Effectiveness of Resin-Based Sealants with and without Fluoride Placed in a High Caries Risk Population: Multicentric 2-Year Randomized Clinical Trial

2018 ◽  
Vol 52 (4) ◽  
pp. 312-322 ◽  
Author(s):  
Michèle Muller-Bolla ◽  
Fréderic Courson ◽  
Laurence Lupi-Pégurier ◽  
Corinne Tardieu ◽  
Shrisha Mohit ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Retention Rate ◽  
Intervention Group ◽  
Assessment System ◽  
Caries Detection ◽  
Control Group ◽  
Caries Risk ◽  
High Caries Risk

A split-mouth randomized clinical trial was carried out to assess the effectiveness of sealants in preventing carious ICDAS (International Caries Detection and Assessment System) 3–6 lesions within a 2-year follow-up. We evaluated the effectiveness of 2 types of resin-based sealants, with and without fluoride, their retention rates, and the caries risk factors related to their outcomes. The study included 663 tooth pairs in 400 children (aged 5–15 years) considered to be at high individual caries risk (ICR) and presenting permanent molars free of caries or affected by ICDAS 1–2 lesions. In the first randomization, molars were either randomized to the treatment group receiving a dental sealant or the control group (nontreatment), and in the second randomization the sealant material to be used in the intervention group was selected. Uni- and multivariate Cox proportional hazard models were employed. At the 2-year follow-up, 483 tooth pairs were assessed: sealed molars had 83% (adjusted HR = 0.17; 95% CI: 0.15–0.20) less risk of developing ICDAS 3–6 lesions than molars without sealant. The magnitude of the protective effect was lower among teeth with ICDAS 1–2 lesions or with occlusal deep fissures than without. If the total retention rate of sealants was 70% at 2 years, sealant loss was not associated with the risk of caries (HR = 1.29, 95% CI: 0.92–1.79, p = 0.14). Sealants allow the prevention of new ICDAS 3–6 lesions or progression of noncavitated carious lesions in children at high ICR, and the effect of the sealant was similar regardless of whether it contained fluoride or not.

scholarly journals Home visit improves knowledge, self-care and adhesion in heart failure: randomized Clinical Trial HELEN-I

2013 ◽  
Vol 21 (spe) ◽  
pp. 20-28 ◽  
Author(s):  
Cláudia Motta Mussi ◽  
Karen Ruschel ◽  
Emiliane Nogueira de Souza ◽  
Alexandra Nogueira Mello Lopes ◽  
Melina Maria Trojahn ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Self Care ◽  
Home Visits ◽  
Decompensated Heart Failure ◽  
Control Group ◽  
Phone Calls

OBJECTIVE: To verify the effect of an educative nursing intervention composed of home visits and phone calls on patients' knowledge about the disease, self-care and adhesion to the treatment. METHODS: Randomized clinical trial with patients with recent hospitalization caused by decompensated heart failure. There were two groups: the intervention group, which has received four home visits and four phone calls to reinforce the guidelines during six months of follow up; and the control group, which has received conventional follow up with no visits or phone calls. RESULTS: Two hundred patients were randomized (101 in the intervention group and 99 in the control group). After six months, a significant improvement was observed in self-care and knowledge about the disease in the intervention group (P=0.001 and P<0.001), respectively; the adhesion to the treatment, measured and compared between the groups, was significantly higher in the intervention group (P=0.001). CONCLUSION: the strategy of home visits to patients who were recently hospitalized with decompensated heart failure was effective in improving the outcomes assessed and its implementation deserves to be considered in Brazil aiming at avoiding unplanned hospitalizations. NCT-01213862

The effectiveness of a program of physical activity and diet to modify cardiovascular risk factors in patients with severe mental illness after 3-month follow-up: CAPiCOR randomized clinical trial

2015 ◽  
Vol 30 (8) ◽  
pp. 1028-1036 ◽  
Author(s):  
R. Masa-Font ◽  
M.I. Fernández-San-Martín ◽  
L.M. Martín López ◽  
A.M. Alba Muñoz ◽  
S. Oller Canet ◽  
...  
Keyword(s):  
Physical Activity ◽  
Clinical Trial ◽  
Mental Illness ◽  
Severe Mental Illness ◽  
Randomized Clinical Trial ◽  
Dietary Habits ◽  
Intervention Group ◽  
Control Group ◽  
Laboratory Parameters

AbstractBackgroundThe aim of this randomized clinical trial follow-up at three months was to evaluate the effectiveness of an educational intervention with a focus on diet and physical activity (PA) to change the amount of PA, body mass index (BMI) and the waist circumference (WC) in patients with severe mental illness.MethodsWe recruited 332 outpatients with severe mental disorders undergoing treatment with antipsychotic medication from Mental Healthcare Centers of Barcelona. They were randomly assigned to an intervention or a control group. The patients in the intervention group participated in a group PA and diet educational program. The blinded measurements at 0 and 3 months were: the level of PA (IPAQ questionnaire), BMI, WC, blood pressure, dietary habits (PREDIMED questionnaire), quality of life (SF-36 questionnaire) and laboratory parameters (cholesterol, triglycerides, glucose).ResultsThe average age was 46.7 years and 55% were males. Schizophrenia had been diagnosed in 67.1% of them. At 3 months, the average weekly walking METs rose significantly in the IG 266.05 METs (95%CI: 16.86 to 515.25; P = 0.036). The total MET average also rose although not significantly: 191.38 METs (95%CI: 1.38 to 381.38; P = 0.086). However, the BMI decreased significantly more in the CG, by 0.26 kg/m2 (95%CI: 0.02 to 0.51; P = 0.038), than in the IG. There were no significant differences in the WC.ConclusionsThe short-term results suggest that the intervention increases the level of PA, but does not improve physical or laboratory parameters.Trial registrationClinicaltrials.gov NCT01729650 (effectiveness of a physical activity and diet program in patients with psychotic disorder [CAPiCOR]).

Effects of a diuretic adjustment algorithm protocol on heart failure admissions: A randomized clinical trial

2021 ◽  
pp. 1357633X2110096
Author(s):  
Maria KEF Feijó ◽  
Karen Brasil Ruschel ◽  
Daniela Bernardes ◽  
Eduarda B Ferro ◽  
Luis E Rohde ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Heart Association ◽  
Functional Class ◽  
Emergency Department Visits ◽  
Control Group ◽  
Point Change ◽  
Clinical Instability

Introduction The aim of this study was to evaluate the effectiveness of a diuretic adjustment algorithm (DAA) in maintaining clinical stability and reducing HF readmissions using telemonitoring Technologies. Methods Randomized clinical trial of patients with an indication for furosemide dose adjustment during routine outpatient visits. In the intervention group (IG), the diuretic dose was adjusted according to the DAA and the patients received telephone calls for 30 days. In the control group (CG), the diuretic dose was adjusted by a physician at baseline only. Co-primary outcomes were hospital readmission and/or emergency department visits due to decompensated HF within 90 days, and a 2-point change in the Clinical Congestion Score and/or a deterioration in New York Heart Association functional class within 30 days. Results A total of 206 patients were included. Most patients were male ( n=119; 58%), with a mean age of 62 (SD 13) years. Four patients (2%) in the IG and 14 (7%) in the CG were hospitalized for HF (odds ratio (OR) 0.31 (0.10–0.91); p=0.04). Multivariate analysis showed a reduction of 67% in readmissions and/or emergency department visits due to decompensated HF in the IG compared with the CG (95% CI 0.13–0.88; p=0.027). Regarding the combined outcome of HF readmission and/or emergency department visits or clinical instability, the IG had 20% fewer events than the CG within 30 days (IG: n=48 (23%), CG: n=70 (34%); OR 0.80 (0.63–0.93); p=0.03). Discussion Using DAA improved the combined outcome in these outpatients, with favorable and significant results that included a reduction in HF admissions and in clinical instability. (NCT02068937)

Effect of prenatal recommendations of Traditional Persian Medicine on obstetric outcomes: a randomized clinical trial

2018 ◽  
Vol 15 (3) ◽  
Author(s):  
Mansoor Keshavarz ◽  
Maryam Kashanian ◽  
Soodabeh Bioos ◽  
Yasaman Vazani
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Active Phase ◽  
Obstetric Outcomes ◽  
Control Group ◽  
Control Groups ◽  
Persian Medicine ◽  
Traditional Persian Medicine ◽  
And Control

Abstract Background Traditional Persian Medicine (TPM) is an ancient medical system that provides suggestions to improve the health of mothers and children during pregnancy and labor. Persian physicians believed that these instructions made labor easier, safer, and less painful. Methods The present randomized clinical trial was conducted among women at 33–38 weeks of pregnancy in Tehran, Iran. TPM instructions consisted of diet, bathing, and application of oil from the 38th week of pregnancy to the onset of labor. The primary outcome was the duration of the active phase of labor. Results The mean duration of the active phase was 331.60 ± 151.48 min for the intervention group and 344.40 ± 271.46 min for the control groups, but it was not statistically significant. The active phase was significantly shorter in women who had better compliance (p=0.03). The need for oxytocin augmentation was 53.3% in the control group and 38.5% in the intervention group (p=0.17). The rate of perineal infection was 13% in the control group and 0% in the intervention group (p=0.11). Conclusions The active phase was not different in the intervention and control groups, but it was shorter in compliant women. It is possible that prolonged use of these recommendations in combination with a sitz baths and a larger sample size could result in more significant outcomes.

scholarly journals Effectiveness of a home care teaching program for prostatectomized patients: a randomized controlled clinical trial

2019 ◽  
Vol 53 ◽  
Author(s):  
Luciana Regina Ferreira da Mata ◽  
Cissa Azevedo ◽  
Mariana Ferreira Vaz Gontijo Bernardes ◽  
Tânia Couto Machado Chianca ◽  
Maria da Graça Pereira ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Home Care ◽  
Self Efficacy ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Teaching Program ◽  
Significant Difference ◽  
The Times

ABSTRACT Objective: To evaluate the effectiveness of a teaching program for hospital discharge of patients submitted to radical prostatectomy based on the self-efficacy construct of the Cognitive Social Theory. Method: A controlled clinical trial carried out on a 2-month follow-up of 68 prostatectomized men randomized into intervention group (n = 34) and control (n = 34). The intervention group received routine guidance from the service plus the teaching program. The control group only received routine guidance from the service. The data collection instruments were: sociodemographic and clinical questionnaire, self-efficacy scale, hospital depression and anxiety scale, household care knowledge questionnaire, and an item on satisfaction with a score of 1 to 5. Results: There was a significant difference between the intragroups for satisfaction (p<0.001) and knowledge (p<0.001) of the pre-test to the post-test. In the intervention group, there were significant changes between the times for anxiety (p=0.011) and knowledge (p<0.001). Conclusion: The teaching program with a combination of oral guidance, written instruction and telephone follow-up was effective in improving knowledge about home care and personal satisfaction. Brazilian Registry of Clinical Trials: RBR-5n95rm.

scholarly journals The Effect of Support Surfaces on the Incidence of Pressure Injuries in Critically Ill Patients: A Randomized Clinical Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Wesley Henrique Bueno de Camargo ◽  
Rita de Cassia Pereira ◽  
Marcos T. Tanita ◽  
Lidiane Heko ◽  
Isadora C Grion ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Intervention Group ◽  
Control Group ◽  
Support Surface ◽  
Intention To Treat ◽  
Support Surfaces ◽  
Effect Of Support

Purpose. To analyze whether a viscoelastic mattress support surface can reduce the incidence of stage 2 pressure injuries compared to a standard hospital mattress with pyramidal overlay in critically ill patients. Method. A randomized clinical trial with intention-to-treat analysis was carried out recruiting patients with Braden scale ≤14 on intensive care unit admission from April 2016 to April 2017. Patients were allocated into two groups: intervention group (viscoelastic mattress) and control group (standard mattress with pyramidal overlay). The level of significance adopted was 5%. Results. A total of 62 patients were included in the study. There was a predominance of males (53%) and the mean age was 67.9 (SD 18.8) years. There were no differences in clinical or severity characteristics between the patients in the control group and the intervention group. Pressure injuries occurred in 35 patients, with a median time of 7 days (ITQ 4–10) from admission. The frequency of pressure injuries was higher in the control group (80.6%) compared to the intervention group (32.2%; p<0.001). Conclusions. Viscoelastic support surfaces reduced the incidence of pressure injuries in moderate or higher risk critically ill patients when compared to pyramidal support surfaces.

scholarly journals Acupuncture for Olfactory Dysfunction in Infected COVID-19 Patients: Study Protocol for a Single Blind, Randomized, Sham-Controlled Clinical Trial

2021 ◽  
Author(s):  
Linda LD Zhong ◽  
Chi-Fung CHOY ◽  
Hung-Wai CHO ◽  
Yi-Ping WONG ◽  
Alan Yat-Lun WONG ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intervention Group ◽  
Sham Acupuncture ◽  
Olfactory Dysfunction ◽  
Secondary Outcome ◽  
Control Group ◽  
Common Symptom ◽  
Real Acupuncture ◽  
Single Blind

Abstract Background: Olfactory dysfunction (OD) was recognized as one of common symptom of COVID-19. OD, defined as the reduced or distorted ability to smell during sniffing (orthonasal olfaction) and may represent one of early symptoms in the clinical course of COVID-19 infection. A large online questionnaire-based survey found that some of post COVID-19 patients showed no improvement at one month after they were discharged from hospital. Therefore, this clinical trial is designed to explore the efficacy of acupuncture for OD in infected COVID-19 patients and to determine whether acupuncture could have benefits than sham acupuncture for OD in post- COVID-19 patients.Methods: This is a single blind, randomized controlled, cross over trial. We plan to recruit forty post-COVID-19 patients who are presenting with smell loss or smell distortions more than one month. Qualified patients will be randomly allocated into the intervention group (real acupuncture) or the control group (sham acupuncture) in a 1:1 ratio. Each patient will receive 8 sessions of treatment over 4 week (Cycle 1), and 2-week follow-up. After the follow-up, the control group will be conducted with real acupuncture for another 4 weeks (Cycle 2), and the real acupuncture group will be conducted with the 4-week sham acupuncture. The primary outcomes are the scores change on the questionnaire of olfactory functioning and olfaction related quality of life at weeks 6, 8, 12 and 14 from the baseline. Secondary outcome is the change on the Olfactory Test score at the week 6 and 12 from the baseline measured by using the Traditional Chinese version of the University of Pennsylvania Smell Identification Test (UPSIT-TC).Discussion: The results of this trial will help to determine the effectiveness of acupuncture for OD in post-COVID-19 Patients. This may provide a new treatment option for patients.Trial registration: ClinicalTrials.gov, NCT04959747, Registered on July 13, 2021.

scholarly journals The Antimicrobial Effect of Pomegranate Peel Extract versus Chlorhexidine in High Caries Risk Individuals Using Quantitative Real-Time Polymerase Chain Reaction: A Randomized Triple-Blind Controlled Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-14
Author(s):  
Benoy Jacob ◽  
Nivedhitha Malli Sureshbabu ◽  
Manish Ranjan ◽  
Aishwarya Ranganath ◽  
Riluwan Siddique
Keyword(s):  
Clinical Trial ◽  
Control Group ◽  
Caries Risk ◽  
Chain Reaction ◽  
Pomegranate Peel ◽  
Oral Rinse ◽  
High Caries Risk ◽  
Polymerase Chain ◽  
Pomegranate Peel Extract ◽  
Peel Extract

The aim of the present study was to compare the antibacterial effectiveness of chlorhexidine and PPE oral rinse on S. mutans, Lactobacilli, and Veillonella, in clinical salivary samples of patients with advanced stages of dental caries at baseline and two and four weeks with PCR technique. This triple-blind randomized clinical trial involved 60 high caries risk adult patients, 19–59 years of age, randomly allocated into two groups of 30 subjects each. The intervention group received pomegranate peel extract mouthwash, whereas the control group received chlorhexidine mouthwash. Unstimulated pooled saliva was collected from the floor of the mouth before and after the intervention. The quantitative real-time polymerase chain reaction was employed to analyze the bacterial copies of each salivary sample at baseline and two and four weeks. The significance level was fixed at 5% (α = 0.05). Overall comparison of antimicrobial effectiveness across both groups revealed insignificant outcomes. The control group evinced a significant reduction in S. mutans between a specific time, i.e., baseline and 4 weeks ( p = 0.043 ). PPE oral rinse as a natural product or ecological alternative was effective in disrupting activity across all microorganisms tested in this triple-blind RCT; however, the nutraceutical, when compared to chlorhexidine, was not as effective against S. mutans.

scholarly journals Effect of Mindfulness Sessions on Chronic Fatigue Syndrome and Job Satisfaction of Nurses: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Nasrin Bonakdari ◽  
Nadereh Mohammadi ◽  
Mohammad Reza Taghvizadeh Yazdi ◽  
Reza Norouzadeh ◽  
Mohammad Abbasinia ◽  
...  
Keyword(s):  
Job Satisfaction ◽  
Clinical Trial ◽  
Chronic Fatigue Syndrome ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Clinical Trial Design ◽  
Well Being ◽  
Chronic Fatigue ◽  
Control Group ◽  
Fatigue Syndrome

Abstract Background: Nursing is considered a stressful profession, so nurses are at higher risk of physical and mental illness. Mindfulness is an important concept for nursing with practical implications for nurse well-being, development, and quality nursing care sustainability.Objectives: This study identified mindfulness sessions' effect on nurses' chronic fatigue syndrome(CFS) and job satisfaction )JS.(Methods: A randomized clinical trial design was conducted on 80 nurses to intervention and control groups. The intervention in the intervention group was eight mindfulness sessions training, and the control group had no intervention. Nurses' CFS and JS were assessed using the Minnesota Satisfaction Questionnaire and The Multidimensional Fatigue Inventory.Results: After implementing a mindfulness-based stress reduction program, the intervention group nurses reported lower CFS and higher JS than the control group(p<0.005). Conclusion: The findings of this study indicate the effectiveness of mindfulness programs on improving nurses' chronic fatigue and JS. Since CFS and job dissatisfaction are two disturbing elements for nurses' optimal performance in professional and personal life, this study can recommend the implementation of mindfulness exercises as a routine, operational and uncomplicated program in nurses.

scholarly journals The impact of social network-based nursing care training on oncology nurses’ occupational stress and self-efficacy: Non-randomized clinical trial

2020 ◽  
Author(s):  
Mehri Bozorgnejad ◽  
Tahereh Najafi Ghezeljeh ◽  
Hamid Haghani ◽  
Amin Iri
Keyword(s):  
Clinical Trial ◽  
Social Network ◽  
Randomized Clinical Trial ◽  
Occupational Stress ◽  
Nursing Care ◽  
Self Efficacy ◽  
Intervention Group ◽  
Oncology Nurses ◽  
Control Group ◽  
Care Training

Background & Aim: Inadequate clinical knowledge is one of the leading causes of stress and low occupational self-efficacy among nurses. Nursing training can enhance self-efficacy and reduce stress. Therefore, this study aimed to determine the effect of social network-based nursing care training, using mobile phones, occupational stress, and self-efficacy among oncology nurses. Methods & Materials: This non-randomized clinical trial study was conducted on 78 nurses working in oncology wards of two selected educational hospitals in Tehran in 2018. The nurses entered the study through available sampling. They were randomly assigned to two groups of control and intervention. Nursing care training in chemotherapy was provided to the nurses in the intervention group through a mobile phone social network for four weeks. On the other hand, the nurses in the control group were provided with the routine training pamphlets and brochures in the oncology ward. The nurses’ stress level was examined using an expanded nursing stress scale and their occupational stress was measured using a job self-efficacy questionnaire once before the intervention and then one month after the intervention. The data analysis was then performed according to independent t-test, paired t-test, and chi-square using SPSS software version 16. Results: The two groups were homogeneous in terms of age, gender, work experience, and education. There was no significant difference in terms of occupational stress and self-efficacy between the two groups before the intervention (P<0.05). The changes in the occupational stress score were statistically significant (P<0.05) among the nurses in the intervention group. Moreover, the changes in the occupational self-efficacy score were statistically significant among nurses in the intervention group compared to the control group (P<0.05). Conclusion: Educational intervention through social networking can lead to a reduction of occupational stress and an increase in self-efficacy among oncology nurses. Reducing stress and increasing nurses’ occupational self-efficacy will improve their performance at the bedside. This is an easy, inexpensive, and effective training method that can be used by health managers and educators to enhance employee’s performance.

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