96 resultados para clinical trial


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Objective: The aim of this study was to evaluate the 5-year clinical performance of composite restorations of non-carious cervical lesions (NCCL) using a total-etch adhesive system with or without collagen removal with 10% sodium hypochlorite (NaOCl).Methods: In this study randomized controlled split-mouth clinical trial, one-hundred and thirty-eight NCCL were restored into 30 patients. Each patient received at least one pair of composite restorations (Filtek A110/3M ESPE), bonded either with 2 techniques: Conventional Technique - acid etching with 37% phosphoric acid + Prime & Bond NT (Denstply DeTrey); Deproteinization Technique - acid etching with 37% phosphoric acid + 10% NaOCl for 1 min + Prime & Bond NT. The two techniques were evaluated using the United States Public Health Service (USPHS) criteria at baseline, 18 months, 3 and 5 years. After five years, one-hundred and six restorations were evaluated in 24 patients. Data were analyzed using the Chi-Square test (p < 0.05).Results: There were no statistically significant differences between the two techniques regarding the evaluated parameters (p > 0.05).Conclusion: After 5 years, the application of 10% NaOCl deproteinization on etched dentine did not affect the clinical performance of composite restorations placed in NCCL when compared to the conventional total-etch technique.Clinical significance: Clinical studies evaluating the performance of the Deproteinization Technique are scarce. In this study, this technique showed similar clinical performance at the end of 5 years when compared to a conventional total-etch technique. (C) 2014 Elsevier Ltd. All rights reserved.

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Background: The management of aggressive periodontitis (AgP) represents a challenge for clinicians because there are no standardized protocols for an efficient control of the disease. This randomized controlled clinical trial evaluated the effects of repeated applications of antimicrobial photodynamic therapy (aPDT) adjunctive to scaling and root planing (SRP) in patients with AgP. Methods: Using a split-mouth design, 20 patients with generalized AgP were treated with aPDT + SRP (test group) or SRP only (control group). aPDT was applied at four periods. All patients were monitored for 90 days. Clinical, microbiologic, and immunologic parameters were statistically analyzed. Results: In deep periodontal pocket analysis (probing depth [PD] >= 7 mm at baseline), the test group presented a decrease in PD and a clinical attachment gain significantly higher than the control group at 90 days (P < 0.05). The test group also demonstrated significantly less periodontal pathogens of red and orange complexes and a lower interleukin-1 beta/interleukin-10 ratio than the control group (P < 0.05). Conclusion: The application of four sessions of aPDT, adjunctive to SRP, promotes additional clinical, microbiologic, and immunologic benefits in the treatment of deep periodontal pockets in single-rooted teeth in patients with AgP.

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To understand the perception of the participants in controlled clinical trials (CCTs) about the informed consent and describe the meaning of their participation in the research. Qualitative study using the focus group technique. The sample was composed of 19 patients who participated in clinical trials about hypertension and coronary disease in a specialized cardiologic hospital located in the city of Sao Paulo. The methodological framework used was the content analysis. Some of the participants were aware of the real objective of these studies while others had misperceptions. The reading of the informed consent is not always done and, when it is done, the patient does not understand it. The lack of understanding about the term ''placebo'' was mentioned by some participants. The motivation to participate was the personal benefit. This study shows that obtaining the informed consent in CCTs is complex and that there is the need to adapt the structure and application of this document, in order to protect the participants and improve the quality of clinical trials performed in the country.

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Insulin resistance is a common risk factor in chronic kidney disease patients contributing to the high cardiovascular burden, even in the absence of diabetes. Glucose-based peritoneal dialysis (PD) solutions are thought to intensify insulin resistance due to the continuous glucose absorption from the peritoneal cavity. The aim of our study was to analyse the effect of the substitution of glucose for icodextrin on insulin resistance in non-diabetic PD patients in a multicentric randomized clinical trial. This was a multicenter, open-label study with balanced randomization (1:1) and two parallel-groups. Inclusion criteria were non-diabetic adult patients on automated peritoneal dialysis (APD) for at least 3 months on therapy prior to randomization. Patients assigned to the intervention group were treated with 2L of icodextrin 7.5%, and the control group with glucose 2.5% during the long dwell and, at night in the cycler, with a prescription of standard glucose-based PD solution only in both groups. The primary end-point was the change in insulin resistance measured by homeostatic model assessment (HOMA) index at 90 days. Sixty patients were included in the intervention (n = 33) or the control (n = 27) groups. There was no difference between groups at baseline. After adjustment for pre-intervention HOMA index levels, the group treated with icodextrin had the lower post-intervention levels at 90 days in both intention to treat [1.49 (95% CI: 1.23-1.74) versus 1.89 (95% CI: 1.62-2.17)], (F = 4.643, P = 0.03, partial η(2) = 0.078); and the treated analysis [1.47 (95% CI: 1.01-1.84) versus 2.18 (95% CI: 1.81-2.55)], (F = 7.488, P = 0.01, partial η(2) = 0.195). The substitution of glucose for icodextrin for the long dwell improved insulin resistance measured by HOMA index in non-diabetic APD patients.

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Context: The possibility of bleaching vital teeth with peroxide-based products considerably revolutionized esthetic dentistry. Aim: The aim of this clinical study was to evaluate tooth color change and dental sensitivity after exposure to preloaded film containing a 10% hydrogen peroxide whitening system (Opalescence Trθswhite Supreme). Materials and Methods: A total of 13 volunteers, aged 18 to 25 years, participated in this study. The patients used the whitening system once a day for 60 minutes during the 8-day study. For maxillary incisors and canines, the color change was visually evaluated with the Vita color scale before, immediately, and six months after the treatment. Tooth sensitivity was evaluated during the daily gel applications. All whitening applications were done in office and under the supervision of a dental professional. Statistical Analysis Used: The results were analyzed using the Friedman Test (nonparametric repeated measures ANOVA) at a level of 5%, and Dunn's Multiple Comparison Test at the level of 5%. Results: It was verified that the original mean color values observed at the baseline analysis differed significantly from those observed immediately after bleaching, as well as from those seen in the analysis at six months ( P = 0.001). There was no significant difference between the mean color values observed in the immediate time and in the analysis at six months ( P = 0.474). No tooth sensitivity was observed in any patients. Conclusion: It was concluded that the bleaching technique using the 10% hydrogen peroxide system was effective in a short period of time without tooth sensitivity during applications.

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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)