Equine tendonitis therapy using mesenchymal stem cells and platelet concentrates: A randomized controlled trial

Introduction. Tendon injury is a major cause of lameness and decreased performance in athletic equines. Various therapies for tendonitis have been described; however, none of these therapies results in complete tissue regeneration, and the injury recurrence rate is high even after long recovery periods involving rest and physiotherapy. Methods. A lesion was induced with collagenase gel in the superficial digital flexor tendon in the center portion of the metacarpal region of eight equines of mixed breed. After two weeks, the lesions of the animals in the treated and control groups were treated through the intralesional administration of mesenchymal stem cells derived from adipose tissue (adMSCs) suspended in platelet concentrate (PC) and with phosphate buffered saline (PBS), respectively. Serial ultrasound analyses were performed every two weeks. After 16 weeks of therapy, a biopsy was performed for histopathological, immunohistochemical and gene expression (type I collagen (COL1A1), type III collagen (COL3A1), tenascin-C (TNC), tenomodulin (TNMD), and scleraxis (SCX)) analyses. Results: Differences in the ultrasound and histopathological analyses were observed between the groups. Improved results were reported in the group treated with adMSCs suspended in PC. There was no difference in the gene expression levels observed after the different treatments. The main results observed from the histopathological evaluation of the treated group were as follows: a prevention of the progression of the lesion, a greater organization of collagen fibers, and a decreased inflammatory infiltrate. A lack of progression of the lesion area and its percentage was observed in the ultrasound image, and increased blood flow was measured by Power Doppler. Conclusions: The use of adMSCs combined with PC for the therapy of experimentally induced tendonitis prevented the progression of the tendon lesion, as observed in the ultrasound examination, and resulted in a greater organization and decreased inflammation, as observed in the histopathological evaluation. These data demonstrate the therapeutic potential of this therapy for the treatment of equine tendonitis. © 2013 Carvalho et al.; licensee BioMed Central Ltd.

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.

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.

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).

Hemostatic profile and thromboembolic risk in healthy dogs treated with prednisone: a randomized controlled trial

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

Patient Education and Self-Care for the Management of Jaw Pain upon Awakening: A Randomized Controlled Clinical Trial Comparing the Effectiveness of Adding Pharmacologic Treatment with Cyclobenzaprine or Tizanidine

Aims: To compare the effectiveness of adding cyclobenzaprine, tizanidine, or placebo to patient education and a self-care management program for patients with myofascial pain and specifically presenting with jaw pain upon awakening. Methods: Forty-five patients with a diagnosis of myofascial pain based on the guidelines of the American Academy of Orofacial Pain participated in this 3-week study. The subjects were randomly assigned into one of three groups: placebo group, TZA group (tizanidine 4 mg), or CYC group (cyclobenzaprine 10 mg). Patients were evaluated for changes in pain intensity, frequency, and duration by using the modified Severity Symptoms Index and changes in sleep quality with the use of the Pittsburgh Sleep Quality Index. Data were analyzed by ANOVA and post-hoc or nonparametric statistical tests as appropriate. Results: All three groups had a reduction in pain symptoms and improvement of sleep quality based on a comparison of pretreatment and treatment scores. However, no significant differences among the groups were observed at the posttreatment evaluation. Conclusion: The use of tizanidine or cyclobenzaprine in addition to self-care management and patient education was not more effective than placebo for the management of patients with myofascial jaw pain upon awakening.

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.