hospitals. Methods: Twenty consecutive patients with active MM received four cycles of liposomal daunorubicin intravenously for two hours (25-30 mg/m 2/day) on three consecutive days per month, with oral dexamethasone, (10 mg every six hours) on four consecutive days three times a month. Results: The male/female ratio was 1:1 and median age 60. Nine patients were stage IIA, ten IIIA and one IIIB. The median from diagnosis to starting DD was 13 months. All patients received four cycles, except one. Fifteen had already received chemotherapy before DD. Responses of > 50% reduction in serum monoclonal paraprotein were observed in six patients after first cycle (30%), six after second (30%) and four after third (20%), while four (20%) did not obtain this. Initially, 17 patients (85%) had anemia: 12 (70%) achieved correction. Progressive disease was observed in three patients (15%), while one had minimal response, four (20%) partial and 12 (60%) complete. Hemotologlical toxicity was acceptable: three patients (15%) had neutrophils < 1,000/mm 3; none had thrombocyfopenia. Gastrointestinal toxicity was mild: nausea (10%), anorexio (15%) and no vomiting. Conclusions: This treatment has mild toxicity and good response rate. It may therefore be feasible before autologous bone marraw transplantation.

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Introduction: Hypercholesterolemia is an important risk factor for cardiovascular disease, the first cause of death and third reason for hospital admissions in Brazil. The reduction of serum cholesterol levels reduces morbidity and mortality from cardiovascular disease. The present study evaluated the efficacy and safety of atorvastatin in the treatment of Brazilian patients with primary hypercholesterolemia (types IIA and IIB dyslipidemias). Patients and methods: After a 4-week wash-out period, 152 patients were treated with atorvastatin at the initial dose of 10 mg/day. According to treatment efficacy within the first 8 weeks this dose could be increased to 20 mg/day. Treatment lasted for a total of 16 weeks, and its efficacy was evaluated by the reduction of serum levels of LDL-cholesterol, total cholesterol, HDL-cholesterol, and triglycerides, as well as by the propotion of patients that achieved the target levels recommended by the National Cholesterol Education Program - Adult Treatment Panel II (NCEP ATP II) Results: The analysis of efficacy was conducted in 145 patients. Atorvastatin led to significant reductions in the levels of LDL-cholesterol after 8 and 16 weeks of treatment (P<0.001 for both comparisons). The relative reduction of such levels was 38% (P<0.001 after 8 and 16 weeks). Atorvastatin also led to significant reductions of total cholesterol and triglycerides. At the end of the study, 81% of patients achieved the target LDL-cholesterol levels recommended by NCEP ATP II. Treatment was well tolerated, and was interrupted due to creatine phosphokinase elevation in only one patient. Conclusion: Atorvastatina is efficacious and safe in the treatment of patients with primary hypercholesteromia. © Copyright Moreira Jr. Editora. Todos os direitos reservados.

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Purpose: The aim of this study was to evaluate the interfacial microgap with different materials used for pulp protection. The null hypothesis tested was that the combination of calcium hydroxide, resin-modified glass ionomer, and dentin adhesive used as pulp protection in composite restorations would not result in a greater axial gap than that obtained with hybridization only. Materials and Methods: Standardized Class V preparations were performed in buccal and lingual surfaces of 60 caries-free, extracted human third molars. The prepared teeth were randomly assessed in six groups: (1) Single Bond (SB) (3M ESPE, St. Paul, MN, USA); (2) Life (LF) (Kerr Co., Romulus, MI, USA) + SB; (3) LF + Vitrebond (VT) (3M ESPE) + SB; (4) VT + SB; (5) SB + VT; (6) SB + VT + SB. They were restored with microhybrid composite resin Filtek Z250 (3M ESPE), according to the manufacturer's instructions. However, to groups 5 and 6, the dentin bonding adhesive was applied prior to the resin-modified glass ionomer. The specimens were then thermocycled, cross-sectioned through the center of the restoration, fixed, and processed for scanning electron microscopy. The specimens were mounted on stubs and sputter coated. The internal adaptation of the materials to the axial wall was analyzed under SEM with × 1,000 magnification. Results: The data obtained were analyzed with nonparametric tests (Kruskal-Wallis, p ≤ .05). The null hypothesis was rejected. Calcium hydroxide and resin-modified glass ionomer applied alone or in conjunction with each other (p < .001) resulted in statistically wider microgaps than occurred when the dentin was only hybridized prior to the restoration. ©2005 BC Decker Inc.

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Objective: To measure and compare the activity of the masseter, temporalis and buccinator muscles in different infant feeding methods. Method: Cross-sectional study of 60 full-term infants with no intercurrent diseases, aged between two and three months, classified into the following groups: 1) exclusive breastfeeding; 2) breastfeeding plus bottle-feeding; and 3) exclusive breastfeeding plus cup feeding. Surface electromyography was performed during infant feeding. The Krushal-Wallis test was used, complemented by multiple paired comparisons of the groups. A 5% significance level was chosen for the tests. Results: Statistically higher results were verified in the breastfeeding group in relation to the bottle-feeding one, both in the range of movement and the mean contraction of the masseter. With regard to the temporalis muscle, statistically higher results were found in the breastfeeding group comparatively to the bottle-feeding one. As to the buccinator muscle, statistically higher results were observed in the breastfeeding group in relation to the bottle-feeding one, although in this case, the difference concerned only the range of contraction. Conclusion: The similarities between the muscle activity in the breastfeeding and in the cup-feeding groups suggests that cup-feeding can be used as an alternative infant feeding method, being better than bottle-feeding, due to the hyperactivity of the buccinator muscle, which could result in changes to the structural growth and development of the stomatognathic system functions. Copyright © 2006 by Sociedade Brasileira de Pediatria.

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Acid etching promotes microporosities on enamel surface, which provide a better bonding surface to adhesive materials. The purpose of this study was to comparatively analyze the microstructure of enamel surface after etching with 37% phosphoric acid or with two self-etching primers, Non-rinse conditioner (NRC) and Clearfil SE Bond (CSEB) using scanning electron microscopy. Thirty sound premolars were divided into 3 groups with ten teeth each: Group 1: the buccal surface was etched with 37% phosphoric acid for 15 seconds; Group 2: the buccal surface was etched with NRC for 20 seconds; Group 3: the buccal surface was etched with CSEB for 20 seconds. Teeth from Group 1 were rinsed with water; teeth from all groups were air-dried for 15 seconds. After that, all specimens were processed for scanning electron microscopy and analyzed in a Jeol 6100 SEM. The results showed deeper etching when the enamel surface was etched with 37% phosphoric acid, followed by NRC and CSEB. It is concluded that 37% phosphoric acid is still the best agent for a most effective enamel etching.

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The aim of this study was to determine the cutting ability of chemical vapor deposition (CVD) diamond burs coupled to an ultrasonic dental unit handpiece for minimally invasive cavity preparation. One standard cavity was prepared on the mesial and distal surfaces of 40 extracted human third molars either with cylindrical or with spherical CVD burs. The cutting ability was compared regarding type of substrate (enamel and dentin) and direction of handpiece motion. The morphological characteristics, width and depth of the cavities were analyzed and measured using scanning electron micrographs. Statistical analysis using the Kruskal-Wallis test (p < 0.05) revealed that the width and depth of the cavities were significantly greater when they were prepared on dentin. Wider cavities were prepared when the cylindrical CVD bur was used, and deeper cavities resulted from preparation with the spherical CVD bur. The direction of handpiece motion did not influence the size of the cavities, and the CVD burs produced precise and conservative cutting.

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Introduction: The force delivered during rapid maxillary expansion (RME) produces areas of compression on the periodontal ligament of the supporting teeth. The resulting alveolar bone resorption can lead to unwanted tooth movement in the same direction. The purpose of this study was to evaluate periodontal changes by means of computed tomography after RME with tooth-tissue-borne and tooth-borne expanders. Methods: The sample comprised 8 girls, 11 to 14 years old, with Class I or II malocclusions with unilateral or bilateral posterior crossbites Four girls were treated with tooth-tissue-borne Haas-type expanders, and 4 were treated with tooth-borne Hyrax expanders. The appliances were activated up to the full 7-mm capacity of the expansion screw. Spiral CT scans were taken before expansion and after the 3-month retention period when the expander was removed. One-millimeter thick axial sections were exposed parallel to the palatal plane, comprising the dentoalveolar area and the base of the maxilla up to the inferior third of the nasal cavity. Multiplanar reconstruction was used to measure buccal and lingual bone plate thickness and buccal alveolar bone crest level by means of the computerized method. Results and Conclusions: RME reduced the buccal bone plate thickness of supporting teeth 0.6 to 0.9 mm and increased the lingual bone plate thickness 0.8 to 1.3 mm. The increase in lingual bone plate thickness of the maxillary posterior teeth was greater in the tooth-borne expansion group than in the tooth-tissue-borne group. RME induced bone dehiscences on the anchorage teeth's buccal aspect (7.1 ± 4.6 mm at the first premolars and 3.8 ± 4.4 mm at the mesiobuccal area of the first molars), especially in subjects with thinner buccal bone plates. The tooth-borne expander produced greater reduction of first premolar buccal alveolar bone crest level than did the tooth-tissue-borne expander. © 2006 American Association of Orthodontists.

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Objective: Comparison of the clinical efficacy of 4% articaine in relation to 2% mepivacaine, both with 1:100,000 epinephrine, in the prevention of postoperative pain after lower third molar removal. Study design: Twenty patients underwent removal of bilateral lower third molars under local anesthesia (articaine or mepivacaine) in 2 separate appointments, in a double-blind, randomized, and crossed manner. Objective and subjective parameters were recorded for paired comparison of postoperative courses. Results: Duration of analgesia provided by articaine and mepivacaine was 198.00 ± 25.86, and 125.40 ± 13.96 min, respectively (P = .02), whereas the duration of anesthesia was 273.80 ± 15.94 and 216.85 ± 20.15 min, respectively (P = .06). Both solutions exerted no important effects upon arterial pressure, heart rate, or oxygen saturation (P > .05). Conclusions: Articaine provides a longer period of analgesic effect and a tendency for a longer period of anesthesia as compared to mepivacaine. The presence of a vasoconstrictor agent in local anesthetic solutions does not seem to influence hemodynamic parameters during lower third molar removal in healthy subjects. © 2006 Mosby, Inc. All rights reserved.

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The purpose of this investigation was to make a systematic review of the medical literature in order to compare the efficacy of GnRH antagonists and agonists for poor responders to ovarian stimulation. According to the data collected, the use of GnRH antagonist protocols showed better results in comparison to long protocols with a GnRH agonist regarding the following aspects: lower cycle cancellation rate due to poor ovarian response; higher number of oocytes retrieved; higher clinical pregnancy rate per initiated cycle. Nevertheless, these results were not observed when the flare-up protocols of GnRH agonists were used. Moreover the number of oocytes retrieved with GnRH agonist was significantly higher in relation to the GnRH antagonist.

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The purpose of this review was to assess the efficacy of recombinant LH (r-LH) supplementation for controlled ovarian stimulation in recombinant FSH (r-FSH) and GnRH-agonist (GnRH-a) protocol for IVF/ICSI cycles. Search strategies included on-line surveys of databases from 1990 to 2006. Four trials fulfilled the inclusion criteria (Lisi et al. 2002, Humaidan et al. 2004, Marrs et al. 2004, Tarlatzis et al. 2006). When the review was carried out advantages were observed for the r-LH supplementation protocol with respect to a fewer days of stimulation, a fewer total amount of r-FSH administered and a higher serum estradiol levels on the day of hCG administration. However, these differences were not observed in number of oocyte retrieved, number of mature oocytes, clinical pregnancy per oocyte retrieval, implantation and miscarriage rates. Nevertheless, more randomized controlled trials are necessary before evidence-based recommendations regarding exogenous r-LH supplementation in ovarian stimulation protocols with r-FSH and GnRH-a for assisted reproduction treatment can be provided.

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Laser-assisted hatching is little documented in the literature regarding its efficacy in cryopreserved-thawed (CT) embryo transfer cycles. The aim of the present study was to evaluate in a randomized manner the efficacy of thinning one quarter of the zona pellucida of CT embryos to a depth of 50-80% of the original thickness, via laser treatment (the qLZT-AH procedure), in improving implantation and pregnancy rates. Two populations were studied: population I, patients who had all their supernumerary embryos cryopreserved, regardless of their morphology, and population II, patients at risk of ovarian hyperstimulation syndrome who had all their embryos cryopreserved. Artificial and natural protocols were used for the embryo transfers. A total of 350 laser-thinned CT embryos were compared with 352 intact zona embryos. No difference in implantation or pregnancy rate was found after using qLZT-AH in either population. These findings suggest that qLZT-AH should not be routinely performed in cryopreserved embryo programmes.

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The aim of this study was to analyze, under scanning electron microscopy (SEM), the morphologic characteristics of root surfaces after application of CarisolvTM gel in association with scaling and root planing (SRP). Sixty periodontally compromised extracted human teeth were randomly assigned to 6 groups: 1) SRP alone; 2) passive topical application of CarisolvTM + SRP; 3) active topical application of CarisolvTM + SRP; 4) multiple applications of CarisolvTM + SRP; 5) SRP + 24% EDTA; 6) topical application of CarisolvTM + SRP + 24% EDTA. CarisolvTM gel was applied to root surfaces for 30 s, followed by scaling and root planing, consisting of 50 strokes with Gracey curettes in an apical-coronal direction, parallel to the long axis of the tooth. The only exception was group 4, in which the roots were instrumented until a smooth, hard and glass-like surface was achieved. All specimens were further analyzed by SEM. The results showed that the treatment with CarisolvTM caused significant changes in root surface morphology of periodontally compromised teeth only when the chemical agent was actively applied (burnishing technique). CarisolvTM failed to remove the smear layer completely, especially with a single application, independently of the method of application. Multiple applications of CarisolvTM were necessary to achieve a smear layer reduction comparable to that obtained with 24% EDTA conditioning.

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The purpose of this study was to evaluate the effectiveness of subgingival application of Carisolv™ gel as an adjunctive therapy to scaling and root planing (SRP) on calculus removal compared to conventional instrumentation. Forty-five teeth requiring extraction due to severe periodontal disease were randomized to the following treatments: 1) SRP alone; 2) placebo gel + SRP; 3) Carisolv™ gel + SRP. Either test or placebo gel was applied subgingivally for 1 min and then the root were instrumented until a smooth and calculus-free surface was achieved. Instrumentation time and the number of strokes required were recorded. After extraction, the efficacy of root surface instrumentation was measured by percentage of remaining calculus. There was no statistically significant difference (p>0.05) between the treatment groups regarding either time required for instrumentation or the percentage of residual calculus. The subgingival application of Carisolv™ gel prior to SRP did not provide any additional benefit to root instrumentation compared to scaling and root planing alone.

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The purpose of this study was to test the hypothesis that mechanical polishing methods of ceramic surfaces allow similar superficial roughness to that of glazed surfaces. Twenty-five Vitadur Alpha ceramic discs (5 mm x 2 mm) were prepared according to the manufacturer's specifications. All specimens were glazed and randomly assigned to 5 groups (n=5), according to finishing and polishing protocols: G1: glazed (control); G2: diamond bur finishing; G3: G2 + silicon rubber tip polishing; G4: G3 + felt disc/diamond polishing paste; G5: G3 + felt disc impregnated with fine-particle diamond paste. Next, surface roughness means (Ra - μm) were calculated. Qualitative analysis was made by scanning electron microscopy. Surface roughness data were submitted to ANOVA and Tukey's test at 5% significance level. G1 and G4 were statistically similar (p>0.05). G2 presented the highest roughness means (p<0.05) followed by groups G3, G5, G4 and G1 in a decreasing order. The hypothesis was partially confirmed as only the mechanical polishing (G4) produced similar superficial roughness to that of surface glazing, although finishing and polishing are technically critical procedures.

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This study aims to compare the efficacy of recombinant LH (rLH) supplementation for ovarian stimulation in gonadotrophin-releasing hormone-antagonist protocol for IVF/intracytoplasmic sperm injection cycles. Search strategies included online surveys of databases. The fixed effects model was used for odds ratio (OR) and effect size (weighted mean difference, WMD). Five trials fulfilled the inclusion criteria. When the meta-analysis was carried out, advantages were observed for the LH supplementation protocol with respect to higher serum oestradiol concentrations on the day of human chorionic gonadotrophin administration (P < 0.0001; WMD: 514, 95% CI 368, 660) and higher number of mature oocytes (P = 0.0098; WMD: 0.88, 95% CI 0.21, 1.54). However, these differences were not observed in the total amount of recombinant FSH (rFSH) administered, days of stimulation, number of oocytes retrieved, the clinical pregnancy rate per oocyte retrieval, the implantation rate and miscarriage rate. This result demonstrates that the association of rLH with rFSH may prevent any decrease in oestradiol after antagonist administration and that a significantly higher number of mature oocytes was available for laboratory work. Nevertheless, it failed to show any statistically significant difference in clinically significant end-points in IVF (implantation and pregnancy rates). Additional randomized controlled trials are needed to confirm these results further. © 2007 Published by Reproductive Healthcare Ltd.