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1.
Oper Dent ; 45(1): E1-E10, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31891544

RESUMO

OBJECTIVES: This study aimed to evaluate the desensitizing effect of a prefilled disposable tray containing potassium nitrate and fluoride on the self-reported tooth sensitivity (TS) and the bleaching efficacy of 40% hydrogen peroxide bleaching agent used for in-office bleaching in comparison with potassium nitrate and fluoride gel applied in a conventional-delivered tray system in an equivalence clinical trial. METHODS AND MATERIALS: Seventy-eight patients, with a right maxillary canine darker than A3, were selected for this single-blind (evaluators), randomized clinical trial. Teeth were bleached in two sessions with a one-week interval in between. Before in-office bleaching, the prefilled disposable tray or conventional tray containing potassium nitrate and fluoride was used for 15 minutes. Subsequently, the bleaching agent was applied in two 20-minute applications (per the manufacturer's directions) in each session. The color change was evaluated by subjective (Vita Classical and Vita Bleachedguide) and objective (Easyshade Advance Spectrophotometer) methods at baseline and 30 days after the first bleaching session. TS was recorded for up to 48 hours using a 0-10 visual analog scale. The absolute risk was evaluated by chi-square test, while the intensity of TS was evaluated by McNemar test (α=0.05). Color change in shade guide units and ΔE was analyzed by Student t-test for independent samples (α=0.05). RESULTS: Significant whitening was observed in both groups after 30 days of clinical evaluation. The use of different methods of desensitizer in a tray did not influence the absolute risk and intensity of TS (p>0.05), although a tendency of lower risk of TS with the prefilled disposable tray containing potassium nitrate and fluoride was observed. CONCLUSION: The use of a prefilled disposable tray containing potassium nitrate and fluoride before the application of the in-office bleaching product did not affect the whitening degree and decreased self-reported TS when compared with a conventional-delivered tray system.


Assuntos
Sensibilidade da Dentina , Clareadores Dentários , Clareamento Dental , Descoloração de Dente , Humanos , Peróxido de Hidrogênio , Método Simples-Cego , Resultado do Tratamento
3.
J Urol ; 203(1): 211, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31464565
4.
JAMA ; 322(23): 2303-2312, 2019 12 17.
Artigo em Inglês | MEDLINE | ID: mdl-31846014

RESUMO

Importance: Rocuronium and succinylcholine are often used for rapid sequence intubation, although the comparative efficacy of these paralytic agents for achieving successful intubation in an emergency setting has not been evaluated in clinical trials. Succinylcholine use has been associated with several adverse events not reported with rocuronium. Objective: To assess the noninferiority of rocuronium vs succinylcholine for tracheal intubation in out-of-hospital emergency situations. Design, Setting and Participants: Multicenter, single-blind, noninferiority randomized clinical trial comparing rocuronium (1.2 mg/kg) with succinylcholine (1 mg/kg) for rapid sequence intubation in 1248 adult patients needing out-of-hospital tracheal intubation. Enrollment occurred from January 2014 to August 2016 in 17 French out-of-hospital emergency medical units. The date of final follow-up was August 31, 2016. Interventions: Patients were randomly assigned to undergo tracheal intubation facilitated by rocuronium (n = 624) or succinylcholine (n = 624). Main Outcomes and Measures: The primary outcome was the intubation success rate on first attempt. A noninferiority margin of 7% was chosen. A per-protocol analysis was prespecified as the primary analysis. Results: Among 1248 patients who were randomized (mean age, 56 years; 501 [40.1%] women), 1230 (98.6%) completed the trial and 1226 (98.2%) were included in the per-protocol analysis. The number of patients with successful first-attempt intubation was 455 of 610 (74.6%) in the rocuronium group vs 489 of 616 (79.4%) in the succinylcholine group, with a between-group difference of -4.8% (1-sided 97.5% CI, -9% to ∞), which did not meet criteria for noninferiority. The most common intubation-related adverse events were hypoxemia (55 of 610 patients [9.0%]) and hypotension (39 of 610 patients [6.4%]) in the rocuronium group and hypoxemia (61 of 616 [9.9%]) and hypotension (62 of 616 patients [10.1%]) in the succinylcholine group. Conclusions and Relevance: Among patients undergoing endotracheal intubation in an out-of-hospital emergency setting, rocuronium, compared with succinylcholine, failed to demonstrate noninferiority with regard to first-attempt intubation success rate. Trial Registration: ClinicalTrials.gov Identifier: NCT02000674.


Assuntos
Serviços Médicos de Emergência , Rocurônio/administração & dosagem , Succinilcolina/administração & dosagem , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Método Simples-Cego
5.
Medicine (Baltimore) ; 98(51): e18188, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31860965

RESUMO

AIM: We compared the effects of 50% N2O and N2O titration in burn management to alleviate pain and anxiety associated with burn dressing. METHODS: In this single-blind prospective randomized controlled trial, 70 stable adult burn patients were randomized to 2 groups during May 2015 to January 2016. The experimental group was titrated with N2O ranging from 30% to the ideal sedation concentration before dressing change until the end. The control group was treated with 50% N2O 2 minutes before dressing change until the end. Pain, anxiety, vital signs, and the highest concentrations of N2O inhaled were recorded at 1 minute before N2O inhalation (T0), dismantling of outer (T1), inner dressings (T2), debridement (T3), drug-smearing (T4), bandaging (T5), and 10 minutes after completion of the procedure (T6). RESULTS: The pain and anxiety scores in the experimental group performed significantly less than the control group during T2-T6. The systolic blood pressure in T2 and the heart rate at T2 and T3 varied significantly between the 2 groups. The highest N2O concentrations of the experimental group were mainly 60% to 70% at T2 (87.9%), T3 (87.9%), and T4 (81.8%). CONCLUSION: N2O titration significantly reduced pain and anxiety in burn patients, with minimal side effects.


Assuntos
Analgésicos não Entorpecentes/uso terapêutico , Ansiolíticos/uso terapêutico , Queimaduras/terapia , Óxido Nitroso/uso terapêutico , Administração por Inalação , Adolescente , Adulto , Idoso , Analgésicos não Entorpecentes/administração & dosagem , Ansiolíticos/administração & dosagem , Ansiedade/prevenção & controle , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Óxido Nitroso/administração & dosagem , Manejo da Dor , Método Simples-Cego , Adulto Jovem
6.
Eur J Paediatr Dent ; 20(4): 325-329, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31850778

RESUMO

AIM: Plaque removal from first permanent molar teeth was evaluated when conventional and a new silicone tooth and gum brush was used. Also, the effectiveness of parents' brushing was compared with childrens'. MATERIALS AND METHODS: Study design: This crossover clinical study was conducted with 9 children aged 5 to 7 years, with 18 mandibular first permanent molar teeth which were partially erupted. Four appointments were planned at one-week intervals and at every appointment, dental plaque on teeth was disclosed first. At their first appointment, the children were given a conventional toothbrush, and at their second appointment they were given a silicone tooth andgum brush . Then, at the third appointment, parents performed brushing with a conventional toothbrush, and then brushed with a silicone tooth & gum brush at the fourth appointment. Before and after brushing, photographs were taken for baseline and final plaque scores to determine Occlusal Plaque Index with Image Analysis Software Program. STATISTICS: Anova was used for comparison of groups with p<0.05 considered to be significant. RESULTS: There was statistically significant difference between baseline and final plaque scores among all of the groups (p<0.05) but, there was not statistically significant difference between the groups (p>0.05). CONCLUSIONS: Children under the age of nine are usually believed to lack the developmental skills needed to brush their own teeth, and as a result, the silicone tooth & gum brush might be recommended instead of brushing with parents.


Assuntos
Placa Dentária , Escovação Dentária , Criança , Pré-Escolar , Estudos Cross-Over , Índice de Placa Dentária , Desenho de Equipamento , Humanos , Pais , Método Simples-Cego
7.
Int. arch. otorhinolaryngol. (Impr.) ; 23(4): 433-439, Out.-Dez. 2019. ilus
Artigo em Inglês | LILACS | ID: biblio-1024413

RESUMO

Introduction: Studies have reported that although speech perception in noise was unaltered with and without digital noise reduction (DNR), the annoyance toward noise measured by acceptable noise level (ANL) was significantly improved by DNR with the range between 2.5 and 4.5 dB. It is unclear whether a similar improvement would be observed in those individuals who have an ANL ≥ 14 dB (predictive of poor hearing aid user) often rejects their aid because of annoyance toward noise. Objectives: (a) To determine the effect of activation of DNR on the improvement in the aided ANL from low- and high-ANL groups; and (b) to predict the change in ANL when DNR was activated. Method: Ten bilateral mild to severe sloping sensorineural hearing loss (SNHL) participants in each of the low- and high-ANL groups were involved. These participants were bilaterally fitted with receiver in canal (RIC) hearing aids (Oticon, Smorum, Egedal, Denmark) with a DNR processor. Both SNR-50% (Signal to noise ratio (in dB) required to achieve 50 % speech recognition) and ANL were assessed in DNR-on and DNR-off listening conditions. Results: Digital noise reduction has no effect on SNR-50 in each group. The annoyance level was significantly reduced in the DNR-on than DNR-off condition in the low-ANL group. In the high-ANL group, a strong negative correlation was observed between the ANL in DNR off and a change in ANL after DNR was employed in the hearing aid (benefit). The benefit of DNR on annoyance can be effectively predicted by baseline-aided ANL by linear regression. Conclusion: Digital noise reduction reduced the annoyance level in the high-ANL group, and the amount of improvement was related to the baseline-aided ANL value (AU)


Assuntos
Pessoa de Meia-Idade , Idoso , Limiar Auditivo/fisiologia , Percepção da Fala/fisiologia , Efeitos do Ruído , Auxiliares de Audição , Método Simples-Cego , Perda Auditiva Neurossensorial/fisiopatologia
8.
Medicine (Baltimore) ; 98(45): e17946, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31702684

RESUMO

BACKGROUND: Adaptive balance control is often compromised in children with developmental coordination disorder (DCD). Neuromuscular training (NMT) is commonly used in clinical settings to improve neuromuscular control and hence balance performance in these children. However, its effectiveness has not been proven scientifically. This randomized controlled study aimed to explore the effectiveness of NMT for improving adaptive balance performance and the associated leg muscle activation times in children with DCD. METHODS: Eighty-eight children with DCD were randomly assigned to the NMT or control group (44 per group). The NMT group received two 40-minute NMT sessions/week for 3 months, whereas the control group received no intervention. The outcomes were measured at baseline and 3 and 6 months. The primary outcome was the sway energy score (SES) in both the toes-up and toes-down conditions as derived using the Adaptation Test (ADT). Secondary outcomes included the medial gastrocnemius, medial hamstring, tibialis anterior and rectus femoris muscle activation onset latencies during ADT, measured using surface electromyography and accelerometry. Data were analyzed using a repeated measures analysis of covariance based on the intention-to-treat principle. RESULTS: At 3 months, no significant within-group or between-group differences were noted in the SESs for either group. At 6 months, the toes-down SES decreased by 6.8% compared to the baseline value in exclusively the NMT group (P = .004). No significant time, group or group-by-time interaction effects were observed in any leg muscle activation outcomes. CONCLUSIONS: Short-term NMT failed to improve adaptive balance performance and leg muscle activation times in children with DCD. Further studies should explore the clinical applications of longer-term task-specific interventions intended to improve the adaptive balance performance of these children.


Assuntos
Terapia por Exercício/métodos , Transtornos das Habilidades Motoras/reabilitação , Equilíbrio Postural , Adaptação Fisiológica , Criança , Eletromiografia , Feminino , Humanos , Masculino , Método Simples-Cego , Resultado do Tratamento
9.
Medicine (Baltimore) ; 98(44): e17717, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31689808

RESUMO

BACKGROUND: Cancer-related fatigue (CRF) is a major symptom experienced by lung cancer patients receiving chemotherapy and radiation therapy. Since CRF has a multidimensional influence on cancer patients, they may experience physical weakening, a decline in cognitive function, and depression from emotional consequences. Kyung-Ok-Ko is used for improving fatigue or weak physical constitution. It is known to be effective in immune activation, reducing fatigue, and enhancing cognitive function. Although Kyung-Ok-Ko is clinically used for the treatment of CRF, its efficacy and safety against CRF in lung cancer patients are yet to be studied. Therefore, we aimed to investigate the efficacy and safety of Kyung-Ok-Ko. METHODS: This is a randomized, placebo-controlled, patients-assessor blind, parallel-group, single-center clinical trial. Lung cancer patients with CRF, after termination of chemo or radiation therapies, are randomized in a 1:1 ratio to receive either Kyung-Ok-Ko or placebo for 6 weeks. The primary outcome is Brief Fatigue Inventory (BFI). The secondary outcomes include Visual Analog Fatigue Scale (VAFS), Functional Assessment of Cancer Therapy (FACIT) Fatigue scale, Hospital Anxiety Depression Scale (HADS), Montreal Cognitive Assessment Korean version (MoCA-K), and Korean pattern identification questionnaire. Adverse events are evaluated by Common Terminology Criteria for Adverse Events (CTCAE). All outcomes and adverse events are assessed at the baseline, mid-treatment, post-treatment, and at 1-month follow-up. DISCUSSION: This study investigates whether Kyung-Ok-Ko can alleviate CRF in lung cancer patients. The results of this study will provide clinical evidence for the application of Kyung-Ok-Ko in the treatment of CRF in lung cancer patients. TRIAL REGISTRATION: Korean Clinical Trial Registry (http://cris.nih.go.kr; registration number: KCT000666).Trial status: Currently, participant recruitment is ongoing.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Fadiga/tratamento farmacológico , Neoplasias Pulmonares/complicações , Adulto , Fadiga/etiologia , Feminino , Humanos , Masculino , Ensaios Clínicos Controlados Aleatórios como Assunto , Método Simples-Cego , Resultado do Tratamento , Adulto Jovem
10.
Medicine (Baltimore) ; 98(44): e17738, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31689821

RESUMO

This study aimed to evaluate a novel real-time rotational optical coherence tomography (OCT) imaging system (OCTIS) with a fiber-optic probe to look at endometrium and to correlate the OCTIS images with standard histology. OCT could obtain real-time images resembling histological examination. With recent development of customized probes, it allows OCT to be used in the field of gynecology.This is a pilot, prospective, ex-vivo and observational study. Women underwent hysterectomy for various gynecological conditions were recruited and OCTIS images were obtained from endometrium of 15 fresh uterus specimens immediately after hysterectomy. The excised uterus was cut open and OCTIS imaging was obtained. The scanned region of endometrium was excised for histological examination and OCTIS images were precisely compared to corresponding histological images and ultrasound images. Blinded qualitative analysis on OCTIS images was performed by 2 assessors to determine inter-rating reliability on the histopathological diagnosis.Epithelium, glands, cysts, and stroma of endometrium were clearly seen by the OCTIS. Different phases of menstrual cycle of normal endometrium could be differentiated and pathological condition such as hyperplastic and dysplasic endometrium, which corresponded well with histological findings, could be identified. The inter-rater reliability between assessors on overall OCTIS endometrium and neoplastic OCTIS endometrium was moderate (Kendall τb of 0.58) and substantial (Kendall τb of 0.76), respectively.OCTIS can provide real-time, high-resolution and rotational imaging modality to view endometrial structure with high consistency with histological examination and satisfactory agreement between observers. It has a great potential to be developed in the clinical use of endometrial assessment for gynecological applications.


Assuntos
Hiperplasia Endometrial/diagnóstico por imagem , Endométrio/diagnóstico por imagem , Aumento da Imagem/métodos , Tomografia de Coerência Óptica/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Endométrio/patologia , Feminino , Humanos , Histerectomia , Aumento da Imagem/instrumentação , Pessoa de Meia-Idade , Variações Dependentes do Observador , Projetos Piloto , Período Pós-Operatório , Estudos Prospectivos , Reprodutibilidade dos Testes , Método Simples-Cego , Tomografia de Coerência Óptica/instrumentação
11.
Medicine (Baltimore) ; 98(44): e17809, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31689865

RESUMO

INTRODUCTION: Almost all patients with end-of-life cancer experience cancer-related fatigue; however, there are only a few known effective coping methods. OBJECTIVES: We will conduct a prospective, multi-center, single-blinded randomized controlled study to evaluate the efficacy of acupuncture for cancer-related fatigue in patients with end-of-life cancer. METHODS: We will enroll 120 patients with cancer hospitalized in a palliative care unit or receiving consultation from a palliative care team in four hospitals. We will add acupuncture treatment; specifically, contact needle therapy (CNT), consisting of an intervention per week period to the usual care. The primary outcome measure will be the Cancer Fatigue Scale (CFS) score while the secondary outcome measures will be the Numerical Rating Scale (NRS) score for fatigue, pain, and salivary amylase levels. CONCLUSION: We will evaluate the possibility of using acupuncture therapy, that is, CNT, in relieving fatigue sensation in patients with advanced cancer. TRIAL REGISTRATION: UMIN000028304, registered on July 21st, 2017; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032401.


Assuntos
Terapia por Acupuntura/métodos , Fadiga/terapia , Neoplasias/complicações , Neoplasias/terapia , Cuidados Paliativos , Adulto , Fadiga/etiologia , Humanos , Medicina Kampo , Estudos Prospectivos , Método Simples-Cego , Assistência Terminal
12.
Medicine (Baltimore) ; 98(44): e17839, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31689874

RESUMO

INTRODUCTION: The incidence of malignant melanoma has been rising steadily over the past decades and Merkel cell carcinoma is a highly aggressive neuroendocrine skin tumor with a high mortality rate. Sentinel lymph node (SLN) biopsy is a recommended prognostic tool in primary cutaneous malignant melanomas of intermediate thickness and in all clinically node-negative Merkel cell carcinomas. The gold standard method for identification of SLNs is lymphoscintigraphy, which involves radioactive tracers. Indocyanine green-based near-infrared fluorescence imaging (NIRFI) has been also used for intraoperative SLN identification. We aim to evaluate the diagnostic sensitivity of the VisionSense VS3 NIRFI device for SNL identification. This device uses stereoscopic 3D high definition for both fluorescence and visible light imaging. Our hypothesis is that SLNs may be identified transcutaneously using fluorescent dye injections and NIRFI; therefore, obviating the need for lymphoscintigraphy in the future. METHODS AND ANALYSIS:: lymph node identification in skin malignancy using indocyanine green transcutaneously is a prospective diagnostic sensitivity study conducted at the Department of Plastic and Hand Surgery at the University Hospital Berne, Inselspital, Switzerland. The study aims at recruiting 93 patients (start date September 2017) to compare the accuracy of VisionSense VS3 camera at identifying SLNs transcutaneously with the current gold standard, lymphoscintigraphy. Moreover, a secondary objective is to determine if anatomical location of the SLN and patient factors (eg, body mass index, age) have an impact on the ability of VisionSense to detect SLNs when compared with the same gold standard. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT03545334.


Assuntos
Corantes Fluorescentes , Verde de Indocianina , Imagem Óptica/instrumentação , Imagem Óptica/métodos , Linfonodo Sentinela/diagnóstico por imagem , Neoplasias Cutâneas/diagnóstico por imagem , Administração Cutânea , Adulto , Carcinoma de Célula de Merkel/diagnóstico por imagem , Carcinoma de Célula de Merkel/patologia , Humanos , Melanoma/diagnóstico por imagem , Melanoma/patologia , Estudos Prospectivos , Método Simples-Cego , Neoplasias Cutâneas/patologia
13.
Rev Assoc Med Bras (1992) ; 65(9): 1161-1167, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31618331

RESUMO

OBJECTIVE: To investigate the use of Bilevel Positive Airway Pressure (BiPAP) in morbidly obese individuals in two moments following bariatric surgery (Roux-en-Y gastric bypass): post-anesthetic recovery (PAR) and first postoperative day (1PO). DESIGN: Randomized and blinded clinical trial. METHODS: We studied 40 morbidly obese individuals aged between 25 and 55 years who underwent pulmonary function test and chest X-ray preoperatively, and on the day of discharge (2nd day after surgery). They were randomly allocated into two groups: PAR-G (BiPAP in PAR for one hour), and 1PO-G (BIPAP for one hour on the 1PO). RESULTS: In the PAR-G and 1PO-G, respectively there were significant reductions in slow vital capacity (SVC) (p=0.0007 vs. p<0.0001), inspiratory reserve volume (IRV) (p=0.0016 vs. p=0.0026), and forced vital capacity (FVC) (p=0.0013 vs. p<0.0001) and expiratory reserve volume (ERV) was maintained only for the PAR-G (p=0.4446 vs. p=0.0191). Comparing the groups, the SVC (p=0.0027) and FVC (p=0.0028) showed a significant difference between the treatments, while the PAR-G showed smaller declines in these capacities. The prevalence of atelectasis was 10% for the PAR-G and 30% for the 1PO-G (p=0.0027). CONCLUSION: Thus, the use of BiPAP in PAR can promote restoration of ERV and contribute to the reduction of atelectasis.


Assuntos
Cirurgia Bariátrica/reabilitação , Pressão Positiva Contínua nas Vias Aéreas , Atelectasia Pulmonar/epidemiologia , Adulto , Volume de Reserva Expiratória , Feminino , Humanos , Pulmão/fisiopatologia , Pessoa de Meia-Idade , Obesidade Mórbida/cirurgia , Período Pós-Operatório , Prevalência , Atelectasia Pulmonar/prevenção & controle , Método Simples-Cego , Espirometria , Capacidade Vital
14.
Medicine (Baltimore) ; 98(38): e17254, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31567997

RESUMO

BACKGROUND: Bleeding modifies the surgeon's view of the field during transsphenoidal endoscopic pituitary surgery. Since ventilation can alter venous return, we compared the effect of volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) on intraoperative bleeding. METHODS: Eighty-six patients were randomized to VCV or PCV in this single blinded study; comparisons concerned 42 in the PCV group and 43 in the VCV group. RESULTS: Intraoperative bleeding, the primary endpoint, did not differ between groups whether analysis focused on 7 levels of the score, from minimal bleeding to bleeding with significant change in the conduct of surgical procedure (P = .89) or on a stratification into 3 categories, mild, moderate, and major (P = .47). Median [interquartile range] peak airway pressure was lower in the PCV group (13.5 [12.5-15] vs 16.3 [14.4-19.1] cm H2O, P < .001) while mean airway pressures were similar (P = .08). Means ±â€ŠSD of tidal volumes were lower in the VCV group when expressed as absolute values (470.6 ±â€Š84 vs 434.7 ±â€Š71.7 ml, P = .05) or as tidal volume/theoretical ideal weight ratio (6.7 [6.5-7] vs 7.2 [6.9-7.9], P < .001). The 2 groups were similar for postoperative complications and number of patients cured. CONCLUSION: In conclusion, ventilation mode does not influence intraoperative bleeding during transsphenoidal pituitary surgery. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01891838; July 3, 2013.


Assuntos
Hipófise/cirurgia , Respiração Artificial , Adulto , Idoso , Perda Sanguínea Cirúrgica , Endoscopia/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Respiração com Pressão Positiva , Respiração Artificial/efeitos adversos , Respiração Artificial/métodos , Método Simples-Cego , Seio Esfenoidal , Adulto Jovem
15.
Medicine (Baltimore) ; 98(39): e16976, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31574796

RESUMO

RATIONALE: Halitosis is an unpleasant odor that emanates from the mouth. Studies show halitosis returns in a week, after treatment with PDT. Probably, bacteria living in the periodontal sulcus could recolonize the dorsum of the tongue. Until nowadays, there are no study in adult population that associates halitosis and periodontal treatment with follow-up evaluation. The aim of this randomized, controlled, single-blinded clinical trial is to treat oral halitosis in healthy adults with photodynamic therapy (PDT), associated with periodontal treatment and follow them up for 3 months. PATIENT CONCERNS:: the concerns assessments will be done over the study using anamnesis interviews and specific questionnaire. DIAGNOSES:: halitosis will be evaluated by OralChroma. INTERVENTIONS: The participants (n = 40) with halitosis will be randomized into 2 groups: G1-treatment with PDT (n = 20) or G2-cleaning of the tongue with a tongue scraper (n = 20). OUTCOMES: Halitosis will be evaluated by measuring volatile sulfur compounds using gas chromatography. After the treatments, a second evaluation will be performed, along with a microbiological analysis (RT-PCR) for the identification of the bacteria T. denticola. The assessment of halitosis and the microbiological analysis will be repeated. After that, patients will receive periodontal treatment. The participants will return after 1 week and 3 months for an additional evaluation. Quality of life will be measured by Oral Health Impact Profile questionnaire (OHIP-14). LESSONS: This protocol will determine the effectiveness of phototherapy regarding the reduction of halitosis in adults. clinicaltrials.gov NCT03996915. ETHICS AND DISSEMINATION: This protocol received approval from the Human Research Ethics Committee of Universidade Nove de Julho (certificate number: 3.257.104). The data will be published in a peer-reviewed periodical.


Assuntos
Halitose/tratamento farmacológico , Doenças Periodontais/terapia , Fotoquimioterapia , Cromatografia Gasosa , Seguimentos , Halitose/etiologia , Halitose/microbiologia , Humanos , Pessoa de Meia-Idade , Higiene Bucal , Doenças Periodontais/complicações , Doenças Periodontais/microbiologia , Fármacos Fotossensibilizantes/uso terapêutico , Recidiva , Método Simples-Cego , Resultado do Tratamento , Treponema denticola/isolamento & purificação
16.
Medicine (Baltimore) ; 98(39): e17354, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31574878

RESUMO

INTRODUCTION: The incidence, mortality, and treatment costs of sepsis are high and, thus, present a major challenge for critical care medicine. Our previous studies suggest that intestinal metabolite granisetron has a potential therapeutic effect on sepsis. Granisetron is a clinically widely used antiemetic, which is safe, inexpensive, and reliable. However, its value in the treatment of sepsis remains unclear. This study aims to explore the efficacy and safety of granisetron in the treatment of sepsis. METHODS AND ANALYSIS: A single-center, single-blind, randomized, controlled clinical trial will be conducted on 154 patients with sepsis. Patients who meet sepsis 3.0 diagnostic criteria, aged ≥18 and ≤80 years, with PCT ≥ 2 ng/mL will be recruited. Patients will be randomized to receive intravenous granisetron 3 mg every 8 hours (n = 77) or an equal volume of normal saline (n = 77) for a treatment period of 4 days or to ICU discharge. The primary outcome is 28-day all-cause mortality. Secondary outcome measures include requirements for organ function support, changes of organ function, changes in infection biomarkers, changes in inflammatory and immune biomarkers, and the proportion of new organ failure. Adverse events and serious adverse events also will be observed closely. ETHICS AND DISSEMINATION: The study was approved by the Clinical Ethics Committee of Zhujiang Hospital of Southern Medical University (2018-ZZJHZX-009). The trial results will be disseminated at national and international conferences and through peer-reviewed journal. TRIAL REGISTRATION: NCT03924518.URL: www.clinicaltrials.gov. PROTOCOL DATE: 1 May 2019. version 2.1.


Assuntos
Granisetron/administração & dosagem , Sepse/tratamento farmacológico , Antagonistas da Serotonina/administração & dosagem , Choque Séptico/tratamento farmacológico , Administração Intravenosa , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/análise , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Sepse/mortalidade , Choque Séptico/mortalidade , Método Simples-Cego , Resultado do Tratamento , Adulto Jovem
17.
Medicine (Baltimore) ; 98(39): e17355, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31574879

RESUMO

BACKGROUND: Molar incisor hypomineralization (MIH) is a change in the formation of dental enamel of systemic origin that affects at least one of the first 4 permanent molars and usually affects incisors. During the eruption, the affected surfaces tend to fracture, exposing the dentin, which causes excessive sensitivity in addition to making the region very susceptible to the appearance of carious lesions. The objective of this research will be to evaluate the clinical effect of antimicrobial photodynamic therapy (aPDT) in permanent teeth with severe and sensitive MIH. METHODS: The methodology will be based on the selection of patients from 6 to 12 years of age with permanent molar teeth, randomly divided in 2 groups. The selected teeth should have MIH on the occlusal surface, indicated for clinical restorative treatment. In Group 1, aPDT will be applied for the treatment of infected dentin. Afterward, the teeth will be restored with high viscosity glass ionomer cement. In Group 2, the removal of the softened dentin around the side walls of the cavity with sharp dentine curettes and posterior restoration with high viscosity glass ionomer cement will be performed. All patients will have clinical and radiographic follow-up with a time interval of 6 and 12 months. The data obtained will be submitted to descriptive statistical analysis to evaluate the association of categorical variables. Chi-square test and Fisher exact test will be applied, to analyze the correlation between the continuous variables, Pearson correlation test will be applied. For the analysis of dentin density in the scanned radiographic images and the microbiological results for colony-forming units, ANOVA and Kruskal-Wallis will be applied. DISCUSSION: Often in the presence of severe MIH, the presence of dentin sensitivity is also associated with caries lesion, making it even more necessary to respect the principles of minimal intervention. TRIAL REGISTRATION: NCT03904641.


Assuntos
Anti-Infecciosos/uso terapêutico , Hipoplasia do Esmalte Dentário/tratamento farmacológico , Fotoquimioterapia/métodos , Criança , Hipoplasia do Esmalte Dentário/microbiologia , Dentina , Feminino , Humanos , Masculino , Ensaios Clínicos Controlados Aleatórios como Assunto , Método Simples-Cego , Resultado do Tratamento
18.
Medicine (Baltimore) ; 98(43): e17399, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31651843

RESUMO

INTRODUCTION: Schizophrenia is one of the most severe mental disorders with a prevalence of about 1% and a leading cause of disability among young adults. Pharmacotherapy is the mainstay in the management of schizophrenia. However, even with the best of medication, several problems like refractoriness, negative symptoms, frequent relapses, and cognitive impairments persist. METHODS: This is a randomized-controlled clinical study including patients from an urban tertiary hospital and a semi-urban community center, with a between-group, repeated-measures, longitudinal design. This study will recruit 160 patients with DSM 5 diagnosis of schizophrenia who are on stable medication for a minimum of 6 weeks; they will be randomly assigned into 2 arms viz., yoga therapy (YT), and treatment-as-usual (TAU) with 80 patients in each arm. Participants will undergo Clinical, Laboratory, and Radiological assessments at baseline and at intervals of 1 month, 3 months, and 6 months from the baseline. It is hypothesized that yoga will improve psychopathology and emotion processing, increase serum brain derived neurotrophic factor (BDNF) and plasma oxytocin levels and effect changes in cerebral activation in areas of the brain associated with schizophrenia. DISCUSSION: This study aims to measure the efficacy of a Yoga-based intervention as an adjunct in patients with schizophrenia as well as the mechanisms of these effects. TRIAL REGISTRATION: Registered retrospectively with Clinical Trial Registry - India (CTRI) with registration number CTRI/2017/08/009219.


Assuntos
Plasticidade Neuronal , Esquizofrenia/fisiopatologia , Esquizofrenia/terapia , Psicologia do Esquizofrênico , Ioga/psicologia , Adolescente , Adulto , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Método Simples-Cego , Resultado do Tratamento , População Urbana , Adulto Jovem
20.
Pediatr Dent ; 41(5): 354-357, 2019 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-31648665

RESUMO

Purpose: From a physiological standpoint, increasing the pH of anesthetic solution decreases the injection pain and onset time while increasing the depth of anesthesia. The purpose of this study was to compare injection pain and anesthesia onset time of alkalinized and non-alkalinized local anesthetic solutions in pediatric patients. Methods: A prospective, randomized, single-blind, split-mouth design was utilized. The control agent was nonalkalinized two percent lidocaine 1:100,000 (100k) with epinephrine, and the test agent was two percent lidocaine 1:100k with epinephrine alkalinized. The anesthetic agent (test versus control) was selected randomly. Injection pain was measured using the image result for the Wong-Baker Faces Pain Rating Scale and the Ohio State University Behavior Rating Scale. Time of onset was measured using endodontic ice and a timer after two minutes. Results: Sixty-five seven- to 11-year-olds participated in this study. There were no significant differences between the test and control groups for either onset time or injection pain observed by the clinician or reported by the patient for unbuffered versus buffered lidocaine anesthetic solutions. Conclusions: Administration of buffered anesthetics resulted in no observed differences in pain or anesthesia onset time as compared to unbuffered anesthetics. (Pediatr Dent 2019;41(5):354-7).


Assuntos
Anestesia Dentária , Lidocaína , Anestésicos Locais , Criança , Assistência Odontológica , Método Duplo-Cego , Epinefrina , Humanos , Concentração de Íons de Hidrogênio , Ohio , Dor , Medição da Dor , Estudos Prospectivos , Método Simples-Cego , Bicarbonato de Sódio
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