Hydroxyapatite/beta-tricalcium phosphate and enamel matrix derivative for treatment of proximal class II furcation defects: a randomized clinical trial

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

Release of Bone Markers in Immediately Loaded and Nonloaded Dental Implants: A Randomized Clinical Trial

The aim of this study was to compare the release of bone markers during osseointegration of immediately loaded and nonloaded implants. Forty patients who were indicated for rehabilitation with dental implants randomly received either implant and prosthesis placement within 72 hours (group IM) or implant insertion and no prosthesis placement (group NL). Peri-implant crevicular fluid was collected immediately after implant insertion and 7, 15, 30, 60, 90, and 120 days after surgery and levels of osteoprotegerin, transforming growth factors, osteocalcin, osteopontin, and parathyroid hormone were evaluated using Luminex assay. Bleeding index and peri-implantar sulcus depth were also evaluated. The data were compared using statistical tests ( = 5%). No statistical difference was found regarding demographic and clinical parameters (p > .05). Transforming growth factors, osteoprotegerin, osteopontin, and parathyroid hormone presented an earlier release peak in group IM than in NL group (p < .05). Osteocalcin achieved higher levels in group IM versus group NL between 7 and 30 days of evaluation (p < .05). It may be concluded that earlier loading positively modulates bone mediators release around immediately loaded implants when compared with nonloaded dental implants (ClinicalTrials.gov NCT01909999).

Evaluation of different treatment methods against denture stomatitis: a randomized clinical study

Objective. The aim of this clinical study was to determine the efficacy of Uncaria tomentosa (cat's claw) against denture stomatitis (DS).Study Design. Fifty patients with DS were randomly assigned into 3 groups to receive 2% miconazole, placebo, or 2% U tomentosa gel. DS level was recorded immediately, after 1 week of treatment, and 1 week after treatment. The clinical effectiveness of each treatment was measured using Newton's criteria. Mycologic samples from palatal mucosa and prosthesis were obtained to determinate colony forming units per milliliter (CFU/mL) and fungal identification at each evaluation period.Results. Candida species were identified with HiCrome Candida and API 20C AUX biochemical test. DS severity decreased in all groups (P < .05). A significant reduction in number of CFU/mL after 1 week (P < .05) was observed for all groups and remained after 14 days (P > .05). C albicans was the most prevalent microorganism before treatment, followed by C tropicalis, C glabrata, and C krusei, regardless of the group and time evaluated. U tomentosa gel had the same effect as 2% miconazole gel.Conclusions. U tomentosa gel is an effective topical adjuvant treatment for denture stomatitis.

Low Concentration H2O2/TiO_N in Office Bleaching: A Randomized Clinical Trial

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

A split-mouth randomized clinical trial of conventional and heavy flowable composites in class II restorations

Objective: The aim of this study was to evaluate the 2-year clinical performance of class II restorations made with a composite resin with two different viscosities.Methods: 47 patients received two class II restorations (n = 94), one made with GrandioSO (conventional viscosity CV), and the other with GrandioSO Heavy Flow (flowable viscosity FV), subjecting both materials to the same clinical conditions. The self-etching adhesive Futurabond M was used for all restorations. The composites were inserted using the incremental technique. The restorations were evaluated using the modified USPHS criteria according to the periods: baseline, 6 months, 1 year and 2 years after restorative procedures.Results: After 24 months, 40 patients attended the recall and 78 restorations were evaluated. In all periods, no secondary caries was observed. After 6 months, there were slightly overall changes of scores for most parameters. After 24 months, the higher number of changes from score Alfa to Bravo was observed for marginal discolouration (32.5% CV and 39.5% FV) and colour match (15% CV and 31.6% FV), followed by proximal contact (25% CV and 23.7% FV) and marginal adaptation (20% CV and 21.1% FV). For wear, surface texture and postoperative sensitivity the changes were very small. Just two restorations were lost during the 24-month follow up. Less than 5% of all restorations showed postoperative sensitivity. Chi-square test showed no significant differences between the two materials for all parameters analysed.Conclusion: After 2 years of clinical service, no significant differences were observed between GrandioSO conventional and GrandioSO Heavy Flow for the parameters analysed. Both materials provided acceptable clinical behaviour in class II restorations. Clinical Significance: This study presents the possibility of using a flowable composite with high filler content, for performing class II restorations. (C) 2014 Elsevier Ltd. All rights reserved.

The effects of elastic tubing-based resistance training compared with conventional resistance training in patients with moderate chronic obstructive pulmonary disease: a randomized clinical trial

Objective: To investigate the effects of elastic tubing training compared with conventional resistance training on the improvement of functional exercise capacity, muscle strength, fat-free mass, and systemic inflammation in patients with chronic obstructive pulmonary disease.Design: A prospective, randomized, eight-week clinical trial.Setting: The study was conducted in a university-based, outpatient, physical therapy clinic.Subjects: A total of 49 patients with moderate chronic obstructive pulmonary disease.Interventions: Participants were randomly assigned to perform elastic tubing training or conventional resistance training three times per week for eight weeks.Main measures: The primary outcome measure was functional exercise capacity. The secondary outcome measures were peripheral muscle strength, health-related quality of life assessed by the Chronic Respiratory Disease Questionnaire (CRDQ), fat-free mass, and cytokine profile.Results: After eight weeks, the mean distance covered during six minutes increased by 73 meters (69) in the elastic tubing group and by 42 meters (+/- 59) in the conventional group (p < 0.05). The muscle strength and quality of life improved in both groups (P < 0.05), with no significant differences between the groups. There was a trend toward an improved fat-free mass in both groups (P = 0.05). After the first and last sessions, there was an increase in interleukin 1 (IL-1) and interleukin 10 (IL-10) in both groups, while tumour necrosis factor alpha (TNF-) was stimulated only in the conventional training group.Conclusion: Elastic tubing training had a greater effect on functional exercise capacity than conventional resistance training. Both interventions were equally effective in improving muscle strength and quality of life.

Longitudinal effect of curcumin-photodynamic antimicrobial chemotherapy in adolescents during fixed orthodontic treatment: a single-blind randomized clinical trial study

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

Masticatory performance of complete denture wearers after using two adhesives: a crossover randomized clinical trial

Statement of problem Masticatory performance analysis of conventional complete denture wearers who use denture adhesives is scarce in the dental literature. Purpose The purpose of this study was to assess the effect of the use of 2 denture adhesives on the masticatory performance of conventional complete denture wearers by means of a crossover study. Material and methods Forty individuals who were edentulous received new maxillary and mandibular complete dentures, and, after an adaptation period, were submitted to masticatory performance analysis without denture adhesive (control). The participants were randomly divided and assigned to 2 protocols: protocol 1, denture adhesive 1 (Ultra Corega cream tasteless) use during the first 15 days, followed by no use of denture adhesive over the next 15 days (washout), and then use of denture adhesive 2 (Ultra Corega powder tasteless) for 15 days; protocol 2, denture adhesive 2 (Ultra Corega powder tasteless) use during the first 15 days, followed by no use of denture adhesive during the next 15 days (washout), and then use of denture adhesive 1 (Ultra Corega cream tasteless) for 15 days. The masticatory performance was assessed immediately after the use of denture adhesive by means of the sieve method, in which participants were instructed to deliberately chew 5 almonds for 20 chewing strokes. Masticatory performance was calculated by the weight of comminuted material that passed through the sieves. Data were analyzed by a 1-way ANOVA for paired samples and the multiple comparison of means by using the Bonferroni test (α=.05). Results A significant increase in masticatory performance was noted after using the Ultra Corega cream (mean, 32.6%) and Ultra Corega powder (mean, 31.2%) when compared with the control group (mean, 19.8%) (P<.001). No significant difference was found between the 2 denture adhesives evaluated. Conclusion The use of denture adhesive improved the masticatory performance of conventional complete denture wearers. No difference was found in masticatory performance with the use of cream or powder denture adhesive.

Effect of a Denture Adhesive on the Satisfaction and Kinesiographic Parameters of Complete Denture Wearers: A Cross-Over Randomized Clinical Trial

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Recovering Streptococcus mutans over restorations by the tray technique: a randomized clinical study

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Dialysis complications in acute kidney injury patients treated with prolonged intermittent renal replacement therapy sessions lasting 10 versus 6 hours: results of a randomized clinical trial

Prolonged intermittent renal replacement therapy (PIRRT) has emerged as an alternative to continuous renal replacement therapy in the management of acute kidney injury (AKI) patients. This trial aimed to compare the dialysis complications occurring during different durations of PIRRT sessions in critically ill AKI patients. We included patients older than 18 years with AKI associated with sepsis admitted to the intensive care unit and using noradrenaline doses ranging from 0.3 to 0.7 mu g/kg/min. Patients were divided into two groups randomly: in G1, 6-h sessions were performed, and in G2, 10-h sessions were performed. Seventy-five patients were treated with 195 PIRRT sessions for 18 consecutive months. The prevalence of hypotension, filter clotting, hypokalemia, and hypophosphatemia was 82.6, 25.3, 20, and 10.6%, respectively. G1 was composed of 38 patients treated with 100 sessions, whereas G2 consisted of 37 patients treated with 95 sessions. G1 and G2 were similar in male predominance (65.7 vs. 75.6%, P=0.34), age (63.6 +/- 14 vs. 59.9 +/- 15.5 years, P=0.28) and Sequential Organ Failure Assessment score (SOFA; 13.1 +/- 2.4 vs. 14.2 +/- 3.0, P=0.2). There was no significant difference between the two groups in hypotension (81.5 vs. 83.7%, P=0.8), filter clotting (23.6 vs. 27%, P=0.73), hypokalemia (13.1 vs. 8.1%, P=0.71), and hypophosphatemia (18.4 vs. 21.6%, P=0.72). However, the group treated with sessions of 10h were refractory to clinical measures for hypotension, and dialysis sessions were interrupted more often (9.5 vs. 30.1%, P=0.03). Metabolic control and fluid balance were similar between G1 and G2 (blood urea nitrogen [BUN]: 81 +/- 30 vs. 73 +/- 33mg/dL, P=1.0; delivered Kt/V: 1.09 +/- 0.24 vs. 1.26 +/- 0.26, P=0.09; actual ultrafiltration: 1731 +/- 818 vs. 2332 +/- 947mL, P=0.13) and fluid balance (-731 +/- 125 vs. -652 +/- 141mL, respectively) . In conclusion, intradialysis hypotension was common in AKI patients treated with PIRRT. There was no difference in the prevalence of dialysis complications in patients undergoing different durations of PIRRT.

Comparison between noninvasive mechanical ventilation and standard oxygen therapy in children up to 3 years old with respiratory failure after extubation: a pilot prospective randomized clinical study

Objectives: The effectiveness of noninvasive positive-pressure ventilation in preventing reintubation due to respiratory failure in children remains uncertain. A pilot study was designed to evaluate the frequency of extubation failure, develop a randomization approach, and analyze the feasibility of a powered randomized trial to compare noninvasive positive-pressure ventilation and standard oxygen therapy post extubation for preventing reintubation within 48 hours in children with respiratory failure.Design: Prospective pilot study.Setting: PICU at a university-affiliated hospital.Patients: Children aged between 28 days and 3 years undergoing invasive mechanical ventilation for greater than or equal to 48 hours with respiratory failure after programmed extubation.Interventions: Patients were prospectively enrolled and randomly assigned into noninvasive positive-pressure ventilation group and inhaled oxygen group after programmed extubation from May 2012 to May 2013.Measurements and Main Results: Length of stay in PICU and hospital, oxygenation index, blood gas before and after tracheal extubation, failure and reason for tracheal extubation, complications, mechanical ventilation variables before tracheal extubation, arterial blood gas, and respiratory and heart rates before and 1 hour after tracheal extubation were analyzed. One hundred eight patients were included (noninvasive positive-pressure ventilation group, n = 55 and inhaled oxygen group, n = 53), with 66 exclusions. Groups did not significantly differ for gender, age, disease severity, Pediatric Risk of Mortality at admission, tracheal intubation, and mechanical ventilation indications. There was no statistically significant difference in reintubation rate (noninvasive positive-pressure ventilation group, 9.1%; inhaled oxygen group, 11.3%; p > 0.05) and length of stay (days) in PICU (noninvasive positive-pressure ventilation group, 3 [116]; inhaled oxygen group, 2 [1-25]; p > 0.05) or hospital (noninvasive positive-pressure ventilation group, 19 [7-141]; inhaled oxygen group, 17 [8-80]).Conclusions: The study indicates that a larger randomized trial comparing noninvasive positive-pressure ventilation and standard oxygen therapy in children with respiratory failure is feasible, providing a basis for a future trial in this setting. No differences were seen between groups. The number of excluded patients was high.

Connective tissue graft associated or not with low laser therapy to treat gingival recession: randomized clinical trial

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

Masticatory performance of complete denture wearers after using two adhesives: a crossover randomized clinical trial

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

Perception of the informed consent form by participants in clinical trials

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.