Effect of Different Liners on Pulpal Outcome after Partial Caries Removal: A Preliminary 12 Months Randomised Controlled Trial

2019 ◽  
Vol 53 (5) ◽  
pp. 547-554 ◽  
Author(s):  
Shreya Singh ◽  
Shweta Mittal ◽  
Sanjay Tewari
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Permanent Teeth ◽  
Categorical Variables ◽  
Significant Difference ◽  
Caries Removal ◽  
Randomised Controlled ◽  
Analytical Approaches ◽  
Partial Caries Removal

Aim: The aim of this double-blinded parallel randomised controlled trial was to compare the effect of different liners on 12-month pulp health outcomes after partial caries removal (PCR) with composite restorations in permanent molars. Methods: The study was registered at clinicaltrials.gov with registration No. NCT0328695 and conducted in the Department of Conservative dentistry and Endodontics, Post Graduate Institute of Dental Sciences Rohtak with no external financial support. One hundred and ninety-eight participants (116 males, 82 females and age 14–54 years) with vital permanent mature mandibular molars having deep caries involving two-thirds or more of dentin were randomised to calcium hydroxide (CH), resin-modified GIC (RMGIC) and no liner (DC) groups after PCR. After a follow-up time of 12 months, success was defined as positive response to pulp sensibility and absence of periapical alterations. Results: Categorical variables were compared using chi-square test. Two analytical approaches were used, such as intention-to-treat and per-protocol approach. Success rates in per-protocol approach were 96.8, 96.5, and 94.6% for CH, RMGIC and DC groups, respectively with no significant difference between 3 groups (p = 0.811). None of the baseline variables had any significant influence on the treatment success. Conclusion: Partial caries excavation has a high success rate to treat deep carious lesions in permanent teeth after 12 months of follow-up, indicating that the retention of carious dentin does not interfere with pulp vitality or restoration survival. Also, the success of the treatment is independent of the lining material used over the demineralized dentin.

Capsular closure versus unrepaired interportal capsulotomy after hip arthroscopy in patients with femoroacetabular impingement, results of a patient-blinded randomised controlled trial

2021 ◽  
pp. 112070002110057
Author(s):  
Niels H Bech ◽  
Inger N Sierevelt ◽  
Sheryl de Waard ◽  
Boudijn S H Joling ◽  
Gino M M J Kerkhoffs ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Femoroacetabular Impingement ◽  
Hip Arthroscopy ◽  
Controlled Trial ◽  
Poor Quality ◽  
Control Group ◽  
Treatment Groups ◽  
Significant Difference ◽  
Randomised Controlled

Background: Hip capsular management after hip arthroscopy remains a topic of debate. Most available current literature is of poor quality and are retrospective or cohort studies. As of today, no clear consensus exists on capsular management after hip arthroscopy. Purpose: To evaluate the effect of routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy measured with NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS). Materials and methods: All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n = 116) were randomly assigned to one of both treatment groups and were operated by a single surgeon. Postoperative pain was measured with the NRS score weekly the first 12 weeks after surgery. The HAGOS questionnaire was measured at 12 and 52 weeks postoperatively. Results: Baseline characteristics and operation details were comparable between treatment groups. Regarding the NRS pain no significant difference was found between groups at any point the first 12 weeks after surgery ( p = 0.67). Both groups significantly improved after surgery ( p < 0.001). After 3 months follow-up there were no differences between groups for the HAGOS questionnaire except for the domain sport ( p = 0.02) in favour of the control group. After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p  > 0.05). Conclusions: The results of this randomised controlled trial show highest possible evidence that there is no reason for routinely capsular closure after interportal capsulotomy at the end of hip arthroscopy. Trial Registration: This trial was registered at the CCMO Dutch Trial Register: NL55669.048.15.

scholarly journals Evaluating the effectiveness of a group-based resilience intervention versus psychoeducation for emergency responders in England: A randomised controlled trial

PLoS ONE ◽  
2020 ◽  
Vol 15 (11) ◽  
pp. e0241704
Author(s):  
Jennifer Wild ◽  
Shama El-Salahi ◽  
Michelle Degli Esposti ◽  
Graham R. Thew
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Self Report ◽  
Post Traumatic Stress ◽  
Emergency Responders ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Resilience Intervention

Background Emergency responders are routinely exposed to traumatic critical incidents and other occupational stressors that place them at higher risk of mental ill health compared to the general population. There is some evidence to suggest that resilience training may improve emergency responders’ wellbeing and related health outcomes. The aim of this study was to evaluate the effectiveness of a tertiary service resilience intervention compared to psychoeducation for improving psychological outcomes among emergency workers. Methods We conducted a multicentre, parallel-group, randomised controlled trial. Minim software was used to randomly allocate police, ambulance, fire, and search and rescue services personnel, who were not suffering from depression or post-traumatic stress disorder, to Mind’s group intervention or to online psychoeducation on a 3:1 basis. The resilience intervention was group-based and included stress management and mindfulness tools for reducing stress. It was delivered by trained staff at nine centres across England in six sessions, one per week for six weeks. The comparison intervention was psychoeducation about stress and mental health delivered online, one module per week for six weeks. Primary outcomes were assessed by self-report and included wellbeing, resilience, self-efficacy, problem-solving, social capital, confidence in managing mental health, and number of days off work due to illness. Follow-up was conducted at three months. Blinding of participants, researchers and outcome assessment was not possible due to the type of interventions. Results A total of 430 participants (resilience intervention N = 317; psychoeducation N = 113) were randomised and included in intent-to-treat analyses. Linear Mixed-Effects Models did not show a significant difference between the interventions, at either the post-intervention or follow-up time points, on any outcome measure. Conclusions The limited success of this intervention is consistent with the wider literature. Future refinements to the intervention may benefit from targeting predictors of resilience and mental ill health. Trial registration ISRCTN registry, ISRCTN79407277.

scholarly journals Does addition of craving management tools in a stop smoking app improve quit rates among adult smokers? Results from BupaQuit pragmatic pilot randomised controlled trial.

2019 ◽  
Author(s):  
Aleksandra Herbec ◽  
Lion Shahab ◽  
Jamie Brown ◽  
Harveen Kaur Ubhi ◽  
Emma Beard ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Point Prevalence ◽  
Management Tools ◽  
Exact Test ◽  
Significant Difference ◽  
Continuous Abstinence ◽  
Randomised Controlled

Introduction: Delivery of craving management tools (CMTs) via smartphone applications (apps) may improve smoking cessation rates, but research on such programmes remainslimited, especially in real-world settings. This study evaluated the effectiveness of adding CMTs in a cessation app (BupaQuit).Methods: The study was a two-arm pragmatic pilot parallel randomised controlled trial, comparing a fully-automated BupaQuit app with CMT with a control app version withoutCMT. A total of 425 adult UK-based daily smokers were enrolled through open online recruitment (February 2015-March 2016), with no researcher involvement, and individually randomised within the app to the intervention (n=208) or control (n=217). The primary outcome was self-reported 14-day continuous abstinence assessed at 4-week follow-up. Secondary outcomes included 6-month point-prevalence and sustained abstinence, and app usage. The primary outcome was assessed with Fisher’s exact test using intent to treat with those lost to follow-up counted as smoking. Participants were not reimbursed.Results: Re-contact rates were 50.4% at 4 weeks and 40.2% at 6 months. There was no significant difference between intervention and control arms on the primary outcome (13.5% vs 15.7%; p=0.58;RR=0.86, 95% Confidence Interval (CI)=0.54-1.36) or secondary cessation outcomes (6-month point prevalence: 14.4% vs. 17.1%, p=0.51;RR=0.85, 95%CI=0.54-1.32; 6-month sustained: 11.1% vs 13.4%, p=0.55,RR=0.83,95%CI=0.50-1.38). Bayes factors supported the null hypothesis (B[0, 0,1.0986]=.20). Usage was similar across the conditions (mean/median logins: 9.6/4 vs. 10.5/5; time spent: 401.8/202s vs. 325.8/209s).Conclusions: The addition of craving management tools did not affect cessation, and the limited engagement with the app may have contributed to this.

scholarly journals Effect of a structured educational intervention on explanatory models of relatives of patients with schizophrenia

2006 ◽  
Vol 188 (3) ◽  
pp. 286-287 ◽  
Author(s):  
S. Das ◽  
B. Saravanan ◽  
K. P. Karunakaran ◽  
S. Manoranjitham ◽  
P. Ezhilarasu ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Educational Programme ◽  
Explanatory Models ◽  
Control Group ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Biomedical Treatment ◽  
Trial Participants

SummaryWe examined the effect of a structured educational programme on explanatory models of illness among the relatives of people with schizophrenia, in a randomised controlled trial. Participants were assessed at baseline (n=100) and after 2 weeks (n=75) using a vignette from the Short Explanatory Model Interview. There was a reduction in non-biomedical causal explanatory models at follow-up among those who had completed the structured educational programme compared with the control group. There was no significant difference in non-biomedical treatment explanatory models between the two groups.

scholarly journals Quarterly versus annual ECG screening for atrial fibrillation in older Chinese (AF-CATCH): a prospective, randomised, controlled trial

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
W Zhang ◽  
Y Chen ◽  
J.G Wang ◽  
Keyword(s):  
Atrial Fibrillation ◽  
Randomised Controlled Trial ◽  
Detection Rate ◽  
Controlled Trial ◽  
Hazard Ratio ◽  
Private Company ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Incident Cases

Abstract Background Screening for atrial fibrillation before symptoms manifested and subsequent initiation of oral anticoagulants (OACs), could prevent stroke and death. The most cost-effective strategy to screen atrial fibrillation in high-risk population aged 65 and over remains unknown. Methods We performed a randomised controlled trial that compares different screening frequencies of 30-second single-lead electrocardiography (ECG) in the detection of atrial fibrillation in Chinese residents (≥65 years old) in 5 community health centres in Shanghai. Participants without atrial fibrillation were randomised in a 1:1 ratio into annual (G1) and quarterly screening (G2) groups: the quarterly screening group was further randomised in a 3:1 ratio into subgroups of quarterly screening (G2–1) and quarterly screening PLUS (G2–2, ECG weekly for 1-month then quarterly). The primary outcome was the detection rate of atrial fibrillation. The intention-to-treat analysis was performed for all randomised patients who had at least one ECG recording during follow-up. Results Between April 17, 2017, and June 26, 2018, a total of 8240 participants were randomised into G1 (n=4120), G2–1 (n=3090) and G2–2 (n=1030), with a mean of 1.6, 3.5 and 5.2 ECG records respectively during a median of 2.1 years follow-up (13,284 person-years). 73 incident cases of atrial fibrillation occurred: 26 in G1 (4.1/1000 person-years) and 47 in G2 (6.7/1000 person-years; hazard ratio with G1, 1.71; 95% confidence interval [CI] 1.06–2.76; P=0.03). 40 incident cases were detected in G2–1 (7.2/1000 person-years; hazard ratio with G1, 1.83; 95% CI 1.12–3.00; P=0.02) and 7 in G2–2 (4.8/1000 person-years; hazard ratio with G1, 1.24; 95% CI 0.54–2.86; P=0.61). No significant difference was noted between G2–1 and G2–2 (hazard ratio with G2–1, 0.68; 95% CI 0.30–1.52; P=0.35). Conclusion Quarterly 30-second single-lead ECG screening significantly increased the detection rate of incident atrial fibrillation. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Bayer Healthcare Company

scholarly journals A randomised controlled trial to examine the effects of cinacalcet on bone, cardiovascular parameters and mortality in haemodialysis patients with secondary hyperparathyroidism

2020 ◽  
Author(s):  
Helen Eddington ◽  
Rajkumar Chinnadurai ◽  
Helen Alderson ◽  
Sara Ibrahim ◽  
Constantina Chrysochou ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Secondary Hyperparathyroidism ◽  
Standard Therapy ◽  
Augmentation Index ◽  
Controlled Trial ◽  
Left Ventricular ◽  
Agatston Score ◽  
Significant Difference ◽  
Randomised Controlled

Abstract Background Secondary hyperparathyroidism may lead to increased cardiovascular risk. The use of cinacalcet may improve bone and cardiovascular health with improved parathormone (PTH) and phosphate control. Methods This is an open-label prospective randomised controlled trial to compare progression of cardiovascular and chronic kidney disease mineral and bone disorder (CKD-MBD) parameters. Patients were randomised to receive cinacalcet alongside standard therapy or standard therapy alone. 36 haemodialysis patients who had >90 days on dialysis, iPTH >300pg/mL, calcium >2.1mmol/L and age 18-75 years were included. Following randomization, all 36 patients underwent an intensive 12-week period of bone disease management aiming for iPTH 150-300pg/mL. The primary outcome was change in vascular calcification using CT agatston score. Secondary outcomes included pulse wave velocity (PWV), left ventricular mass index (LVMI), carotid intima-media thickness (CIMT), augmentation index (Aix) and bone measurements. The above measurements were obtained at baseline and 12 months. The difference in mortality between the groups was compared during long-term follow-up. Results There was no evidence of a group difference in the progression of calcification (median change (IQR) cinacalcet: 488 (0 to1539); standard therapy: 563 (50 to 1214)). In a post hoc analysis combining groups there was a mean (SD) phosphate reduction of 0.3mmol/L (0.7) and median (IQR) iPTH reduction of 380pg/mL (-754, 120). Regression of LVMI and CIMT was seen (P=0.03 and P=0.001) and was significantly associated with change of phosphate on multi-factorial analyses. Over a median follow-up of 32 months, there was no significant difference in the mortality between the two groups.Conclusions No significant benefit in bone and cardiovascular markers was seen with the addition of cinacalcet to standard therapy over one year. Tight control of hyperphosphataemia and secondary hyperparathyroidism may lead to a reduction in LVMI and CIMT but this needs further investigation. Although the sample size was small, meticulous trial supervision resulted in very few protocol deviations with therapy.

scholarly journals Effectiveness of a volunteer befriending programme for patients with schizophrenia: randomised controlled trial

2019 ◽  
Vol 217 (3) ◽  
pp. 477-483 ◽  
Author(s):  
Stefan Priebe ◽  
Agnes Chevalier ◽  
Thomas Hamborg ◽  
Eoin Golden ◽  
Michael King ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Social Isolation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Social Contacts ◽  
Significant Difference ◽  
Randomised Controlled

BackgroundBefriending by volunteers has the potential to reduce the frequent social isolation of patients with schizophrenia and thus improve health outcomes. However, trial-based evidence for its effectiveness is limited.AimsTo conduct a randomised controlled trial of befriending for patients with schizophrenia or related disorders.MethodPatients were randomised to a befriending programme for 1 year or to receive information about social activities only (trial registration: ISRCTN14021839). Outcomes were assessed masked to allocation at the end of the programme; at 12 months and at a 6-month follow-up. The primary outcome was daily time spent in activities (using the Time Use Survey (TUS)) with intention-to-treat analysis.ResultsA total of 124 patients were randomised (63 intervention, 61 active control) and 92 (74%) were followed up at 1 year. In the intervention group, 49 (78%) met a volunteer at least once and 31 (49%) had more than 12 meetings. At 1 year, mean TUS scores were more than three times higher in both groups with no significant difference between them (adjusted difference 8.9, 95% CI −40.7 to 58.5, P = 0.72). There were no significant differences in quality of life, symptoms or self-esteem. However, patients in the intervention group had significantly more social contacts than those in the control group at the end of the 12-month period. This difference held true at the follow-up 6 months later.ConclusionsAlthough no difference was found on the primary outcome, the findings suggest that befriending may have a lasting effect on increasing social contacts. It may be used more widely to reduce the social isolation of patients with schizophrenia.

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