scholarly journals Effect of magnification on root coverage surgery

2020 ◽  
Vol 19 ◽  
pp. e201669
Author(s):  
Marcella Goetz Moro ◽  
Maria Luisa Silveira Souto ◽  
Emanuel Silva Rovai ◽  
João Batista Cesar Neto ◽  
Marinella Holzhausen ◽  
...  
Keyword(s):  
Randomized Trials ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Gingival Recession ◽  
Root Coverage ◽  
Randomized Controlled ◽  
Optical Magnification ◽  
Secondary Outcomes ◽  
Exposed Root

Root coverage surgery can be performed in patients with gingival recession to cover the exposed root aiming to control hypersensitivity and promotes better aesthetic. Optical magnification has been proposed as a refinement in this surgical technique to increase root coverage. This approach may lead to enhanced soft tissue stability, less post-operative discomfort, better predictability and esthetic appearance. Aim: This systematic review aimed to evaluate the effectiveness of magnification on root coverage surgery when compared to procedures performed without magnification. Methods: Randomized controlled trials with a follow-up of at least 6 months that compared surgeries for root coverage performed under optic magnification versus conventional (macro) root coverage surgery were screened. The primary outcome was mean root coverage (mm) (MRC) and secondary outcomes were percentage of root coverage (PRC) and complete root coverage (CRC). Results: Of 569 papers relevant to this review, seven were included. Meta-analysis showed that the use of magnification may favor greater PRC (7.38%, 95% CI 3.66-11.09). Conclusion: Magnification can increase PRC in root coverage surgeries. More randomized trials with the use of magnification may be necessary to verify if this benefit is clinically relevant, in order to justify the use of this device.

scholarly journals Conservative oxygen therapy for critically ill patients: a meta-analysis of randomized controlled trials

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Xiao-Li Chen ◽  
Bei-Lei Zhang ◽  
Chang Meng ◽  
Hui-Bin Huang ◽  
Bin Du
Keyword(s):  
Sensitivity Analysis ◽  
Randomized Controlled Trials ◽  
Critically Ill Patients ◽  
Oxygen Therapy ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Icu Patients ◽  
Randomized Controlled

Abstract Objective Conservative oxygen strategy is recommended in acute illness while its benefit in ICU patients remains controversial. Therefore, we sought to conduct a systematic review and meta-analysis to examine such oxygen strategies’ effect and safety in ICU patients. Methods We searched PubMed, Embase, and the Cochrane database from inception to Feb 15, 2021. Randomized controlled trials (RCTs) that compared a conservative oxygen strategy to a conventional strategy in critically ill patients were included. Results were expressed as mean difference (MD) and risk ratio (RR) with a 95% confidence interval (CI). The primary outcome was the longest follow-up mortality. Heterogeneity, sensitivity analysis, and publication bias were also investigated to test the robustness of the primary outcome. Results We included seven trials with a total of 5265 patients. In general, the conventional group had significantly higher SpO2 or PaO2 than that in the conservative group. No statistically significant differences were found in the longest follow-up mortality (RR, 1.03; 95% CI, 0.97–1.10; I2=18%; P=0.34) between the two oxygen strategies when pooling studies enrolling subjects with various degrees of hypoxemia. Further sensitivity analysis showed that ICU patients with mild-to-moderate hypoxemia (PaO2/FiO2 >100 mmHg) had significantly lower mortality (RR, 1.24; 95% CI, 1.05–1.46; I2=0%; P=0.01) when receiving conservative oxygen therapy. These findings were also confirmed in other study periods. Additional, secondary outcomes of the duration of mechanical ventilation, the length of stay in the ICU and hospital, change in sequential organ failure assessment score, and adverse events were comparable between the two strategies. Conclusions Our findings indicate that conservative oxygen therapy strategy did not improve the prognosis of the overall ICU patients. The subgroup of ICU patients with mild to moderate hypoxemia might obtain prognosis benefit from such a strategy without affecting other critical clinical results.

Acupuncture for tinnitus: a systematic review and meta-analysis of randomized controlled trials

2020 ◽  
pp. 096452842093838 ◽  
Author(s):  
Kaiyu Huang ◽  
Shuang Liang ◽  
Lei Chen ◽  
Antoine Grellet
Keyword(s):  
Randomized Controlled Trials ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Small Sample ◽  
Controlled Trials ◽  
Control Groups ◽  
Positive Effects ◽  
Randomized Controlled ◽  
Vas Score ◽  
Secondary Outcomes

Objective: To evaluate the efficacy/effectiveness of acupuncture for the treatment of tinnitus. Methods: Four English and four Chinese databases were searched for randomized controlled trials (RCTs) of acupuncture for tinnitus published before 30 September 2018. RCTs applying acupuncture alone compared with conventional treatments, sham acupuncture, or no treatment, as well as acupuncture plus conventional treatments compared with conventional treatments alone, were included. The primary outcome was the visual analogue scale (VAS). Secondary outcomes included tinnitus handicap inventory (THI) and tinnitus severity index (TSI) scores. Meta-analysis was conducted using RevMan V5.3 software. The protocol was registered in the PROSPERO database (ref. CRD42018108692). Results: Eight studies involving 504 participants were included. Meta-analysis showed no significant differences in the VAS score (mean difference (MD) = −1.81, 95% confidence interval (CI) = −3.69 to 0.07; p = 0.06) between the acupuncture and control groups. However, favorable effects of acupuncture on changes in THI score (MD = −10.11, 95% CI = −12.74 to −7.48; p < 0.001) and TSI score (MD = −8.36, 95% CI = −8.87 to −7.86; p < 0.001) were found. Conclusion: Acupuncture had no significant effect on the primary outcome of VAS score compared with control treatment; however, positive effects on secondary outcomes (THI and TSI score) were observed in acupuncture versus control groups. Due to the low quality and small sample size of the included trials, the level of evidence was insufficient to draw any definitive conclusions. Further rigorous and high-quality studies with larger sample sizes should be conducted to confirm the efficacy/effectiveness of acupuncture for tinnitus.

scholarly journals Effect of Vitamin D Supplementation on Pain: A Systematic Review and Meta-analysis

2016 ◽  
Vol 7;19 (7;9) ◽  
pp. 415-427
Author(s):  
Robert Scragg
Keyword(s):  
Vitamin D ◽  
Pain Score ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Vitamin D Supplementation ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
The Mean ◽  
Pain Improvement

Background: There is conflicting evidence from previous qualitative reviews on the effect of vitamin D supplementation on pain. Objective: To determine with quantitative methods if vitamin D supplementation lowers pain levels. Study Design: Quantitative meta-analysis of published randomized controlled trials (RCTs). Setting: This meta-analysis examined all studies involving the effect of vitamin D supplementation on pain score. Method: Electronic sources (Medline, Embase, Cochrane Central Register of Controlled Trials, clinical trials website, and Google scholar) were systematically searched for RCTs of vitamin D supplementation and pain from inception of each database to October 2015. Results: Nineteen RCTs with 3,436 participants (1,780 on vitamin D supplementation and 1,656 on placebo) were included in the meta-analysis. For the primary outcome (mean change in pain score from baseline to final follow-up), 8 trials with 1,222 participants on vitamin D and 1,235 on placebo reported a significantly greater mean decrease in pain score for the vitamin D group compared to placebo (mean difference -0.57, 95% CI: -1.00 to -0.15, P = 0.007). The effect from vitamin D was greater in patients recruited with pre-existing pain (P-value for interaction = 0.03). Fourteen studies (1,548 on vitamin D, 1,430 on placebo) reported the mean pain score at final follow-up outcome, and no statistical difference was observed (mean difference -0.06, 95%CI: -0.44 to 0.33, P = 0.78). In 4 studies which reported pain improvement (209 on vitamin D, 146 on placebo), the effect size although not significant, shows participants in the vitamin D supplementation group were more likely to report pain improvement compared with the placebo group (relative risk 1.38, 95%CI: 0.93 to 2.05, P = 0.11). Limitations: Only a few studies reported the mean score change from baseline to final follow-up, and we do not have enough data to determine any modifying effect of baseline vitamin D status and different doses of vitamin D supplementation on pain. Conclusion: A significantly greater mean decrease in pain score (primary outcome) was observed with vitamin D supplementation compared with placebo in people with chronic pain. These results suggest that vitamin D supplementation could have a role in the management of chronic pain. Key words: Meta-analysis, pain, randomized controlled trials, vitamin D supplementation

scholarly journals Free gingival grafting procedure after excisional biopsy, 12-year follow-up

2016 ◽  
Vol 10 (03) ◽  
pp. 432-434 ◽  
Author(s):  
Ilker Keskiner ◽  
B. Arzu Alkan ◽  
Zekeriya Tasdemir
Keyword(s):  
Excisional Biopsy ◽  
Gingival Recession ◽  
Dentin Hypersensitivity ◽  
Root Coverage ◽  
Free Gingival Graft ◽  
Gingival Enlargement ◽  
Gingival Graft ◽  
Grafting Procedure ◽  
Exposed Root

ABSTRACTThe total removal of a lesion via excisional biopsy causes gingival recession, resulting in dentin hypersensitivity and esthetical problems. In this case report, a gingival recession defect resulting from an excisional biopsy was treated with a free gingival grafting procedure performed during the same appointment, and its 12-year follow-up was presented. A 44-year-old female patient was presented to our clinic with a firm, pedunculated, red gingival enlargement located on the labial surface of lower incisors. The exposed root surface, after the excisional biopsy, was covered with a free gingival graft. The lesion was pathologically diagnosed as pyogenic granuloma, and in the early postoperative phase, no recurrence was observed, but partial root coverage was determined. At 6-month follow-up, root coverage resulting from “creeping attachment” was observed, and this situation was maintained throughout the 12-year follow-up period. Repetitious postoperative discomfort and emotional stress for the patient may be avoided with a timesaving single appointment performing excisional biopsy and free gingival graft. Free gingival grafting procedure was used for this purpose not only to cover exposed root surfaces but also to eliminate dentin hypersensitivity and make oral hygiene procedures more effective.

Verbal Contingencies in the Lidcombe Program: A Noninferiority Trial

2020 ◽  
Vol 63 (10) ◽  
pp. 3419-3431
Author(s):  
Michelle Donaghy ◽  
Sue O'Brian ◽  
Mark Onslow ◽  
Robyn Lowe ◽  
Mark Jones ◽  
...  
Keyword(s):  
Treatment Effect ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Clinical Applications ◽  
Verbal Response ◽  
Randomized Controlled ◽  
Open Plan ◽  
Secondary Outcomes ◽  
Present Trial

Purpose The Lidcombe Program is an efficacious and effective intervention for early stuttering. The treatment is based on parent verbal response contingent stimulation procedures, which are assumed to be responsible for treatment effect. The present trial tested this assumption. Method The design was a parallel, open plan, noninferiority randomized controlled trial. In the experimental arm, the five Lidcombe Program verbal contingencies were removed from parent instruction. The primary outcome was beyond-clinic percentage syllables stuttered at 18-month follow-up. Seventy-four children and their parents were randomized to one of the two treatment arms. Results Findings of noninferiority were inconclusive for the primary outcome of stuttering severity, based on a margin of 1.0 percentage syllables stuttered. Conclusions The inconclusive finding of noninferiority means it is possible that verbal contingencies make some contribution to the Lidcombe Program treatment effect. However, considering all primary and secondary outcomes, an overriding impression from the trial is a similarity of outcomes between the control and experimental arms. The clinical applications of the trial are discussed, along with further research that is needed.

Cartilage Restoration of the Knee

2015 ◽  
Vol 44 (7) ◽  
pp. 1888-1895 ◽  
Author(s):  
Raman Mundi ◽  
Asheesh Bedi ◽  
Linda Chow ◽  
Sarah Crouch ◽  
Nicole Simunovic ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Randomized Trials ◽  
Meta Analysis ◽  
Pooled Analysis ◽  
Cartilage Defects ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Standardized Mean Difference

Background: Focal cartilage defects of the knee are a substantial cause of pain and disability in active patients. There has been an emergence of randomized controlled trials evaluating surgical techniques to manage such injuries, including marrow stimulation (MS), autologous chondrocyte implantation (ACI), and osteochondral autograft transfer (OAT). Purpose: A meta-analysis was conducted to determine if any single technique provides superior clinical results at intermediate follow-up. Study Design: Systematic review and meta-analysis of randomized controlled trials. Methods: The MEDLINE, EMBASE, and Cochrane Library databases were systematically searched and supplemented with manual searches of PubMed and reference lists. Eligible studies consisted exclusively of randomized controlled trials comparing MS, ACI, or OAT techniques in patients with focal cartilage defects of the knee. The primary outcome of interest was function (Lysholm score, International Knee Documentation Committee score, Knee Osteoarthritis Outcome Score) and pain at 24 months postoperatively. A meta-analysis using standardized mean differences was performed to provide a pooled estimate of effect comparing treatments. Results: A total of 12 eligible randomized trials with a cumulative sample size of 765 patients (62% males) and a mean (±SD) lesion size of 3.9 ± 1.3 cm2 were included in this review. There were 5 trials comparing ACI with MS, 3 comparing ACI with OAT, and 3 evaluating different generations of ACI. In a pooled analysis comparing ACI with MS, there was no difference in outcomes at 24-month follow-up for function (standardized mean difference, 0.47 [95% CI, –0.19 to 1.13]; P = .16) or pain (standardized mean difference, –0.13 [95% CI, –0.39 to 0.13]; P = .33). The comparisons of ACI to OAT or between different generations of ACI were not amenable to pooled analysis. Overall, 5 of the 6 trials concluded that there was no significant difference in functional outcomes between ACI and OAT or between generations of ACI. Conclusion: There is no significant difference between MS, ACI, and OAT in improving function and pain at intermediate-term follow-up. Further randomized trials with long-term outcomes are warranted.

scholarly journals Efficacy and safety of IL-6 inhibitors in patients with COVID-19 pneumonia: a systematic review and meta-analysis of multicentre, randomized trials

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Alessandro Belletti ◽  
Corrado Campochiaro ◽  
Marilena Marmiere ◽  
Valery Likhvantsev ◽  
Andrey Yavorovskiy ◽  
...  
Keyword(s):  
Adverse Events ◽  
Randomized Trials ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Group Versus ◽  
Control Group ◽  
Open Label ◽  
Secondary Infections ◽  
All Cause Mortality

Abstract Purpose COVID-19 is characterized by dysregulated immune response, respiratory failure and a relevant mortality rate among hospitalized patients. Interleukin-6 (IL-6) is involved in COVID-19-associated cytokine storm, and several trials investigated whether its inhibition could improve patients’ outcome. We performed a meta-analysis of randomized trials (RCT) to test this hypothesis. Materials and methods Two independent investigators searched PubMed, Scopus, ClnicalTrials.gov and medRxiv up to September 1st, 2021. Inclusion criteria were: administration of tocilizumab or sarilumab; COVID-19 adult patients with pneumonia; and being a RCT. Primary outcome was mortality at the longest follow-up. Secondary outcomes included intubation rate and incidence of adverse events. Two independent investigators extracted data from eligible trials. Results Of the 763 studies assessed, 15 RCTs were included (9,320 patients), all were multicentre, and the majority open-label vs standard treatment. IL-6 inhibitors were associated with reduced all-cause mortality at the longest follow-up (1315/5,380 [24.4%] in the IL-6 inhibitors group versus 1080/3,814 [28.3%] in the control group, RR = 0.90; 95% CI 0.84 to 0.96; p for effect = 0.003, I2 = 0%, with 13 studies included), with reduction in 28/30-day mortality and intubation rates, and with no increase in adverse events and secondary infections. Conclusion IL-6 inhibitors reduced longest follow-up mortality and intubation in COVID-19 patients. Findings need to be confirmed in high-quality RCTs.

Oral factor Xa inhibitors and risk of subdural hematoma

Neurology ◽  
2020 ◽  
Vol 95 (5) ◽  
pp. e480-e487
Author(s):  
Luciana Catanese ◽  
John W. Eikelboom ◽  
Jackie Bosch ◽  
Olga Shestakovska ◽  
Kelvin Ng ◽  
...  
Keyword(s):  
Randomized Trials ◽  
Meta Analysis ◽  
Anticoagulation Therapy ◽  
Factor Xa ◽  
Factor Xa Inhibitors ◽  
Randomized Controlled ◽  
Important Complication ◽  
Increased Risk ◽  
The Mean

ObjectiveSubdural hematomas (SDHs) are an uncommon, but important, complication of anticoagulation therapy. We hypothesized that the risks of SDH would be similar during treatment with oral factor Xa inhibitors compared with aspirin.MethodsWe assessed the frequency and the effects of antithrombotic treatments on SDHs in the recent international Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) randomized trial comparing aspirin 100 mg daily, rivaroxaban 5 mg twice daily, and rivaroxaban 2.5 mg twice daily plus aspirin. A systematic review/meta-analysis of randomized trials comparing oral factor Xa inhibitors vs aspirin on SDH risk was undertaken.ResultsAmong 27,395 COMPASS participants, 28 patients with SDHs were identified (mean age 72 years). SDH-associated mortality was 7%. Incidence was 0.06 per 100 patient-years (11 SDH/17,492 years observation) during the mean 23-month follow-up among aspirin-assigned patients and did not differ significantly between treatments. Three additional randomized controlled trials including 16,177 participants reported a total of 14 SDHs with an incidence ranging from 0.06 to 0.1 per 100 patient-years. Factor Xa inhibitor use was not associated with an increased risk of SDH compared to aspirin (odds ratio, 0.97; 95% confidence interval, 0.52–1.81; I2 = 0%).ConclusionThe frequency of SDH was similar in all 3 treatment arms of the COMPASS trial. The COMPASS trial results markedly increase the available evidence from randomized comparisons of oral factor Xa inhibitors with aspirin regarding SDH. From available, albeit limited, evidence from 4 randomized trials, therapeutic dosages of factor Xa inhibitors do not appear to increase the risk of SDH compared with aspirin.Clinical trial identifier number:NCT01776424.

Comparison of Percentage of Syllables Stuttered With Parent-Reported Severity Ratings as a Primary Outcome Measure in Clinical Trials of Early Stuttering Treatment

2018 ◽  
Vol 61 (4) ◽  
pp. 811-819 ◽  
Author(s):  
Mark Onslow ◽  
Mark Jones ◽  
Sue O'Brian ◽  
Ann Packman ◽  
Ross Menzies ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Trials ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Analysis Of Covariance ◽  
Data Sets ◽  
Randomized Controlled ◽  
Absolute Agreement

Purpose This report investigates whether parent-reported stuttering severity ratings (SRs) provide similar estimates of effect size as percentage of syllables stuttered (%SS) for randomized trials of early stuttering treatment with preschool children. Method Data sets from 3 randomized controlled trials of an early stuttering intervention were selected for analyses. Analyses included median changes and 95% confidence intervals per treatment group, Bland–Altman plots, analysis of covariance, and Spearman rho correlations. Results Both SRs and %SS showed large effect sizes from pretreatment to follow-up, although correlations between the 2 measures were moderate at best. Absolute agreement between the 2 measures improved as percentage reduction of stuttering frequency and severity increased, probably due to innate measurement limitations for participants with low baseline severity. Analysis of covariance for the 3 trials showed consistent results. Conclusion There is no statistical reason to favor %SS over parent-reported stuttering SRs as primary outcomes for clinical trials of early stuttering treatment. However, there are logistical reasons to favor parent-reported stuttering SRs. We conclude that parent-reported rating of the child's typical stuttering severity for the week or month prior to each assessment is a justifiable alternative to %SS as a primary outcome measure in clinical trials of early stuttering treatment.

scholarly journals Randomized controlled trial of the “WISER” intervention to reduce healthcare worker burnout

2021 ◽  
Author(s):  
Jochen Profit ◽  
Kathryn C. Adair ◽  
Xin Cui ◽  
Briana Mitchell ◽  
Debra Brandon ◽  
...  
Keyword(s):  
Healthcare Worker ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Well Being ◽  
Work Life ◽  
Web Based ◽  
Randomized Controlled ◽  
Intervention Efficacy ◽  
Secondary Outcomes

Abstract Objective Test web-based implementation for the science of enhancing resilience (WISER) intervention efficacy in reducing healthcare worker (HCW) burnout. Design RCT using two cohorts of HCWs of four NICUs each, to improve HCW well-being (primary outcome: burnout). Cohort 1 received WISER while Cohort 2 acted as a waitlist control. Results Cohorts were similar, mostly female (83%) and nurses (62%). In Cohorts 1 and 2 respectively, 182 and 299 initiated WISER, 100 and 176 completed 1-month follow-up, and 78 and 146 completed 6-month follow-up. Relative to control, WISER decreased burnout (−5.27 (95% CI: −10.44, −0.10), p = 0.046). Combined adjusted cohort results at 1-month showed that the percentage of HCWs reporting concerning outcomes was significantly decreased for burnout (−6.3% (95%CI: −11.6%, −1.0%); p = 0.008), and secondary outcomes depression (−5.2% (95%CI: −10.8, −0.4); p = 0.022) and work-life integration (−11.8% (95%CI: −17.9, −6.1); p < 0.001). Improvements endured at 6 months. Conclusion WISER appears to durably improve HCW well-being. Clinical Trials Number NCT02603133; https://clinicaltrials.gov/ct2/show/NCT02603133

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