Sealing composite with defective margins, good care or over treatment? results of a 10-year clinical trial

Purpose: The objective of this study was to clinically evaluate sealed composite restorations after 10 years and compare their behavior with respect to controls. Methods and Materials: The cohort consisted of 20 patients aged 18 to 80 years with 80 composite restorations. All participants in the sealing and no-treatment groups presented with clinical features for the marginal adaptation that deviated from the ideal and were rated Bravo (United States Public Health Service criteria). Composites with Alfa values for the marginal adaptation were used as the positive control. Results: The marginal adaptation behavior was similar between the sealing and control (+) groups, with a high frequency of Bravo values in the 10th year (80% and 51%, respectively). Most of the no-treatment (-) group maintained the Bravo values (91%) for 10 years, although some restorations (9%) progressed to Charlie values. The anatomy parameter differed significantly between the first and 10th years, with deterioration in all three groups (p,0.05). The secondary caries parameter had a similar behavior in the three groups (p.0.05). Conclusions: Sealing the margins of the composite resin restorations had no significant effect compared with the control groups, under the conditions of this study. Sealing the restorations substantially improved the marginal staining and marginal adaptation parameters, although by the tenth year they were similar to the group without intervention.

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)

A randomised controlled trial of periconal eye blockade with or without ultrasound guidance

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

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.

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)

Longer immediate recovery time after anesthesia increases risk of respiratory complications after laparotomy for bariatric surgery: a randomized clinical trial and a cohort study

We compared the effects of two anesthesia protocols in both immediate recovery time (IRT) and postoperative respiratory complications (PRCs) after laparotomy for bariatric surgery, and we determined the association between the longer IRT and the increase of PRC incidence. We conducted the study in two stages: (i) in a randomized controlled trial (RCT), patients received either intervention (sevoflurane-remifentanil-rocuronium-ropivacaine) or control protocol (isoflurane-sufentanil-atracurium-levobupivacaine). All patients received general anesthesia plus continuous epidural anesthesia and analgesia. Treatment was masked for all, except the provider anesthesiologist. We defined IRT as time since anesthetics discontinuation until tracheal extubation. Primary outcomes were IRT and PRCs incidence within 15 days after surgery. We also analyzed post-anesthesia care unit (PACU) and hospital length of stays; (ii) after the end of the RCT, we used the available data in an extension cohort study to investigate IRT > 20 min as exposure factor for PRCs. Control protocol (n = 152) resulted in longer IRT (30.4 ± 7.9 vs 18.2 ± 9.6 min; p < 0.0001), higher incidence of PRCs (6.58 vs 2.5 %; p = 0.048), and longer PACU and hospital stays than intervention protocol (n = 200); PRC relative risk (RR) = 2.6. Patients with IRT > 20 min (n = 190) presented higher incidence of PRCs (7.37 vs 0.62 %; p < 0.0001); RR = 12.06. Intervention protocol, with short-acting anesthetics, was more beneficial and safe compared to control protocol, with long-acting drugs, regarding the reduction of IRT, PRCs, and PACU and hospital stays for laparotomy in bariatric patients. We identified a 4.5-fold increase in the relative risk of PRCs when morbid obese patients are exposed to an IRT > 20 min.

Effect of vitamin D supplementation alone on muscle function in postmenopausal women: a randomized, double-blind, placebo-controlled clinical trial

The present study investigates the effects of vitamin D on muscle function in postmenopausal women. It has been shown that vitamin D supplementation in postmenopausal women with hypovitaminosis D provides significant protective factor against sarcopenia, with significant increases in muscle strength and control of progressive loss of lean mass. We aimed to evaluate the effect of supplementation of vitamin D (VITD) alone on muscle function in younger postmenopausal women. In this double-blind, placebo-controlled clinical trial, 160 Brazilian postmenopausal women were randomized into two groups: VITD group consisting of patients receiving vitamin D3 1000 IU/day orally (n = 80) or placebo group (n = 80). Women with amenorrhea for more than 12 months and age 50-65 years, with a history of falls (previous 12 months), were included. The intervention time was 9 months, with assessments at two points, start and end. Lean mass was estimated by total-body dual-energy X-ray absorptiometry (DXA) and muscle strength by handgrip strength and chair rising test. The plasma concentrations of 25-hydroxyvitamin D [25(OH)D] were measured by high-performance liquid chromatography (HPLC). Statistical analysis was by intention to treat (ITT), using ANOVA, Student's t test, and Tukey's test. After 9 months, average values of 25(OH)D increased from 15.0 ± 7.5 to 27.5 ± 10.4 ng/ml (+45.4 %) in the VITD group and decreased from 16.9 ± 6.7 to 13.8 ± 6.0 ng/ml (-18.5 %) in the placebo group (p < 0.001). In the VITD group, there was significant increase in muscle strength (+25.3 %) of the lower limbs by chair rising test (p = 0.036). In women in the placebo group, there was considerable loss (-6.8 %) in the lean mass (p = 0.030). The supplementation of vitamin D alone in postmenopausal women provided significant protective factor against the occurrence of sarcopenia, with significant increases in muscle strength and control of progressive loss of lean mass.

Effectiveness of 6% hydrogen peroxide concentration for tooth bleaching-A double-blind, randomized clinical trial

The aim of this clinical randomized double-blind split-mouth study was to assess the effectiveness of a 6% hydrogen peroxide with nitrogen-doped titanium dioxide light activated bleaching agent. 31 patients were treated with: one upper hemiarcade with a 35% hydrogen peroxide bleaching agent and the other hemiarcade with a 6% hydrogen peroxide. Two applications were completed each treatment session and three sessions were appointed, with one week interval between them. Tooth colour was registered each session and 1 week and 1 months after completing the treatment by spectrophotometer, registering parameters L*, a* and b*, and subjectively using VITA Classic guide. Tooth sensitivity was registered by VAS and patient satisfaction and self-perception result was determined using OHIP-14. Tooth colour variation and sensitivity were compared between both bleaching agents. Both treatment showed a change between baseline colour and all check-points with a ΔE=5.57 for 6% and of ΔE=7.98 for the 35% one month after completing the (p<0.05). No statistical differences were seen when subjective evaluations were compared. Also, no differences were seen in tooth sensitivity between bleaching agents. OHIP-14 questionnaire demonstrated a significant change for all patients after bleaching. A 6% hydrogen peroxide with nitrogen-doped titanium dioxide light activated agent is effective for tooth bleaching, reaching a ΔE of 5.57 one month after completing the treatment, with no clinical differences to a 35% agent neither in colour change or in tooth sensitivity. A low concentration hydrogen peroxide bleaching agent may reach good clinical results with less adverse effects.

Effect of GaAIAs low-level laser therapy on the healing of human palate mucosa after connective tissue graft harvesting: randomized clinical trial

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

Seal, replacement or monitoring amalgam restorations with occlusal marginal defects? Results of a 10-year clinical trial

The aim of this prospective and blind clinical trial was to assess the effectiveness of sealing localized marginal defects of amalgam restoration that were initially scheduled to be replaced. A cohort of twenty six patients with 60 amalgam restorations (n=44Class I and n=16Class II), that presented marginal defects deviating from ideal (Bravo) according to USPHS criteria, were assigned to either sealing or replacement groups: A: sealing n=20, Replacement n=20, and no treatment (n=20). Two blind examiners evaluated the restorations at baseline (K=0.74) and after ten years (K=0.84) according with USPHS criteria, in four parameters: marginal adaptation (MA), secondary caries (SC), marginal staining (MS) and teeth sensitivity (TS). Multiple comparison of restorations degradation/upgrade was analyzed by Friedman test and the comparisons within groups were performed by Wilcoxon test. After 10 years, 44 restorations were assessed (73.3%), Group A: n=14 and Group B: n=16; and Group C: n=14 sealing and replacement amalgam restorations presented similar level of quality in MA (p=0.76), SC (p=0.25) and TS (p=0.52), while in MS (p=0.007) presented better performance in replacement group after 10-years. Most of the occlusal amalgam restorations with marginal gaps showed similar long term outcomes than the restorations were sealed, replaced, or not treated over a 10-year period. Most of the restorations of the three groups were clinically acceptable, under the studied parameters. All restorations had the tendency to present downgrade/deterioration over time.

Re-treatment of previous non-responders and relapsers to interferon plus ribavirin with peginterferon alfa-2a (40KD), ribavirin +/- amantadine in patients with chronic hepatitis C: randomized multicentre clinical trial

Introduction. A large number of patients with chronic hepatitis C have not been cured with interferon-based therapy. Therefore, we evaluated the efficacy of amantadine combined with the standard of care (pegylated interferon plus ribavirin) in patients who had not responded to or had relapsed after 24 weeks of treatment with conventional interferon plus ribavirin. Material and methods. Patients stratified by previous response (i.e., non-response or relapse) were randomized to 48 weeks of open-label treatment with peginterferon alfa-2a (401(D) 180 pg/week plus ribavirin 1,000/1,200 mg/day plus amantadine 200 mg/day (triple therapy), or the standard of care (peginterferon alfa-2a [40KD] plus ribavirin). Results. The primary outcome was sustained virological response (SVR), defined as undetectable hepatitis C virus RNA in serum (< 50 IU/mL) at end of follow-up (week 72). Among patients with a previous non-response, 12/53 (22.6%; 95% confidence interval [CI] 12.3-36.2%) randomized to triple therapy achieved an SVR compared with 16/52 (30.8%; 95% CI 18.7-45.1%) randomized to the standard of care. Among patients with a previous relapse 22/39 (56.4%; 95% CI 39.6-72.2%) randomized to triple therapy achieved an SVR compared with 23/38 (60.5%; 95% CI 43.4-76.0%) randomized to the standard of care. Undetectable HCV RNA (< 50 IU/mL) at week 12 had a high positive predictive value for SVR. A substantial proportion of non-responders and relapsers to conventional interferon plus ribavirin achieve an SVR when re-treated with peginterferon alfa-2a (40KD) plus ribavirin. Conclusion. Amantadine does not enhance SVR rates in previously treated patients with chronic hepatitis C and cannot be recommended in this setting.

Clinical trial design in non-invasive brain stimulation psychiatric research

Major depressive disorder (MDD) trials - investigating either non-pharmacological or pharmacological interventions - have shown mixed results. Many reasons explain this heterogeneity, but one that stands out is the trial design due to specific challenges in the field. We aimed therefore to review the methodology of non-invasive brain stimulation (NIBS) trials and provide a framework to improve clinical trial design. We performed a systematic review for randomized, controlled MDD trials whose intervention was transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) in MEDLINE and other databases from April 2002 to April 2008. We created an unstructured checklist based on CONSORT guidelines to extract items such as power analysis, sham method, blinding assessment, allocation concealment, operational criteria used for MDD, definition of refractory depression and primary study hypotheses. Thirty-one studies were included. We found that the main methodological issues can be divided in to three groups: (1) issues related to phase II/small trials, (2) issues related to MDD trials and, (3) specific issues of NIBS studies. Taken together, they can threaten study validity and lead to inconclusive results. Feasible solutions include: estimating the sample size a priori; measuring the degree of refractoriness of the subjects; specifying the primary hypothesis and statistical tests; controlling predictor variables through stratification randomization methods or using strict eligibility criteria; adjusting the study design to the target population; using adaptive designs and exploring NIBS efficacy employing biological markers. In conclusion, our study summarizes the main methodological issues of NIBS trials and proposes a number of alternatives to manage them. Copyright (C) 2011 John Wiley & Sons, Ltd.

Gray Matter Volumes in Obsessive-Compulsive Disorder Before and After Fluoxetine or Cognitive-Behavior Therapy: A Randomized Clinical Trial

Serotonin reuptake inhibitors and cognitive-behavior therapy (CBT) are considered first-line treatments for obsessive-compulsive disorder (OCD). However, little is known about their modulatory effects on regional brain morphology in OCD patients. We sought to document structural brain abnormalities in treatment-naive OCD patients and to determine the effects of pharmacological and cognitive-behavioral treatments on regional brain volumes. Treatment-naive patients with OCD (n = 38) underwent structural magnetic resonance imaging scan before and after a 12-week randomized clinical trial with either fluoxetine or group CBT. Matched-healthy controls (n = 36) were also scanned at baseline. Voxel-based morphometry was used to compare regional gray matter (GM) volumes of regions of interest (ROIs) placed in the orbitofrontal, anterior cingulate and temporolimbic cortices, striatum, and thalamus. Treatment-naive OCD patients presented smaller GM volume in the left putamen, bilateral medial orbitofrontal, and left anterior cingulate cortices than did controls (p<0.05, corrected for multiple comparisons). After treatment with either fluoxetine or CBT (n = 26), GM volume abnormalities in the left putamen were no longer detectable relative to controls. ROI-based within-group comparisons revealed that GM volume in the left putamen significantly increased (p<0.012) in fluoxetine-treated patients (n = 13), whereas no significant GM volume changes were observed in CBT-treated patients (n = 13). This study supports the involvement of orbitofronto/cingulo-striatal loops in the pathophysiology of OCD and suggests that fluoxetine and CBT may have distinct neurobiological mechanisms of action. Neuropsychopharmacology (2012) 37, 734-745; doi: 10.1038/npp.2011.250; published online 26 October 2011

Clinical Effects of Scalp Electrical Acupuncture in Stroke: A Sham-Controlled Randomized Clinical Trial

Objectives: The majority of individuals who survive a stroke are disabled because of persisting neurological impairments. The objective of this study was to evaluate the efficacy of subcutaneous electrical stimulation of the scalp in spontaneous functional recovery of patients with chronic ischemic stroke, by evaluating clinical, neurological, and functional findings. Subjects and methods: Sixty-two (62) subjects who were at least 18 months postdiagnosis of ischemic stroke were randomized to receive 10 sessions of placebo or active low-frequency electrical stimulation (2/100 Hz) using subcutaneous acupuncture needles over the scalp. Functional and neurological evaluations were indexed by the Barthel, Rankin, and National Institutes of Health Stroke Scale (NIHSS). Results: Results show that there was a significant difference in functional improvement between the sham and active group as indexed by NIHSS scale. The active group had a larger functional improvement after 10 sessions of scalp electrical acupuncture. The other two functional scales (Rankin and Barthel) failed to show significant differences between the two treatment groups. Conclusions: These results support further testing of scalp electrical acupuncture for the treatment of stroke as well further mechanistic studies to understand mechanisms associated with the observed improvement. Further studies need to consider longer follow-up assessments to investigate potential functional changes associated with electrical acupuncture.