Dentin hypersensitivity after teeth bleaching with in-office systems. randomized clinical trial

Purpose: To comparatively and prospectively compare in a randomized clinical trial, dentin hypersensitivity after treatment with three in-office bleaching systems, based on hydrogen peroxide at different concentrations, with and without light source activation. Methods: 88 individuals were included according to inclusion and exclusion criteria. Subjects were randomly divided into the following three treatment groups: Group 1 was treated with three 15-minute applications of hydrogen peroxide at 15% with titanium dioxide (Lase Peroxide Lite) that was light-activated (Light Plus Whitening Lase) with five cycles of 1 minute and 30 seconds each cycle, giving a total treatment time of 45 minutes; Group 2 was treated with three 10-minute applications of hydrogen peroxide at 35% (Lase Peroxide Sensy), activated by light (LPWL) same activation cycles than Group 1, with a total treatment time of 30 minutes; Group 3 was treated with only one application for 45 minutes of hydrogen peroxide at 35% (Whitegold Office) without light activation. Each subject underwent one session of bleaching on the anterior teeth according to the manufacturers' instructions. Dentin sensitivity was recorded with a visual analogue scale (VAS) at baseline, immediately after, and at 7 and 30 days after treatment using a stimulus of an evaporative blowing triple syringe for 3 seconds on the upper central incisors from a distance of 1 cm. A Kruskal-Wallis test followed by Mann-Whitney test was performed for statistical analysis. Results: All groups showed increased sensitivity immediately after treatment. Group 1 displayed less changes relative to baseline with no significant differences (P= 0.104). At 7 and 30 days after treatment, a comparison of VAS values indicated no significant differences between all groups (P= 0.598 and 0.489, respectively).

Modified radical mastectomy: A pilot clinical trial comparing the use of conventional electric scalpel and harmonic scalpel

Background: The aim of this study was to compare the rates of local postoperative complications among women undergoing modified radical mastectomy with an electric scalpel (ES) or a harmonic scalpel (HS). It is thought that HS use has less postoperative complications, mainly seroma formation. Methods: This study was a prospective non-randomised clinical trial (NCT01391988) among consecutive patients, performed in parallel. Patients underwent modified radical mastectomy using an HS or ES. We analysed the following operative variables: time, blood loss and seroma volume drainage. Postoperative complications, including seroma, flap necrosis, haematoma and infection were evaluated on the 7th and 14th days. Results: Forty-six patients underwent a MRM with ES and 49 with HS; no differences were observed between the groups. The rate of local complications was 29% in the HS group and 52% in the ES group (p=0.024). The rates of seroma (16.3% versus 28.3%; p=0.161), necrosis (4.1% vs. 21.7%; p=0.013; OR=0.15), haematoma (2.0% vs. 8.7%; p=0.195) and infection (2.0% vs. 6.5%; p=0.351) were lower in the HS group. Adding the findings of all comparative studies using HSs in MRM to the seroma rates in the current study, the seroma rate, expressed as a categorical variable, did not decrease with HS. Seroma was present in 60/219 cases using an HS and in 69/239 cases utilising an ES (p=0.72). Based on a multivariate analysis, HS decreased the risk of skin necrosis (p=0.015). Conclusions: HSs do not decrease the seroma rate. However, this method may be useful in skin sparing mastectomy because it decreases skin flap necrosis. © 2013 Surgical Associates Ltd.

A randomized clinical trial of high volume peritoneal dialysis versus extended daily hemodialysis for acute kidney injury patients

Background: Acute kidney injury (AKI) requiring dialysis in critically ill patients is associated with an in-hospital mortality rate of 50-80 %. Extended daily hemodialysis (EHD) and high volume peritoneal dialysis (HVPD) have emerged as alternative modalities. Methods: A double-center, randomized, controlled trial was conducted comparing EHD versus HVPD for the treatment for AKI in the intensive care unit (ICU). Four hundred and seven patients were randomized and 143 patients were analyzed. Principal outcome measure was hospital mortality, and secondary end points were recovery of renal function and metabolic and fluid control. Results: There was no difference between the two groups in relation to median ICU stay [11 (5.7-20) vs. 9 (5.7-19)], recovery of kidney function (26.9 vs. 29.6 %, p = 0.11), need for chronic dialysis (9.7 vs. 6.5 %, p = 0.23), and hospital mortality (63.4 vs. 63.9 %, p = 0.94). The groups were different in metabolic and fluid control. Blood urea nitrogen (BUN), creatinine, and bicarbonate levels were stabilized faster in EHD group than in HVPD group. Delivered Kt/V and ultrafiltration were higher in EHD group. Despite randomization, there were significant differences between the groups in some covariates, including age, pre-dialysis BUN, and creatinine levels, biased in favor of the EHD. Using logistic regression to adjust for the imbalances in group assignment, the odds of death associated with HVPD was 1.4 (95 % CI 0.7-2.4, p = 0.19). A detailed investigation of the randomization process failed to explain the marked differences in patient assignment. Conclusions: Despite faster metabolic control and higher dialysis dose and ultrafiltration with EHD, this study provides no evidence of a survival benefit of EHD compared with HVPD. The limitations of this study were that the results were not presented according to the intention to treat and it did not control other supportive management strategies as nutrition support and timing of dialysis initiation that might influence outcomes in AKI. © 2012 Springer Science+Business Media Dordrecht.

Randomized controlled clinical trial evaluating connective tissue graft plus resin-modified glass ionomer restoration for the treatment of gingival recession associated with non-carious cervical lesion: 2-year follow-up

Background: The aim of this clinical study is to evaluate the 2-year term results of gingival recession (GR) associated with non-carious cervical lesions (NCCLs) treated by connective tissue graft (CTG) alone or in combination with a resin-modified glass ionomer restoration (CTG+R). Methods: Thirty-six patients with Miller Class I buccal GR associated with NCCLs completed the follow-up. The defects were randomly assigned to receive either CTG or CTG+R. Bleeding on probing (BOP), probing depth (PD), relative GR, clinical attachment level (CAL), and cervical lesion height coverage were measured at baseline, 6 months, 1 year, and 2 years after treatment. Results: Both groups showed statistically significant gains in CAL and soft-tissue coverage. The differences between groups were not statistically significant in BOP, PD, relative GR, or CAL after 2 years. Cervical lesion height coverage was 79.31% ± 18.51% for CTG and 71.95% ± 13.25% for CTG+R (P >0.05). Estimated root coverage was 91.56% ± 11.74% for CTG and 93.29% ± 7.97% for CTG+R (P ≥0.05). Conclusions: Within the limits of the present study, it can be concluded that both procedures provide comparable soft tissue coverage after 2 years of follow-up.

Effects of soy isoflavones on mammographic density and breast parenchyma in postmenopausal women: A randomized, double-blind, placebo-controlled clinical trial

OBJECTIVE: This study aims to evaluate the effects of soy isoflavones on breast tissue in postmenopausal women. METHODS: In this randomized, double-blind, placebo-controlled study, 80 women (aged ≥45 y and with amenorrhea >12 mo) with vasomotor symptoms were randomized to receive either 250 mg of standardized soy extract corresponding to isoflavone 100 mg/day (n = 40) or placebo (n = 40) for 10 months. Breasts were evaluated through mammographic density and breast parenchyma using ultrasound (US) at baseline and 10-month follow-up. Independent t test, analysis of variance, Mann-Whitney U test, and χ2 trend test were used in statistical analysis. RESULTS: Baseline clinical characteristics showed no significant differences between the isoflavone group and the placebo group, with mean (SD) age of 55.1 (6.0) and 56.2 (7.7) years, mean (SD) menopause duration of 6.6 (4.8) and 7.1 (4.2) years, and mean (SD) body mass index of 29.7 (5.0) and 28.5 (4.9) kg/m2, respectively (P > 0.05). The study was completed by 32 women on isoflavone and 34 women on placebo. The groups did not differ in mammographic density or breast parenchyma by US (P > 0.05). Within each group, the baseline and final moments did not differ in mammography or US parameters significantly (P > 0.05). CONCLUSIONS: The use of soy isoflavone extract for 10 months does not affect breast density, as assessed by mammography and US, in postmenopausal women. © 2013 by The North American Menopause Society.

Horizontal ridge augmentation of the atrophic anterior maxilla using rhBMP-2/ACS or autogenous bone grafts: A proof-of-concept randomized clinical trial

Aim To compare the effect of recombinant human bone morphogenetic protein-2 (rhBMP-2) in an absorbable collagen sponge carrier (ACS) with autogenous bone graft for augmentation of the edentulous atrophic anterior maxilla. Methods Twenty-four subjects were enrolled in a randomized, controlled, parallel-group, open-label clinical trial. Subjects either received rhBMP-2/ACS (1.5 mg/ml) or particulated autogenous bone harvested from the mandibular retromolar region. A titanium-mesh was used to provide space and wound stability. A guide was used to standardize clinical recordings using an analogue caliper. Alveolar ridge width was also assessed using cone-beam computed tomography. Results rhBMP-2/ACS yielded significantly greater radiographic horizontal bone gain compared with autogenous bone graft at immediate subcrestal levels (1.5 ± 0.7 versus 0.5 ± 0.9 mm; p = 0.01); non-significant differences were observed at mid- (2.9 ± 0.8 versus 2.9 ± 0.9 mm; p = 0.98) and apical (1.7 ± 0.9 versus 1.8 ± 1.1 mm; p = 0.85) crestal levels. No significant differences in clinical horizontal bone gain were observed at 6 months between rhBMP-2/ACS and autogenous bone graft (3.2 ± 0.9 mm versus 3.7 ± 1.4 mm; p = 0.31). Sixty-two implants were placed after 6 month of healing with no significant differences between groups for number of implants, implant size, primary stability and survival. Conclusions rhBMP-2/ACS appears a realistic alternative for augmentation of the edentulous atrophic anterior maxilla. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

One-Year Evaluation of a Simplified Ethanol-Wet Bonding Technique: A Randomized Clinical Trial

O objetivo deste ensaio clínico randomizado foi avaliar o comportamento clínico das restaurações adesivas, usando um adesivo convencional de três passos (CTP), um adesivo autocondicionante de um passo (AUP) e uma técnica simplificada da adesão úmida por etanol (AUET) antes da aplicação de uma resina composta em lesões cervicais não-cariosas. Noventa e três restaurações (31 para cada grupo) foram realizadas em 17 pacientes por um único operador. Nenhum preparo cavitário foi realizado. Depois de 6 e 12 meses, as restaurações foram avaliadas por 2 examinadores previamente treinados, utilizando critérios de Ryge modificados para retenção (kappa=1,00) e adaptação/manchamento marginal (kappa=0,81), e os resultados foram analisados pelos testes Exato de Fisher e Kruskal-Wallis, respectivamente. Não foram observadas diferenças significativas entre os grupos aos 6 e 12 meses para qualquer um dos critérios avaliados (p≥0,05). A análise intra-grupo feita pelos testes Q de Cochran (para retenção) e Wilcoxon (para adaptação/manchamento marginal) revelou diferenças significativas entre os intervalos de tempo baseline/12 meses para a adaptação marginal no AUP (p=0,0180) e manchamento marginal no CTP (p=0,0117). A análise de sobrevivência para o critério retenção realizada utilizando o teste de log-rank não apresentou diferenças significantes (p≥0,05). As restaurações feitas utilizando a técnica simplificada da adesão úmida por etanol comportaram-se igualmente às outras estratégias adesivas empregadas.

Application of continuous positive airway pressure in the delivery room: a multicenter randomized clinical trial

This study evaluated whether the use of continuous positive airway pressure (CPAP) in the delivery room alters the need for mechanical ventilation and surfactant during the first 5 days of life and modifies the incidence of respiratory morbidity and mortality during the hospital stay. The study was a multicenter randomized clinical trial conducted in five public university hospitals in Brazil, from June 2008 to December 2009. Participants were 197 infants with birth weight of 1000-1500 g and without major birth defects. They were treated according to the guidelines of the American Academy of Pediatrics (APP). Infants not intubated or extubated less than 15 min after birth were randomized for two treatments, routine or CPAP, and were followed until hospital discharge. The routine (n=99) and CPAP (n=98) infants studied presented no statistically significant differences regarding birth characteristics, complications during the prenatal period, the need for mechanical ventilation during the first 5 days of life (19.2 vs 23.4%, P=0.50), use of surfactant (18.2 vs 17.3% P=0.92), or respiratory morbidity and mortality until discharge. The CPAP group required a greater number of doses of surfactant (1.5 vs 1.0, P=0.02). When CPAP was applied to the routine group, it was installed within a median time of 30 min. We found that CPAP applied less than 15 min after birth was not able to reduce the need for ventilator support and was associated with a higher number of doses of surfactant when compared to CPAP applied as clinically indicated within a median time of 30 min.

The influence of resistance exercise with emphasis on specific contractions (concentric vs. eccentric) on muscle strength and post-exercise autonomic modulation: a randomized clinical trial

Contextualização:Ações concêntricas apresentam maior estresse cardiovascular quando comparadas às excêntricas. Entretanto, não se sabe a influência desses tipos de ações no comportamento da modulação autonômica cardíaca durante o processo de recuperação pós-esforço.Objetivo:Comparar o efeito de um treinamento resistido para o grupo extensor do joelho realizado com ênfase concêntrica vs excêntrica sobre a força muscular e a recuperação pós-exercício considerando índices de variabilidade de frequência cardíaca (VFC) em jovens saudáveis.Método:Cento e cinco homens, com idades entre 18 e 30 anos, foram randomizados em quatro grupos: controle concêntrico (CCONC), controle excêntrico (CEXC), treinamento concêntrico (TCONC) e treinamento excêntrico (TEXC). Os grupos CCONC e CEXC realizaram uma sessão de exercício reduzido (ER) para o grupo extensor do joelho [três séries de uma repetição a 100% de uma repetição máxima (1RM)], e os grupos TCONC e TEXC realizaram dez sessões de treinamento. A VFC foi analisada no momento basal e na recuperação após as sessões (T1, T2, T3 e T4).Resultados:Observou-se aumento da força muscular para o grupo TEXC. Em relação à modulação autonômica cardíaca, observou-se, em comparação ao momento basal, aumento dos índices SDNN e SD2 no momento T1 nos grupos CCONC e CEXC e aumento dos índices RMSSD, SD1 e AF (ms2) nos momentos T1, T2 e T4 no grupo TEXC.Conclusões:Conclui-se que o treinamento resistido realizado com ênfase em contrações excêntricas promoveu ganho de força e aumento da modulação vagal cardíaca durante o processo de recuperação em relação à condição basal.

Phase I clinical trial of cell therapy in patients with advanced chronic obstructive pulmonary disease: follow-up of up to 3 years

BACKGROUND Chronic obstructive pulmonary disease is a major inflammatory disease of the airways and an enormous therapeutic challenge. Within the spectrum of chronic obstructive pulmonary disease, pulmonary emphysema is characterized by the destruction of the alveolar walls with an increase in the air spaces distal to the terminal bronchioles but without significant pulmonary fibrosis. Therapeutic options are limited and palliative since they are unable to promote morphological and functional regeneration of the alveolar tissue. In this context, new therapeutic approaches, such as cell therapy with adult stem cells, are being evaluated.OBJECTIVE This article aims to describe the follow-up of up to 3 years after the beginning of a phase I clinical trial and discuss the spirometry parameters achieved by patients with advanced pulmonary emphysema treated with bone marrow mononuclear cells.METHODS Four patients with advanced pulmonary emphysema were submitted to autologous infusion of bone marrow mononuclear cells. Follow-ups were performed by spirometry up to 3 years after the procedure.RESULTS The results showed that autologous cell therapy in patients having chronic obstructive pulmonary disease is a safe procedure and free of adverse effects. There was an improvement in laboratory parameters (spirometry) and a slowing down in the process of pathological degeneration. Also, patients reported improvements in the clinical condition and quality of life.CONCLUSIONS Despite being in the initial stage and in spite of the small sample, the results of the clinical protocol of cell therapy in advanced pulmonary emphysema as proposed in this study, open new therapeutic perspectives in chronic obstructive pulmonary disease. It is worth emphasizing that this study corresponds to the first study in the literature that reports a change in the natural history of pulmonary emphysema after the use of cell therapy with a pool of bone marrow mononuclear cells.

Cardiovascular risk and mortality in end-stage renal disease patients undergoing dialysis: sleep study, pulmonary function, respiratory mechanics, upper airway collapsibility, autonomic nervous activity, depression, anxiety, stress and quality of life: a prospective, double blind, randomized controlled clinical trial

Background: Chronic kidney disease (CKD) is one of the most serious public health problems. The increasing prevalence of CKD in developed and developing countries has led to a global epidemic. The hypothesis proposed is that patients undergoing dialysis would experience a marked negative influence on physiological variables of sleep and autonomic nervous system activity, compromising quality of life.Methods/Design: A prospective, consecutive, double blind, randomized controlled clinical trial is proposed to address the effect of dialysis on sleep, pulmonary function, respiratory mechanics, upper airway collapsibility, autonomic nervous activity, depression, anxiety, stress and quality of life in patients with CKD. The measurement protocol will include body weight (kg); height (cm); body mass index calculated as weight/height(2); circumferences (cm) of the neck, waist, and hip; heart and respiratory rates; blood pressures; Mallampati index; tonsil index; heart rate variability; maximum ventilatory pressures; negative expiratory pressure test, and polysomnography (sleep study), as well as the administration of specific questionnaires addressing sleep apnea, excessive daytime sleepiness, depression, anxiety, stress, and quality of life.Discussion: CKD is a major public health problem worldwide, and its incidence has increased in part by the increased life expectancy and increasing number of cases of diabetes mellitus and hypertension. Sleep disorders are common in patients with renal insufficiency. Our hypothesis is that the weather weight gain due to volume overload observed during interdialytic period will influence the degree of collapsibility of the upper airway due to narrowing and predispose to upper airway occlusion during sleep, and to investigate the negative influences of haemodialysis in the physiological variables of sleep, and autonomic nervous system, and respiratory mechanics and thereby compromise the quality of life of patients.

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)

Open-Flap Versus Flapless Esthetic Crown Lengthening: 12-Month Clinical Outcomes of a Randomized Controlled Clinical Trial

Background: Excessive gingival display (EGD) has a negative impact on a pleasant smile. Minimally invasive therapeutic modalities have become the standard treatment in many dentistry fields. Therefore, the aim of this study is to compare the clinical outcomes of open-flap (OF) and minimally invasive flapless (FL) esthetic crown lengthening (ECL) for the treatment of EGD.Methods: A split-mouth randomized controlled trial was conducted in 28 patients presenting with EGD. Contralateral quadrants received ECL using OF or FL techniques. Clinical parameters were evaluated at baseline and 3, 6, and 12 months post-surgery. The local levels of receptor activator of nuclear factor-kappa B ligand (RANKL) and osteoprotegerin (OPG) were assessed by enzyme-linked immunosorbent assay at baseline and 3 months. Patients' perceptions regarding morbidity and esthetic appearance were also evaluated. Periodontal tissue dimensions were obtained by computed tomography at baseline and correlated with the changes in the gingival margin (GM).Results: Patients reported low morbidity and high satisfaction with esthetic appearance for both procedures (P > 0.05). RANKL and OPG concentrations were increased in the OF group at 3 months (P < 0.05). Probing depths were reduced for both groups at all time points, compared with baseline (P < 0.05). There were no differences between groups for GM reduction at any time point (P > 0.05).Conclusions: FL and OF surgeries produced stable and similar clinical results up to 12 months. FL ECL may be a predictable alternative approach for the treatment of EGD.

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).

Clinical Trial Evaluating Color Change and Tooth Sensitivity Throughout and Following In-office Bleaching

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