215 resultados para controlled clinical trial


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Two auxiliary methods of diagnosing nasopharyngeal airway obstruction were compared. Cephalometric radiography and nasopharyngeal videoendoscopy were evaluated for efficacy in terms of reproducibility and validity. Thirty orthodontic patients (7 to 12 years of age) seeking otorhinolaryngologic treatment for mouth breathing, or mouth and nose breathing, had nasopharyngeal endoscopy and radiographic examinations performed on the same day. Two otorhinolaryngologists analyzed the results. Nasopharyngeal endoscopy was more reliable in identifying all the obstructive nasopharyngeal processes. Endoscopy obtained kappa index scores of almost perfect agreement for diagnosis of posterior nasal septum deviation, of substantial agreement for anterior nasal septum deviation and lower turbinate hypertrophy, and of moderate agreement for middle turbinate hypertrophy. Lateral cephalometric radiography obtained scores of perfect agreement for imaging hypertrophy of the middle turbinate, of almost perfect agreement for imaging hypertrophy of the posterior portion of the inferior turbinate, and of substantial agreement for imaging hypertrophy of the inferior turbinate. Radiographic diagnoses of hypertrophy of the middle and lower turbinates exhibited high sensitivity and low specificity when compared with diagnoses by nasopharyngeal endoscopy.

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Objective: The purpose of this study was to evaluate the effect of erbium:yttrium-aluminum-garnet laser instrumentation of root surfaces on the morphology of fibroblasts from continuous lineage. Method and materials: Dentinal slices with 4 mm2 of surface area were obtained from teeth extracted for severe periodontal involvement. Specimens were assigned to one of three treatment groups: group 1, application of the laser with an energy level of 250 mJ at 103 pulses per second; group 2, application of the laser with an energy level of 80 mJ at 166 pulses per second; and group 3, similar to group 2, but with concomitant water irrigation of the device. The specimens were incubated in multiwell plates containing cell culture media. After 24 hours, the specimens were submitted to routine preparation for scanning electron microscopy. Three independent and blind examiners used photomicrographs to evaluate the morphology of the fibroblasts: 0 = without cells; 1 = flat cells; 2 = round cells; and 3 = combination of round and flat cells. Results: Statistical analysis indicated that there were significant differences among treatment groups and that group 3 was significantly different from groups 1 and 2. Conclusion: There was no difference between groups 1 and 2 in the morphology of fibroblasts. Laser instrumentation with concomitant irrigation impaired the adhesion of fibroblasts to dentinal surfaces.

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OBJECTIVE: The aim of this study was to evaluate the resistance to fracture of intact and restored human maxillary premolars. METHOD AND MATERIALS: Thirty noncarious human maxillary premolars, divided into three groups of 10, were submitted to mechanical tests to evaluate their resistance to fracture. Group 1 consisted of intact teeth. Teeth in group 2 received mesio-occlusodistal cavity preparations and were restored with direct resin composite restorations. Teeth in group 3 received mesio-occlusodistal cavity preparations and were restored with ceromer inlays placed with the indirect technique. After restoration, teeth were stored at 37 degrees C for 24 hours and then thermocycled for 500 cycles at temperatures of 5 degrees C and 55 degrees C. RESULTS: Statistical analysis revealed that group 3 (178.765 kgf) had a significantly greater maximum rupture load than did group 1 (120.040 kgf). There was no statistically significant difference between groups 1 and 2 or between groups 2 and 3. CONCLUSION: Class II cavity preparations restored with indirect ceromer inlays offered greater resistance to fracture than did intact teeth. The fracture resistance of teeth restored with resin composite was not significantly different from that of either the ceromer or intact teeth.

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The utilization of dentifrices with low fluorine concentration, for children under 6 years of age, has been suggested to reduce the risks of dental fluorosis. However, in order to have anticariogenic potential, the dentifrice should form loosely-bound fluorine (CaF2) on dental enamel. Considering that the formation of CaF2 is a function inversely related to pH, dentifrices with pH 5.5, with 275, 550 and 1,100 ppm F (NaF/silica) were developed in order to assess dose-response effects. A comparison between those dentifrices, a placebo product and the Crest toothpaste (positive control - standard) was carried out. Furthermore, the bioavailability of dentifrices, in terms of formation of total fluorine (TF), CaF2, and fluorapatite (FA) on human dental enamel, was evaluated. An ion-specific electrode was utilized for the determination of the dosage of fluorine. The results revealed that the dentifrice with 550 ppm F was more effective than both the placebo and the dentifrice with 275 ppm, presenting no difference in relation to the positive control (p > 0.05). A dose-effect correlation was observed as to the CaF2 formed. In conclusion, the modified formulation with 550 ppm F can be considered as effective as the standard dentifrice with 1,100 ppm, and its utilization would be safer with regard to dental fluorosis.

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Objective. The aim of this in vitro study was to evaluate the interaction between two sources of fluoride (restorative systems and dentifrices) in inhibiting artificial root caries development. Methods. One hundred and eighty tooth segments were embedded in polyester resin, and sanded flat. Cylindrical cavities 1.0 mm-deep and 1.5 mm-diameter were prepared in root dentin and randomly restored by fluoride-containing restorative systems: Ketac-fil/Espe (Ke), Fuji II LC/GC Corp (Fj), F2000/3M (F2), Surefil/Dentsply (Su) or a control: Filtek Z250/3M (Z2). Ten experimental groups were made to test the association among the five restorative systems and two dentifrices: with F - (Sensodyne Baking Soda) or without F- (Sensodyne Original) (n = 18). After surface polishing, a 1 mm-wide margin around the restorations was demarcated and initial dentin surface Knoop microhardness values (KHNi) were obtained. The specimens were submitted to a pH-cycling model, and to applications of slurries of dentifrice. Afterwards the final dentin surface Knoop microhardness values (KHNf) were measured. Results. The differences between KHNi and KHNf, and the covariate KHNi were considered by the ANCOVA and Tukey's test (α = 0.05). The interaction between restorative system and dentifrice was statistically significant (p = 0.0026). All restorative systems provided some protection against artificial caries challenge when associated with the fluoride-containing dentifrice treatment. The means (standard deviation) of reductions in Knoop hardness values for systems associated with the fluoride-containing dentifrice were: Ke: 40.0(1.02)a, Fj: 41.9(1.02)b, F2: 43.3(1.04)c, Su: 43.5(1.00)c, Z2: 44.0(1.02)c; and with the non-fluoride-containing dentifrice were: Ke: 42.9(1.02)a, Fj: 44.7(1.01)b, F2: 45.2(1.09)bc, Su: 46.0(0.99)c, Z2: 46.6(0.99)c (statistical differences were expressed by different letters). Conclusion. The cariostatic effect shown by the fluoride-containing dentifrice could enhance that shown by Ketac-fil and Fuji II LC, and could mask that shown by F2000. © 2002 Elsevier Science Ltd. All rights reserved.

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Study Objectives: To evaluate the effects of intraoperative skin-surface warming with and without 1 hour of preoperative warming, in preventing intraoperative hypothermia, and postoperative hypothermia, and shivering, and in offering good conditions to early tracheal extubation. Design: Prospective, randomized, blind study. Setting: Teaching hospital. Patients: 30 ASA physical status I and II female patients scheduled for elective abdominal surgery. Interventions: Patients received standard general anesthesia. In 10 patients, no special precautions were taken to avoid hypothermia. Ten patients were submitted to preoperative and intraoperative active warming. Ten patients were only warmed intraoperatively. Measurements and Main Results: Temperatures were recorded at 15-minute intervals. The patients who were warmed preoperatively and intraoperatively had core temperatures significantly more elevated than the other patients during the first two hours of anesthesia. All patients warmed intraoperatively were normothermic only at the end of the surgery. The majority of the patients warmed preoperatively and intraoperatively or intraoperatively only were extubated early, and none had shivering. In contrast, five unwarmed patients shivered. Conclusions: One hour of preoperative warning combined with intraoperative skin-surface warming, not simply intraoperative warming alone, avoided hypothermia caused by general anesthesia during the first two hours of surgery. Both methods prevented postoperative hypothermia and shivering and offered good conditions for early tracheal extubation. © 2003 by Elsevier B.V.

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This study was undertaken to verify the effect of a daily intake of a new fermented soy milk produced with Enterococcus faecium and Lactobacillus jugurti on the serum lipid levels in normocholesterolemic middle-aged men. The study was randomized, double-blind and placebo-controlled and was performed for a period of 6 weeks. Forty-four normocholesterolemic healthy, male volunteers, aged 40-55 years old were randomly separated in two groups: The F-group received 200 ml of the fermented product daily and the P-group received 200 ml of placebo (chemically fermented). The blood samples were drawn initially and after 3 and 6 weeks and serum values for total cholesterol, HDL-cholesterol and triglyceride were determined. The LDL-cholesterol value was estimated. No significant changes in the fermented group (F) were observed for total cholesterol, LDL-cholesterol or triglyceride levels, while the HDL-cholesterol level was significantly higher (p≤ 0,05) after 6 weeks. The total cholesterol and LDL-cholesterol levels were significantly higer (p≤ 0,05) in the placebo group (P), but no changes were found for the HDL-cholestrol and triglyceride levels during the experimental period. In conclusion, the intake of 200 ml/day of the fermented soy milk, produced with E.faecium and L. jugurti, for 6 weeks, did not affect the serum total cholesterol and LDL-cholesterol, and led an increase of 10% in the HDL-cholesterol level.

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The electromyographic activity of the shoulder muscles deltoid - anterior portion (DA) and pectoralis major - clavicular portion (PMC) was tested on 24 male volunteers using a 2 channel TEC A TE4 electromyograph and Hewlett Packard surface electrodes during the execution of four different modalities of frontal-lateral cross, dumbbells exercises. The results showed that all of the tested exercises developed high levels of action potential for both muscles. So, we jusfity the indication of all of them for physical fitness programmes for DA and PMC. Some suggestions to the use of the tested exercises are presented.

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Loss of function, muscle inflammation, and pain are some of the signs and symptoms of temporomandibular dysfunction (TMD). Pharmacological strategies to minimize the clinical manifestation of these disorders often focus on blocking or inhibiting the pain-causing symptom. Resources such as muscle-relaxants, anxiety-relief drugs, and splint therapy are often used to reduce muscular hyperactivity related to TMD muscle pain. This study compares the effect of a randomly ordered association of occlusal splint therapy (S), nonsteroid anti-inflammatory with a muscle-relaxant drug (orphenadrine citrate) (O), and an anxiety-relief drug (benzodiazepine) (B), to ease painful TMD muscle symptoms. Clinical and anamnestic analyses were recorded in accordance with the Helkimo TMD index and applied before and after treatments. Twenty-one group two Helkimo TMD adult female patients were treated, all of whom were subjected to the three random therapeutic associations proposed: SBO, BOS, and OSB. The same operator applied the three specific associations over a period of 21 days in the proposed sequence, seven days for each therapy. The results show that all the groups presented the best results in terms of relief from pain after the therapeutic association (28.5% showed a decrease and 47.6% showed an absence of symptoms). No significant difference was observed among association therapeutic protocols. Copyright © 2003 by CHROMA, Inc.

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The purpose of this study was to compare the removal of root surface smear layer following active application of EDTA gel and EDTA-T (texapon) gel in different concentrations (5%, 10%, 15%, 20% and 24%), using scanning electron microscopy. A total of 220 dentin blocks obtained from the root surfaces of extracted teeth were divided into 3 groups: Group I - (control) application of saline solution (n = 20); Group II - EDTA gel (pH 7.0) was applied in the following concentrations: 5%, 10%, 15%, 20% and 24% (n = 100); Group III - EDTA-T gel (pH 7.0) applied in the same concentrations described above (n = 100). The photomicrographs were evaluated by one calibrated examiner using a smear layer removal index and following statistical analysis (Kruskal-Wallis test). The results demonstrated that the specimens treated with EDTA and EDTA-T gel presented a better smear layer removal than the control group (p < 0.01); no statistically significant differences were observed between the EDTA and EDTA-T groups and between the concentrations tested (Mann-Whitney, p > 0.05). Within the limits of this study, it can be concluded that all treatment modalities effectively removed the smear layer from the root surface. The addition of texapon into the EDTA gel formulation did not increase its effectiveness.

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Most hypertensive patients need more than one drug to reach recommended blood-pressure targets. We investigated the effects on 24-h ambulatory blood pressure (ABP) of the angiotensin-receptor blocker, valsartan, in combination with hydrochlorothiazide (HCTZ), compared with the calcium-channel blocker amlodipine in a Brazilian population in a multicentre, double-blind, double-dummy, parallel group, controlled study in 373 patients with essential hypertension. After a 2-week washout period, patients with a mean sitting systolic blood pressure (SBP) of 160-190 mmHg were randomized to receive either valsartan 160 mg o.d., or amlodipine 5 mg o.d. for 2 weeks and subsequently force-titrated to valsartan 160 mg/HCTZ 25 mg o.d. or amlodipine 10 mg o.d. This regimen was continued until the end of the study at week 8. The primary efficacy parameter was the change from baseline to week 8 in mean 24-h SBP. Secondary endpoints were change in mean 24-h diastolic blood pressure (DBP), tolerability and safety of treatments. Valsartan/HCTZ achieved a mean reduction in systolic ABP of -19.1 ± 11.3 mmHg compared with -20.7 ± 12.0 mmHg with amlodipine (p = 0.324 for the comparison) and in diastolic ABP by -11.1 ± 7.4 mmHg vs -11.6 ± 7.2 mmHg by amlodipine (p = 0.853 for the comparison). The valsartan/HCTZ group exhibited markedly lower rates of adverse events and discontinuations than the amlodipine group. Peripheral oedemas were far more frequent with amlodipine than with valsartan/HCTZ (1.6% with valsartan/HCTZ; 16.8% with amlodipine). Thus, the valsartan 160 mg/HCTZ 25 mg combination appears to be as efficacious as amlodipine 10 mg in this patient population but better tolerated.

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The influence of endometrial cavity length (ECL) on implantation and pregnancy rates after 400 embryo transfers was studied prospectively in a population with the indication of IVF/intracytoplasmic sperm injection (ICSI). The tip of the transfer catheter was placed above or below the half point of the ECL in a randomized manner. Two analyses were performed: (i) absolute position (AP); embryo transfers were divided into three groups according to the distance between the end of the fundal endometrial surface and the catheter tip (DTC - distance tip catheter): AP 1 (n = 212), 10-15 mm; AP 2 (n = 158), 16-20 mm; and AP 3 (n = 30), ≥21 mm. (ii) relative position (RP) - embryo transfers were divided into four groups according to their RP [RP = (DTC/ECL) × 100]: RP 1 (n = 23), ≤40%; RP 2 (n = 177), 41-50%; RP 3 (n = 117), 51-60%; and RP 4 (n = 83), ≥61%. Analysis based on relative distance revealed significantly higher implantation and pregnancy rates (P < 0.05) in more central areas of the ECL. However, analysis based on absolute position did not reveal any difference. In conclusion, the present results demonstrated that implantation and pregnancy rates are influenced by the site of embryo transfer, with better results being obtained when the catheter tip is positioned close to the middle area of the endometrial cavity. In this respect, previous analysis of the ECL is the fundamental step in establishing the ideal site for embryo transfers.

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Tamoxifen was proven to reduce the incidence of breast cancer by 49% in women at increased risk of the disease in the Breast Cancer Prevention Trial. In order to identify potential candidates to explain the preventive effect induced by tamoxifen on breast cancer, normal breast tissue obtained from 42 fibroadenoma patients, randomly assigned to receive placebo or tamoxifen, was analyzed by the reverse Northern blot and RT-PCR techniques. The cDNA fragments used on Northern blot membranes were generated by the Human Cancer Genome Project funded by the Ludwig Institute for Cancer Research and FAPESP (Fundação de Amparo à Pesquisa do Estado de São Paulo, Brazil). Total RNA was obtained from normal breast tissue from patients with clinical, cytological and ultrasound diagnosis of fibroadenoma. After a 50-day treatment with tamoxifen (10 or 20 mg/day) or placebo, normal breast tissue adjacent to the tumor was collected during lumpectomy with local anesthesia. One differentially expressed gene, Calcium/calmodulin-dependent protein kinase II (CaMKII), was found to be down-regulated during TAM treatment. CaMKII is an ubiquitous serine/threonine protein kinase that has been implicated in the diverse effects of hormones utilizing Ca2+ as a second messenger as well as in c-fos activation. These results indicate that the down-regulation of CaMKII induced by TAM might represent alternative or additional mechanisms of the action of this drug on cell cycle control and response to hormones in normal human breast tissue.

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Implantation failure after IVF is one of the factors associated with a reduced chance of pregnancy for some patients. Assisted hatching methodologies are designed to facilitate the embryo's escape from the zona pellucida, and this strategy has been suggested as a means of improving pregnancy rates in patients with previous implantation failure. The aim of this prospective and randomized study was to evaluate the efficacy of quarter-laser zona thinning assisted hatching (qLZT-AH) in improving the implantation of embryos in patients with previous implantation failure. A total of 150 patients with a history of previous implantation failure were treated with intracytoplasmic sperm injection, and allocated into two groups: group 1, only one previous implantation failure, and group 2, repeated implantation failures. The patients in each group were randomized at the time of embryo transfer into a control group (no qLZT-AH) or experimental group where qLZT-AH was performed. For patients with repeated implantation failures, the implantation rate in those who received laser-thinned embryos was significantly higher (P=0.02) than in those whose embryos were not laser-thinned (10.9 and 2.6% respectively). However, this difference was not observed in patients who presented with only one previous implantation failure. The data demonstrate that qLZT-AH is an effective strategy for improving the implantation of embryos in patients with repeated implantation failures.

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Alkaline materials have shown incompatibility with methylene blue dye in leakage experiments. The goal of the present study was to analyze the effect of different dyes on the evaluation of the apical sealing ability of Mineral Trioxide Aggregate root-end fillings. Fifty-six extracted human canines were submitted to root canal instrumentation and obturation. After apical resection, retrograde cavities were prepared and teeth were randomly divided into four experimental (n = 13) and two control groups (n = 2). The following root-end filling materials were used: groups 1 and 2--Pro Root MTA (Dentsply), groups 3 and 4--zinc oxide-eugenol cement (ZOE). Teeth in groups 1 and 3 were immersed in 2% methylene blue solution, while teeth in groups 2 and 4 were immersed in 0.2% rhodamine B in a reduced pressure environment for 48 hours. Teeth were then longitudinally sectioned and leakage was evaluated. Results were submitted to statistical analysis (ANOVA and Tukey's test). Group 1 presented the least leakage (p < 0.05). It was concluded that the evaluation of the sealing ability of MTA is influenced by the dye used, since this material presented better sealing ability when evaluated with Methylene Blue, but was similar to ZOE when evaluated with rhodamine B.