Glossary for randomized clinical trials

Randomized clinical trials are positioned at the highest level of primary clinical evidence, as they are designed to be unbiased with a reduced risk of systematic error. The Consolidated Standards of Reporting Trials (CONSORT) statement was first developed in 1996 to improve the reporting quality of randomized clinical trials with updates being published subsequently. Recently, the Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) 2020 guidelines were developed exclusively for the field of Endodontics to address the suboptimal quality of randomized clinical trials submitted to Endodontic journals, which result in many being rejected. A principal flaw in submissions is the fact that many authors are unclear on the keys terms that should be used when developing manuscripts for publication. Clearly, authors should be aware of the most common terms used when conducting and reporting randomized clinical trials. Hence, the aim of the current paper is to present a comprehensive glossary of the terminology used in randomized clinical trials in order to assist authors when designing, executing and writing-up randomized clinical trials

Comparing the anaesthetic efficacy of 1.8 mL and 3.6 mL of anaesthetic solution for inferior alveolar nerve blocks for teeth with irreversible pulpitis: a systematic review and meta-analysis with trial sequential analysis

Background The scientific literature is contradictory in relation to selecting the appropriate volume of local anaesthetic solution for inferior alveolar nerve blocks (IANB) when attempting to anaesthetize mandibular teeth with irreversible pulpitis. Objectives To compare the efficacy of 1.8 and 3.6 mL of the same anaesthetic solution for IANBs when treating mandibular teeth with irreversible pulpitis. Methods A literature search was performed in PubMed, Scopus and EBSCOhost databases until May 2020. Randomized clinical trials published in English, comparing 1.8 with 3.6 mL of the same anaesthetic solution for IANBs in permanent mandibular teeth with irreversible pulpitis, were included. The risk of bias of the included trials was appraised using the revised Cochrane risk of bias tool. A meta-analysis was performed using the random-effects model. The effect of random errors on the results of the meta-analysis was evaluated by trial sequential analysis and the quality of evidence was appraised using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. Results Four clinical trials involving 280 teeth from patients with ages ranging from 18 to 65 years were included. Among the four trials, three were categorized as having a ‘low’ risk of bias and one was categorized as having ‘some concerns’. The primary meta-analysis revealed that 3.6 mL of anaesthetic solution when administered for IANBs was associated with significantly greater success rates compared with 1.8 mL (RR = 1.94; 95% CI, 1.07, 3.52; I2 = 77%). Similarly, the results of the sensitivity analysis (restricting trials only to those that used the Heft-Parker visual analogue pain scale) revealed that the use of 3.6 mL significantly increased the success of IANBs compared with 1.8 mL. The trial sequential analysis confirmed the evidence for the beneficial effect of 3.6 mL to achieve success for IANBs was ‘conclusive’. The quality of evidence was graded as ‘high’. Conclusion Increasing the volume of anaesthetic solution from 1.8 to 3.6 mL improved the success rate for IANBs in mandibular molars with irreversible pulpitis. The quality of the evidence was ‘high’. Future high-quality clinical trials are required with different types of anaesthetic solutions and other types of teeth

Association between diabetes and the outcome of root canal treatment in adults: An umbrella review

Background Diabetes mellitus is the most common metabolic disorder among dental patients. The association between diabetes and the outcome of root canal treatment is unclear. Aim To conduct an umbrella review to determine whether there is an association between diabetes and the outcome of root canal treatment. Data source. The protocol of the review was developed and registered in the PROSPERO database (ID number: 141684). Four electronic databases (PubMed, EBSCHOhost, Cochrane and Scopus databases) were used to perform a literature search until July 2019. Study eligibility criteria, participants, and interventions. Systematic reviews with or without meta‐analyses published in English assessing any outcomes of root canal treatment comparing diabetic and nondiabetic patients were included. Two reviewers were involved independently in study selection, data extraction and appraising the reviews that were included. Disagreements were resolved with the help of a third reviewer. Study appraisal and synthesis methods. The quality of the reviews was assessed using the AMSTAR tool (A measurement tool to assess systematic reviews), with 11 items. Each AMSTAR item was given a score of 1 if the criterion was met, or 0 if the criterion was not met or the information was unclear. Results Four systematic reviews were included. The AMSTAR score for the reviews ranged from 5‐7, out of a maximum score of 11 and all the systematic reviews were classified as “medium” quality. Limitations. Only two systematic reviews included a meta‐analysis. Only systematic reviews published in English were included. Conclusions and implications of key findings Diabetes mellitus is associated with the outcome of root canal treatment and can be considered as a preoperative prognostic factor

Preferred reporting items for animal studies in endodontology (PRIASE): a development protocol

The regulated use of animals in endodontic research is often necessary to investigate the biological mechanisms of endodontic diseases and to measure the preclinical efficacy, biocompatibility, toxicology and safety of new treatments, biomaterials, sealers, drugs, disinfectants, irrigants, devices and instruments. Animal testing is most crucial in situations when research on humans is not ethical, practical or has unknown health risks. Currently, there is a wide variability in the quality of manuscripts that report the results of animal studies. Towards the goal of improving the quality of publications, guidelines for preventing disability, pain, and suffering to animals, and enhanced reporting requirements for animal research have been developed. These guidelines are referred to as Animals in Research: Reporting In Vivo Experiments (ARRIVE). Henceforth, causing any form of animal suffering for research purposes is not acceptable and cannot be justified under any circumstances. The present report describes a protocol for the development of welfare and reporting guidelines for animal studies conducted in the specialty of Endodontology: the Preferred Reporting Items for Animal Studies in Endodontology (PRIASE) guidelines. The PRIASE guidelines will be developed by adapting and modifying the ARRIVE guidelines and the Clinical and Laboratory Images in Publication (CLIP) principles. The development of the new PRIASE guidelines will include a five‐step consensus process. An initial draft of the PRIASE guidelines will be developed by a steering committee. Each item in the draft guidelines will then be evaluated by members of a PRIASE Delphi Group (PDG) for its clarity using a dichotomous scale (yes or no) and suitability for its inclusion using a 9‐point Likert scale. The online surveys will continue until each item achieves this standard, and a set of items are agreed for further analysis by a PRIASE Face‐to‐face Consensus Meeting Group (PFCMG). Following the consensus meeting, the steering committee will finalize and confirm the PRIASE guidelines taking into account the responses and comments of the PFCMG. The PRIASE guidelines will be published and disseminated internationally and updated periodically based on feedback from stakeholders

Root canal irrigants influence the hydrophobicity and adherence of Staphylococcus epidermidis to root canal dentin: an in vitro study

published_or_final_versio

Glossary for systematic reviews and meta-analyses

A systematic review aims to answer a focussed research question through a structured review of the evidence, using a predefined methodology, which often includes a meta‐analysis. A meta‐analysis is a statistical method used to combine the effect estimates from the individual studies included in a systematic review. Systematic reviews and meta‐analyses are positioned at the highest level in the hierarchy of clinical evidence. The Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) statement was introduced in 2009 to help authors improve the quality and reliability of systematic reviews and meta‐analyses. Recently, the volume of systematic reviews and meta‐analyses in the field of Endodontology has increased; however, the quality of the published manuscripts has been reported to be sub‐optimal, which does not take account of the systematic reviews that were rejected because of more obvious deficiencies. The aim of this paper is to present a comprehensive glossary of terminology commonly used in systematic reviews and meta‐analyses in an attempt to provide easily understood definitions and explanations to assist authors when reporting systematic reviews and meta‐analyses and to allow those wishing to read them to become better informed

Guidelines for reporting the quality of clinical case reports in Endodontics: a development protocol.

Case reports are used to communicate interesting, new or rare condition/s, innovative treatment approaches or novel techniques. Apart from informing readers, such information has the potential to contribute towards further scientific studies and the development of newer management modalities. Reporting guidelines are used to inform authors of the quality standards required to ensure their case report is accurate, complete and transparent. The aim of this project is to develop and disseminate new guidelines - Preferred Reporting Items for Case reports in Endodontics (PRICE). The primary aim is to aid authors when constructing case reports in the field of Endodontics to ensure the highest possible reporting standards are adopted. The project leaders (PD and VN) formed a steering committee comprising of six additional members. Subsequently, a four-phase consensus process will be used: 1. Pre-online consensus activities (literature search, creating PRICE guidelines), 2. Online Consensus (Delphi Process), 3. Face-to-face consensus meeting, and 4. Post-meeting activities. The steering committee will develop the PRICE guidelines by identifying relevant items (quality standards) derived from the CAse REport guidelines and Clinical and Laboratory Images in Publications principles, focussing on the content of case reports. Following this, the steering committee will identify a PRICE Delphi Group (PDG) consisting of 30 members including academicians, practitioners, and members of the public. The individual items (components) of the PRICE checklist will be evaluated by the PDG based on a 9-point Likert scale. Only items scored between 7 and 9 by 70% or more members will be included in the draft checklist. The Delphi process will be continued until a consensus is reached and a final set of items agreed by the PDG members. Following this, a PRICE Face-to-Face meeting group (PFMG) will be formed with 20 members to achieve a final consensus. The final consensus-based checklist and flow diagram will be evaluated and approved by selected members of the PDG and PFMG. The approved PRICE checklist will be published in relevant journals, and disseminated via contacts in academic institutions and national endodontic societies, as well as being presented at scientific/clinical meetings. This article is protected by copyright. All rights reserved

PRISMA for abstracts: best practice for reporting abstracts of systematic reviews in Endodontology

An abstract is a brief overview of a scientific, clinical or review manuscript as well as a stand‐alone summary of a conference abstract. Scientists, clinician–scientists and clinicians rely on the summary information provided in the abstracts of systematic reviews to assist in subsequent clinical decision‐making. The Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) for Abstracts checklist was developed to improve the quality, accuracy and completeness of abstracts associated with systematic reviews and meta‐analyses. The PRISMA for Abstracts checklist provides a framework for authors to follow, which helps them provide in the abstract the key information from the systematic review that is required by stakeholders. The PRISMA for Abstracts checklist contains 12 items (title, objectives, eligibility criteria, information sources, risk of bias, included studies, synthesis of results, description of the effect, strength and limitations, interpretation, funding and systematic review registration) under six sections (title, background, methods, results, discussion, other). The current article highlights the relevance and importance of the items in the PRISMA for Abstracts checklist to the specialty of Endodontology, while offering explanations and specific examples to assist authors when writing abstracts for systematic reviews when reported in manuscripts or submitted to conferences. Strict adherence to the PRISMA for Abstracts checklist by authors, reviewers and journal editors will result in the consistent publication of high‐quality abstracts within Endodontology

Effectiveness of technology-enhanced learning in Endodontic education: a systematic review and meta-analysis

Sections ePDFPDF PDF Tools Share Abstract The aim of the present systematic review was to evaluate the effectiveness of technology‐enhanced learning (TEL) in the field of Endodontics to improve educational outcomes compared to traditional learning methods. Randomized controlled studies published in English were identified from two electronic databases (PubMed and Scopus) up to May 2018. Two authors independently performed study selection, data extraction and assessed the risk of bias (ROB). Any teaching method using TEL was considered as the intervention, and this was compared to traditional methods. The outcome measuring the effectiveness of learning activities was evaluated by Kirkpatrick's four‐level training evaluation model. The four levels of training outcomes are as follows: Reaction, Learning, Behaviour and Results. A meta‐analysis was performed to estimate the standardized mean difference (SMD) by the random effects model. In total, 13 studies were included in the systematic review. Only three studies were assessed as ‘low’ ROB. A meta‐analysis could not be performed in the domains of Reaction and Behaviour. No significant difference was observed in knowledge gain (Learning domain) between TEL and traditional methods (SMD, 0.14 (95% CI −0.10 to 0.39) I2 = 62.7%). Similarly, no difference was observed in performance (Behaviour domain). A variable response was found in attitude (Reaction domain). From the available evidence, it can be concluded that TEL is equally as effective as traditional learning methods