Selective outcome reporting in randomized clinical trials of dental implants

Author(s):  
D.I Sendyk ◽  
E.S Rovai ◽  
N.V Souza ◽  
M.C.Z Deboni ◽  
C.M Pannuti
Author(s):  
Daniel Isaac Sendyk ◽  
Nathalia Vilela Souza ◽  
João Batista César Neto ◽  
Dimitris N. Tatakis ◽  
Cláudio Mendes Pannuti

Materials ◽  
2021 ◽  
Vol 14 (12) ◽  
pp. 3234
Author(s):  
Georgina González-Valls ◽  
Elisabet Roca-Millan ◽  
Juan Manuel Céspedes-Sánchez ◽  
Beatriz González-Navarro ◽  
Aina Torrejon-Moya ◽  
...  

To determine the marginal bone loss and the survival, success and failure rates of narrow dental implants, a systematic literature search was carried out in the MEDLINE (Pubmed), Cochrane, Scopus, and Scielo databases for articles published between 2010 and 2021. The exclusion criteria were: systematic reviews, case reports, expert opinions; animal studies; samples of less than 10 subjects; follow-up periods of less than 36 months; smokers of minimum 10 cigarettes/day; and articles about mini-implants for orthodontic anchorage. Meta-analyses were performed to assess marginal bone loss and implant survival, success, and failure rates. Fifteen studies were included: 7 clinical trials, 3 randomized clinical trials, 3 cohort studies, and 2 case series. The total number of subjects was 773, in whom 1245 implants were placed. The survival rate for the narrow diameter implants was 97%, the success rate 96.8%, and the failure rate 3%. Marginal bone loss was 0.821 mm. All these data were evaluated at 36 months. Based on the literature, it can be considered that there is sufficient evidence to consider small diameter implants a predictable treatment option. These show favorable survival and success rates and marginal bone loss. All of them are comparable to those of standard diameter dental implants.


2020 ◽  
Author(s):  
Andrea Monsour ◽  
Emma J. Mew ◽  
Sagar Patel ◽  
Alyssandra Chee-a-tow ◽  
Leena Saeed ◽  
...  

Abstract Background: Evidence-based health care is informed by results of randomized clinical trials (RCTs) and their syntheses in meta-analyses. When the trial outcomes measured are not clearly described in trial publications, knowledge synthesis, translation, and decision-making may be impeded. While heterogeneity in outcomes measured in adolescent major depressive disorder (MDD) RCTs has been described, the comprehensiveness of outcome reporting is unknown. This study aimed to assess the reporting of primary outcomes in RCTs evaluating treatments for adolescent MDD. Methods: RCTs evaluating treatment interventions in adolescents with a diagnosis of MDD published between 2008 and 2017 specifying a single primary outcome were eligible for outcome reporting assessment. Outcome reporting assessment was done independently in duplicate using a comprehensive checklist of 58 reporting items. Primary outcome information provided in each RCT publication was scored as “fully reported”, “partially reported”, or “not reported” for each checklist item, as applicable. Results: Eighteen of 42 identified articles were found to have a discernable single primary outcome and were included for outcome reporting assessment. Most trials (72%) did not fully report on over half of the 58 checklist items. Items describing masking of outcome assessors, timing and frequency of outcome assessment, and outcome analyses were fully reported in over 70% of trials. Items less frequently reported included outcome measurement instrument properties (ranging from 6-17%), justification of timing and frequency of outcome assessment (6%), and justification of criteria used for clinically significant differences (17%). The overall comprehensiveness of reporting appeared stable over time. Conclusions: Heterogeneous reporting exists in published adolescent MDD RCTs, with frequent omissions of key details about their primary outcomes. These omissions may impair interpretability, replicability, and synthesis of RCTs that inform clinical guidelines and decision-making in this field. Consensus on the minimal criteria for outcome reporting in adolescent MDD RCTs is needed. Trial registration: Not applicable


2009 ◽  
Author(s):  
Martin Fenner

Last week the New England Journal of Medicine (NEJM) published a paper on selective outcome reporting in clinical trials (Vedula et al. 2009). The primary and secondary outcome(s) of a clinical trial could for example be survival in cancer patients or ...


2019 ◽  
Vol 13 (1) ◽  
pp. 470-477
Author(s):  
Vittorio Checchi ◽  
Fabrizio Racca ◽  
Davide Bencivenni ◽  
Laura Lo Bianco

Background: Correlation between high plaque index and inflammatory lesions around dental implants has been shown and this highlights the importance of patient plaque control. Until now, knowledge of peri-implant home care practices has been based on periodontal devices. Objective: The aim of this overview is to identify the presence of scientific evidence that peri-implant homecare plays a role in mucositis and peri-implantitis prevention. Methods: Different databases were used in order to detect publications reflecting the inclusion criteria. The search looked into peri-implant homecare studies published from 1991 to 2019 and the terms used for the identification of keywords were: Dental implants, Brush, Interproximal brushing, Interdental brushing, Power toothbrush, Cleaning, Interdental cleaning, Interspace cleaning, Flossing, Super floss, Mouth rinses, Chlorhexidine. The type of studies included in the selection for this structured review were Randomized Clinical Trials, Controlled Clinical Trials, Systematic Reviews, Reviews, Cohort Studies and Clinical cases. Results: Seven studies fulfilled all the inclusion criteria: 3 RCTs, one Consensus report, one cohort study, one systematic review and one review. Other 14 studies that partially met the inclusion criteria were analyzed and classified into 3 different levels of evidence: good evidence for RCTs, fair evidence for case control and cohort studies and poor evidence for expert opinion and case report. Conclusion: Not much research has been done regarding homecare implant maintenance. Scientific literature seems to show little evidence regarding these practices therefore most of the current knowledge comes from the periodontal literature. Manual and powered toothbrushes, dental floss and interdental brushes seem to be useful in maintaining peri-implant health. The use of antiseptic rinses or gels does not seem to have any beneficial effects. It can be concluded that to better understand which are the most effective home care practices to prevent mucositis and peri-implantitis in implant-rehabilitated patients, new specific high evidence studies are needed.


2021 ◽  
Author(s):  
Rokaia Ahmed Elagami ◽  
Tamara Kerber Tedesco ◽  
Claudio Mendes Pannuti ◽  
Gabriela Seabra da Silva ◽  
Mariana Minatel Braga ◽  
...  

Abstract BackgroundSelective outcome reporting (SOR) is a type of bias that occurs when the primary outcome of a randomized clinical trial (RCT) is omitted or changed prospectively. We evaluated the prevalence of SOR in RCTs on restorative caries treatment in primary teeth.MethodsWe conducted an electronic search on ClinicalTrials.gov and the World Health Organization (WHO) platform up to April/2021. We included RCT protocols that tested restorative treatments in primary teeth and excluded any protocol that has not resulted in at least one publication in a peer-reviewed scientific journal. The Chi-square test was used to detect the association between SOR and other variables (α = 5%).ResultsOut of 294 potential protocols, thirty were included. We found 34 corresponding publications and had the one that seemed to report the primary outcome and longest follow-up, resulting in 30 publications. SOR was observed in 53.3% (n=16) of the published trials and was significantly associated with the discrepancy in the follow-up period (p=0.017).ConclusionThere is a considerable prevalence of selective outcome reporting (SOR) on restorative trials in primary teeth. Properly pre-registered protocols and assessing them for the peer review processes will help decrease SOR.Practical implicationsRestorative treatment trials in primary teeth that selectively modify outcomes of interest have been shown to distort the treatment effect. Practitioners should avoid using restorative treatments based on misleading results in clinical practice.


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