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Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trial.

ABSTRACT: INTRODUCTION:In-office tooth whitening treatment using violet light emited diode (LED) (405?nm) is a novel bleaching method that causes less sensitivity while offering the same effectiveness as the gold standard (35% hydrogen peroxide, H2O2). This study describes a protocol for the first randomised controlled clinical trial to compare the effects of the two methods. METHODS AND ANALYSIS:Eighty patients will be divided into four groups: G1 violet LED; G2 violet LED +35%?carbamide peroxide; G3 35% H2O2 and G4 violet LED +gingivoplasty. Colour will be measured at baseline, immediately after the first session and at the 15 and 180?days follow-up using the Vita Classical and the digital Easyshade V spectrophotometer (Vita, Zahnfabrik, Germany). Sensitivity after whitening will be measured using the Visual Analogue Scale at baseline and at each session in all groups and in all follow-ups. The tissue removed during gingivoplasty (G4) will be submitted to immunohistochemical analysis for the determination of inflammatory changes caused by violet LED. The Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) will be evaluated before, as well as at established time point controls. The results will be expressed as mean and SD values. After determining the normality of the data, a one-way repeated-measures analysis of variance will be used for the comparison of data with normal distribution and the Kruskal-Wallis test will be used for data with non-normal distribution. A p<0.05?will be considered indicative of statistical significance. After determining the normality of the data, the Kruskal-Wallis test will be used for non-parametric data. Multivariate analysis of variance (MANOVA) and the Wilcoxon test will be used for comparing data from the PIDAQ. ETHICS AND DISSEMINATION:This protocol has been approved by the Human Research Ethics Committee of UniversidadeNove de Julho (certificate: 2.034.518). The findings will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER:NCT03192852; Pre-results.

SUBMITTER: Santos AECGD

PROVIDER: S-EPMC6129043 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trial.

Santos Ana Eliza Castanho Garrini Dos AECGD Bussadori Sandra Kalil SK Pinto Marcelo Mendes MM Pantano Junior Dácio Antonio DA Brugnera Aldo A Zanin Fátima Antonia Aparecida FAA Rodrigues Maria Fernanda Setúbal Destro MFSD Motta Lara Jansiski LJ Horliana Anna Carolina Ratto Tempestini ACRT

BMJ open 20180904 9

<h4>Introduction</h4>In-office tooth whitening treatment using violet light emited diode (LED) (405 nm) is a novel bleaching method that causes less sensitivity while offering the same effectiveness as the gold standard (35% hydrogen peroxide, H<sub>2</sub>O<sub>2</sub>). This study describes a protocol for the first randomised controlled clinical trial to compare the effects of the two methods.<h4>Methods and analysis</h4>Eighty patients will be divided into four groups: G1 violet LED; G2 viole ...[more]

PMID: 30181185

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Project description:Excessive sitting time is a risk factor for cardiovascular disease mortality and morbidity independent of physical activity. This aim of this study was to evaluate the impact of a sit-stand workstation on sitting time, and vascular, metabolic and musculoskeletal outcomes in office workers, and to investigate workstation acceptability and feasibility.A two-arm, parallel-group, individually randomised controlled trial was conducted in one organisation. Participants were asymptomatic full-time office workers aged ?18 years. Each participant in the intervention arm had a sit-stand workstation installed on their workplace desk for 8 weeks. Participants in the control arm received no intervention. The primary outcome was workplace sitting time, assessed at 0, 4 and 8 weeks by an ecological momentary assessment diary. Secondary behavioural, cardiometabolic and musculoskeletal outcomes were assessed. Acceptability and feasibility were assessed via questionnaire and interview. ANCOVA and magnitude-based inferences examined intervention effects relative to controls at 4 and 8 weeks. Participants and researchers were not blind to group allocation.Forty-seven participants were randomised (intervention n?=?26; control n?=?21). Relative to the control group at 8 weeks, the intervention group had a beneficial decrease in sitting time (-80.2 min/8-h workday (95 % CI?=?-129.0, -31.4); p?=?0.002), increase in standing time (72.9 min/8-h workday (21.2, 124.6); p?=?0.007) and decrease in total cholesterol (-0.40 mmol/L (-0.79, -0.003); p?=?0.049). No harmful changes in musculoskeletal discomfort/pain were observed relative to controls, and beneficial changes in flow-mediated dilation and diastolic blood pressure were observed. Most participants self-reported that the workstation was easy to use and their work-related productivity did not decrease when using the device. Factors that negatively influenced workstation use were workstation design, the social environment, work tasks and habits.Short-term use of a feasible sit-stand workstation reduced daily sitting time and led to beneficial improvements in cardiometabolic risk parameters in asymptomatic office workers. These findings imply that if the observed use of the sit-stand workstations continued over a longer duration, sit-stand workstations may have important ramifications for the prevention and reduction of cardiometabolic risk in a large proportion of the working population.ClinicalTrials.gov NCT02496507 .

Project description:Multiple sclerosis is a chronic neurological condition usually starting in early adulthood and regularly leading to severe disability. Immunotherapy options are growing in number and complexity, while costs of treatments are high and adherence rates remain low. Therefore, treatment decision-making has become more complex for patients. Structured decision coaching, based on the principles of evidence-based patient information and shared decision-making, has the potential to facilitate participation of individuals in the decision-making process. This cluster randomised controlled trial follows the assumption that decision coaching by trained nurses, using evidence-based patient information and preference elicitation, will facilitate informed choices and induce higher decision quality, as well as better decisional adherence.The decision coaching programme will be evaluated through an evaluator-blinded superiority cluster randomised controlled trial, including 300 patients with suspected or definite relapsing-remitting multiple sclerosis, facing an immunotherapy decision. The clusters are 12 multiple sclerosis outpatient clinics in Germany. Further, the trial will be accompanied by a mixed-methods process evaluation and a cost-effectiveness study. Nurses in the intervention group will be trained in shared decision-making, coaching, and evidence-based patient information principles. Patients who meet the inclusion criteria will receive decision coaching (intervention group) with up to three face-to-face coaching sessions with a trained nurse (decision coach) or counselling as usual (control group). Patients in both groups will be given access to an evidence-based online information tool. The primary outcome is 'informed choice' after six months, assessed with the multi-dimensional measure of informed choice including the sub-dimensions risk knowledge (questionnaire), attitude concerning immunotherapy (questionnaire), and immunotherapy uptake (telephone survey). Secondary outcomes include decisional conflict, adherence to immunotherapy decisions, autonomy preference, planned behaviour, coping self-efficacy, and perceived involvement in coaching and decisional encounters. Safety outcomes are comprised of anxiety and depression and disease-specific quality of life.This trial will assess the effectiveness of a new model of patient decision support concerning MS-immunotherapy options. The delegation of treatment information provision from physicians to trained nurses bears the potential to change current doctor-focused practice in Germany.Current Controlled Trials (identifier: ISRCTN37929939 ), May 27, 2014.

Project description:There are no universally accepted guidelines for the follow-up of individuals with cutaneous melanoma. Furthermore, to date, there have been no randomised controlled trials of different models of melanoma follow-up care. This randomised controlled trial was conducted to evaluate the effects of GP-led melanoma follow-up on patient satisfaction, follow-up guideline compliance, anxiety and depression, as well as health status.A randomised controlled trial of GP-led follow-up of cutaneous melanoma was conducted over a period of 1 year with assessment by self-completed questionnaires and review of general practice-held medical records at baseline and 12 months later. It took place in 35 general practices in North-east Scotland. Subjects were 142 individuals (51.4% women 48.6% men; mean (s.d.) age 59.2 (15.2) years previously treated for cutaneous melanoma and free of recurrent disease. The intervention consisted of protocol-driven melanoma reviews in primary care, conducted by trained GPs and supported by centralised recall, rapid access pathway to secondary care and a patient information booklet. The main outcome measure was patient satisfaction measured by questionnaire. Secondary outcomes were adherence to guidelines, health status measured by Short Form-36 and the Hospital Anxiety and Depression Scale.There were significant improvements in 5 out of 15 aspects of patient satisfaction during the study year in those receiving GP-led melanoma follow-up (all P<or=0.01). The intervention group was significantly more satisfied with 7 out of 15 aspects of care at follow-up after adjustment for potential confounders. There was significantly greater adherence to guidelines in the intervention group during the study year. There was no significant difference in health status or anxiety and depression between intervention and control groups at either baseline or outcome.GP-led follow-up is feasible, engenders greater satisfaction in those patients who receive it, permits closer adherence to guidelines and does not result in adverse effects on health status or anxiety and depression when compared with traditional hospital-based follow-up for melanoma.

Project description:BackgroundAdvanced resuscitation skills training is an important and enjoyable part of medical training, but requires small group instruction to ensure active participation of all students. Increases in student numbers have made this increasingly difficult to achieve.MethodsA single-blind randomised controlled trial of peer-led vs. expert-led resuscitation training was performed using a group of sixth-year medical students as peer instructors. The expert instructors were a senior and a middle grade doctor, and a nurse who is an Advanced Life Support (ALS) Instructor.A power calculation showed that the trial would have a greater than 90% chance of rejecting the null hypothesis (that expert-led groups performed 20% better than peer-led groups) if that were the true situation. Secondary outcome measures were the proportion of High Pass grades in each groups and safety incidents.The peer instructors designed and delivered their own course material. To ensure safety, the peer-led groups used modified defibrillators that could deliver only low-energy shocks.Blinded assessment was conducted using an Objective Structured Clinical Examination (OSCE). The checklist items were based on International Liaison Committee on Resuscitation (ILCOR) guidelines using Ebel standard-setting methods that emphasised patient and staff safety and clinical effectiveness.The results were analysed using Exact methods, chi-squared and t-test.ResultsA total of 132 students were randomised: 58 into the expert-led group, 74 into the peer-led group. 57/58 (98%) of students from the expert-led group achieved a Pass compared to 72/74 (97%) from the peer-led group: Exact statistics confirmed that it was very unlikely (p = 0.0001) that the expert-led group was 20% better than the peer-led group.There were no safety incidents, and High Pass grades were achieved by 64 (49%) of students: 33/58 (57%) from the expert-led group, 31/74 (42%) from the peer-led group. Exact statistics showed that the difference of 15% meant that it was possible that the expert-led teaching was 20% better at generating students with High Passes.ConclusionsThe key elements of advanced cardiac resuscitation can be safely and effectively taught to medical students in small groups by peer-instructors who have undergone basic medical education training.

Project description:IntroductionMany stroke survivors have unmet psychosocial needs during the recovery phase following a stroke. There is emerging evidence that peer support interventions may play a valuable role in managing stroke. However, evidence regarding the effectiveness of peer support interventions on the psychosocial outcomes of stroke survivors is uncertain. This study aims to develop a nurse-led peer support intervention for stroke survivors based on the Person-Environment-Occupation-Performance Model and evaluate its effects on the psychosocial outcomes of stroke survivors.Methods and analysisThis is an assessor-blinded two-arm randomised controlled trial. A convenience sample of 120 stroke survivors will be recruited from two community centres and one rehabilitation unit in Yangzhou, a medium-sized city in eastern China, with 60 participants each in the intervention and control groups. The participants allocated to the intervention group will receive the nurse-led peer support intervention, which includes 6 weekly peer support sessions facilitated by a nurse and at least one peer facilitator. Participants randomised to the control group will receive the same dose of interpersonal interaction as intervention participants, including weekly individual face-to-face session for 6 weeks. The primary outcomes are social participation and participation self-efficacy. The secondary outcomes are psychosocial distress, social support, stigma towards disease, self-efficacy in managing chronic conditions and quality of life. Data will be collected at baseline, immediately after the intervention and 3 months after the intervention. A process evaluation will be conducted qualitatively and quantitively to examine the mechanism by which the intervention impacts the psychosocial outcomes of stroke survivors. All outcomes will be analysed following the intention to treat principle. Generalised Estimation Equation models will be used to assess the intervention effect.Ethics and disseminationThis protocol was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No.: 2021.196-T). All participants will be required to provide written informed consent. Results of the study will be disseminated through publication in peer-reviewed journals and presentation at local or international conferences.Trial registration numberChiCTR2100050853.

Project description:IntroductionFalls and fall-related injuries are a serious cause of morbidity and cost to society. Environmental hazards are implicated as a major contributor to falls among older people. A recent Cochrane review found an environmental assessment, undertaken by an occupational therapist, to be an effective approach to reducing falls. However, none of the trials included a cost-effectiveness evaluation in the UK setting. This protocol describes a large multicentre trial investigating the clinical and cost-effectiveness of environmental assessment and modification within the home with the aim of preventing falls in older people.Methods and analysisA two-arm, modified cohort randomised controlled trial, conducted within England, with 1299 community-dwelling participants aged 65 years and above, who are at an increased risk of falls. Participants will be randomised 2:1 to receive either usual care or home assessment and modification. The primary outcome is rate of falls (falls/person/time) over 12 months assessed by monthly patient self-report falls calendars. Secondary self-reported outcome measures include: the proportion of single and multiple fallers, time to first fall over a 12-month period, quality of life (EuroQoL EQ-5D-5L) and health service utilisation at 4, 8 and 12 months. A nested qualitative study will examine the feasibility of providing the intervention and explore barriers, facilitators, workload implications and readiness to employ these interventions into routine practice. An economic evaluation will assess value for money in terms of cost per fall averted.Ethics and disseminationThis study protocol (including the original application and subsequent amendments) received a favourable ethical opinion from National Health Service West of Scotland REC 3. The trial results will be published in peer-reviewed journals and at conference presentations. A summary of the findings will be sent to participants.Trial registration numberISRCTN22202133; Pre-results.

Project description:BackgroundAdolescent girls are less physically active than recommended for health, and levels decline further as they approach adulthood. Peers can influence adolescent girls' physical activity. Interventions capitalising on peer support could positively impact physical activity behaviour in this group. Building on promising feasibility work, the purpose of this cluster randomised controlled trial is to assess whether the Peer-Led physical Activity iNtervention for Adolescent girls (PLAN-A) increases adolescent girls' physical activity and is cost effective.MethodsPLAN-A is a two-arm secondary school-based cluster randomised controlled trial, conducted with girls aged 13-14 years from twenty schools in the south west of England. The intervention requires participants to nominate influential girls within their year group to become peer supporters. The top 15% of girls nominated in each school receive three days of training designed to prepare them to support their peers to be more physically active during a ten-week intervention period. Data will be collected at two time points, at baseline (T0) and 5-6 months post-intervention (T1). Schools will be randomly allocated to the intervention (n = 10) or control (n = 10) arm after T0. At each time point, all consenting participants will wear an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity. Multivariable mixed effects linear regression will be used to estimate differences in the primary outcome between the two arms and will be examined on an Intention-to-Treat (ITT) basis. A self-report psychosocial questionnaire will be completed by participants to assess self-esteem and physical activity motivation. Resource use and quality of life will be measured for the purposes of an economic evaluation. A mixed-methods process evaluation will be conducted to explore intervention fidelity, acceptability and sustainability. Analysis of quantitative process evaluation data will be descriptive, and the framework method will be used to analyse qualitative data.DiscussionThis paper describes the protocol for the PLAN-A cluster randomised controlled trial, a novel approach to increasing adolescent girls' physical activity levels through peer support.Trial registrationISRCTN14539759-31 May, 2018.

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Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trial.

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Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trial.

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