scholarly journals Hygiene protocols for the treatment of denture-related stomatitis: local and systemic parameters analysis - a randomized, double-blind trial protocol

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Adriana B. Ribeiro ◽  
Camila B. de Araújo ◽  
Luiz Eduardo V. Silva ◽  
Rubens Fazan-Junior ◽  
Helio C. Salgado ◽  
...  

Abstract Background Denture-related stomatitis (DS) is chronic multifactorial inflammation, strongly related to the presence of the biofilm that is the complex structure formed by microorganisms held together by a mucus-like matrix of carbohydrate that adheres to different surfaces, including the denture surface. DS has recently been correlated with deleterious cardiovascular alterations. The potential effect of hygiene protocols in the control of DS and randomized clinical trials that address this oral condition with cardiovascular complications are important in clinical decision-making. Material/design A clinical trial, randomized, double-blind, and with parallel groups, will be conducted in Brazil The sample will consist of 100 patients without teeth in both arches, users of at least maxillary complete dentures, and diagnosed with DS, who will be allocated to groups (n = 25 per group) according to the different hygiene protocols: (1) brushing of the palate and immersion of the prosthesis in 0.25% sodium hypochlorite solution (positive control); (2) brushing of the palate and immersion of the prosthesis in 0.15% triclosan solution; (3) brushing of the palate and immersion of the prosthesis in lactose monohydrate; or (4) brushing the palate with citric acid and immersing the prosthesis in lactose monohydrate. The response variables will be heart rate variability and alteration of blood pressure (systemic level), remission of DS, removal of biofilm, reduction of microbial load (colony-forming units (CFU)), mouth and prosthesis odor level, expression of MUC1, proinflammatory cytokines, C-reactive protein (CRP), viscosity, pH and salivary flow (locally); patient-centred qualitative analysis will also be undertaken. Measurements will be performed at baseline and 10 days after the interventions. The results obtained will be statistically analyzed as pertinent, with a level of significance of 0.05. Discussion This study will provide a guideline for clinical practice regarding the use of hygiene protocols in the treatment of oral diseases (DS) mediated by biofilm. Also, it may provide evidence of correlation of oral manifestation with cardiac risk. Trial registration Brazilian Registry of Clinical Trials, RBR-4hhwjb. Registered on 9 November 2018.

2019 ◽  
Author(s):  
Adriana Barbosa Ribeiro(Former Corresponding Author) ◽  
Camila Borba de Araújo ◽  
Luiz Eduardo Silva ◽  
Rubens Fazan-Junior ◽  
Helio Cesar Salgado ◽  
...  

Abstract Background. The Denture-related stomatitis (DS) is a chronic multifactorial inflammation, strongly related to the presence of the biofilm that is the complex structure formed by microorganism held together by a mucus-like a matrix of carbohydrate that adheres to different surfaces, including denture surface. DS has recently been correlated with deleterious cardiovascular alterations. The potential effect of hygiene protocols in the control of DS and Randomized clinical trials that address this oral condition with cardiovascular complications are necessary for clinical decision-making. Material/design. A clinical trial, randomized, double-blind, of parallel groups, will be conducted in Brazil and the sample will be composed of 100 patients without teeth in both arches, users of at least maxillary complete dentures, diagnosed with DS that will be allocated in groups (n=25), according to the different hygiene protocols: (1) brushing of the palate and immersion of the prosthesis in 0.25% sodium hypochlorite solution (positive control); (2) brushing of the palate and immersion of the prosthesis in 0.15% Triclosan solution; (3) brushing of the palate and immersion of the prostheses in lactose monohydrate; (4) brushing the palate with citric acid and immersing the prosthesis in lactose monohydrate. The response variables will be: heart rate variability and alteration of blood pressure (systemic level), remission of Denture-related Stomatitis, removal of biofilm, reduction of microbial load (CFU), mouth and prosthesis odor level, expression of MUC1, proinflammatory cytokines, C-reactive protein level - CRP, viscosity, pH and salivary flow (locally); qualitative analysis patient-centred will also be held. Measurements will be performed in the Baseline and ten days after the interventions. The results obtained will be submitted to the pertinent statistical analysis with a level of significance of 0.05. Discussion. This study will provide a guideline of clinical practice regarding the use of hygiene protocols in the treatment of oral diseases (DS) mediated by biofilm. Also, it may provide evidence of correlation of oral manifestation with cardiac risk.


2019 ◽  
Author(s):  
Adriana Barbosa Ribeiro ◽  
Camila Borba de Araújo ◽  
Frank Lucarini Bueno ◽  
Luiz Eduardo Silva ◽  
Rubens Fazan-Junior ◽  
...  

Abstract Background The Denture-related stomatitis (DS) is a chronic multifactorial inflammation, strongly related to the presence of the biofilm. This oral condition has recently been correlated with deleterious cardiovascular alterations. The potential effect of hygiene protocols in the control of DS and Randomized clinical trials that address this oral condition with cardiovascular complications are necessary for clinical decision-making. Material/design A clinical trial, randomized, double-blind, of parallel groups, will be conducted in Brazil and the sample will be composed of 100 total edentulous individuals bi-maxillary, users of at least maxillary complete dentures, diagnosed with DS that will be allocated according to the different hygiene protocols: (1) brushing of the palate and immersion of the prosthesis in 0.25% sodium hypochlorite solution (positive control); (2) brushing of the palate and immersion of the prosthesis in 0.15% Triclosan solution; (3) brushing of the palate and immersion of the prostheses in lactose monohydrate; (4) brushing the palate with citric acid and immersing the prosthesis in lactose monohydrate. The response variables will be: heart rate variability and alteration of blood pressure (systemic level), remission of Denture-related Stomatitis, removal of biofilm, reduction of microbial load (CFU), mouth and prosthesis odor level, expression of MUC1, proinflammatory cytokines, C-reactive protein level - CRP, viscosity, pH and salivary flow (locally). Measurements will be performed in the Baseline and ten days after the interventions. The results obtained will be submitted to the pertinent statistical analysis with a level of significance of 0.05. Discussion This study will provide a guideline of clinical practice regarding the use of hygiene protocols in the treatment of oral diseases mediated by biofilm. Also, it may provide evidence of correlation of oral manifestation with cardiac risk.


Critical Care ◽  
2020 ◽  
Vol 24 (1) ◽  
Author(s):  
Adam Flaczyk ◽  
Rachel P. Rosovsky ◽  
Clay T. Reed ◽  
Brittany K. Bankhead-Kendall ◽  
Edward A. Bittner ◽  
...  

Abstract Critically ill patients with COVID-19 are at increased risk for thrombotic complications which has led to an intense debate surrounding their anticoagulation management. In the absence of data from randomized controlled clinical trials, a number of consensus guidelines and recommendations have been published to facilitate clinical decision-making on this issue. However, substantive differences exist between these guidelines which can be difficult for clinicians. This review briefly summarizes the major societal guidelines and compares their similarities and differences. A common theme in all of the recommendations is to take an individualized approach to patient management and a call for prospective randomized clinical trials to address important anticoagulation issues in this population.


2021 ◽  
Author(s):  
Nana Han ◽  
◽  
Yang Fang ◽  
Guozhen Zhao ◽  
Bo Ji

Review question / Objective: According to the current randomized clinical trials (RCT) of acupuncture therapy for Alzheimer's disease (AD), to evaluate their methodology, the quality of evidence and the report are evaluated and summarize evidence of important outcomes of randomized clinical trials. We aim to provide accurate clinical decision-making for acupuncture treatment of Alzheimer's disease. Condition being studied: According to the current randomized clinical trials (RCT) of acupuncture therapy for Alzheimer's disease (AD), to evaluate their methodology, the quality of evidence and the report are evaluated and summarize evidence of important outcomes of randomized clinical trials. We aim to provide accurate clinical decision-making for acupuncture treatment of Alzheimer's disease.


2003 ◽  
Vol 29 (5) ◽  
pp. 969-981 ◽  
Author(s):  
John Grabowski ◽  
Howard Rhoades ◽  
Angela Stotts ◽  
Katherine Cowan ◽  
Charles Kopecky ◽  
...  

1999 ◽  
Vol 14 (2) ◽  
pp. 93-100
Author(s):  
J. Catteau ◽  
C. Cyran ◽  
R. Bordet ◽  
C.E. Thomas ◽  
B.A. Dupuis

SummaryThe goal of this prospective investigation was to study the course and the quality of patient-psychiatrist relationships during phase II / phase III clinical trials of antidepressant medication prescribed for depressive disorders. All patients who participated in the clinical trials (and subsequently in this survey) signed written informed consent statements and were subject to random double blind treatment assignment. Retrospective analysis of 118 investigations was carried out, and the patients involved were questioned concerning their experiences and impressions during and after the study. Data show that the outcome of clinical trials of antidepressant drugs are not a function of pre-existing good patient-psychiatrist relationships. On the other hand, no effects on the patient-psychiatrist relationship were found as a result of the experimental procedure, and it can be concluded that no detrimental effects on future patient-psychiatrist relationships were incurred.


2018 ◽  
Vol 25 ◽  
pp. 59 ◽  
Author(s):  
J.M. Rothenstein ◽  
N. Chooback

The treatment of advanced non-small-cell lung cancer (nsclc) has undergone a paradigm shift since the early 2000s. The identification of molecular subtypes of the disease, based on oncogenic drivers, has led to the development of personalized medicine and the ability to deliver molecularly targeted therapies to patients. In the 10 years that have elapsed since the discovery of the ALK gene in a patient with nsclc, several active drugs have moved rapidly from bench to bedside, and multiple others are currently in clinical trials. Those developments have led to important improvements in patient outcomes, while simultaneously raising key questions about the optimal treatment for ALK-positive nsclc. The inevitable emergence of resistance to alk-directed therapy is central to ongoing research and daily clinical practice for affected patients. In the present review, we highlight the current treatment landscape, the available and emerging clinical trials, and the evolving clinical decision-making in ALK-positive nsclc, with a focus on Canadian practice.


2020 ◽  
Vol 14 ◽  
pp. 117954682095341 ◽  
Author(s):  
Todd C Villines ◽  
Mark J Cziraky ◽  
Alpesh N Amin

Real-world evidence (RWE) provides a potential rich source of additional information to the body of data available from randomized clinical trials (RCTs), but there is a need to understand the strengths and limitations of RWE before it can be applied to clinical practice. To gain insight into current thinking in clinical decision making and utility of different data sources, a representative sampling of US cardiologists selected from the current, active Fellows of the American College of Cardiology (ACC) were surveyed to evaluate their perceptions of findings from RCTs and RWE studies and their application in clinical practice. The survey was conducted online via the ACC web portal between 12 July and 11 August 2017. Of the 548 active ACC Fellows invited as panel members, 173 completed the survey (32% response), most of whom were board certified in general cardiology (n = 119, 69%) or interventional cardiology (n = 40, 23%). The survey results indicated a wide range of familiarity with and utilization of RWE amongst cardiologists. Most cardiologists were familiar with RWE and considered RWE in clinical practice at least some of the time. However, a significant minority of survey respondents had rarely or never applied RWE learnings in their clinical practice, and many did not feel confident in the results of RWE other than registry data. These survey findings suggest that additional education on how to assess and interpret RWE could help physicians to integrate data and learnings from RCTs and RWE to best guide clinical decision making.


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