The OHStat Guidelines for Reporting Observational Studies and Clinical Trials in Oral Health Research: explanation and elaboration.

Adequate and transparent reporting is necessary for critically appraising research. Yet, evidence suggests that the design, conduct, analysis, interpretation, and reporting of oral health research could be greatly improved. Accordingly, the Task Force on Design and Analysis in Oral Health Research-statisticians and trialists from academia and industry-empaneled a group of authors to develop methodological and statistical reporting guidelines identifying the minimum information needed to document and evaluate observational studies and clinical trials in oral health: the OHstat Guidelines. Drafts were circulated to the editors of 85 oral health journals and to Task Force members and sponsors and discussed at a December 2020 workshop attended by 49 researchers. The final version was subsequently approved by the Task Force in September 2021, submitted for journal review in 2022, and revised in 2023. The checklist consists of 48 guidelines: 5 for introductory information, 17 for methods, 13 for statistical analysis, 6 for results, and 7 for interpretation; 7 are specific to clinical trials. Each of these guidelines identifies relevant information, explains its importance, and often describes best practices. The checklist was published in multiple journals. The article was published simultaneously in JDR Clinical and Translational Research, the Journal of the American Dental Association, and the Journal of Oral and Maxillofacial Surgery. Completed checklists should accompany manuscripts submitted for publication to these and other oral health journals to help authors, journal editors, and reviewers verify that the manuscript provides the information necessary to adequately document and evaluate the research.

Data sharing and transparency indicators in published RCTs in Oral Health between 2017 and 2023.

OBJECTIVES: To record the proportion of data sharing reporting in terms of primary data and/or statistical code of Randomized Controlled Trials (RCTs), published across 12 high impact journals in Dentistry, covering 6 specialty domains. Associations with certain journal, publication and outcome characteristics were examined. Transparency indicators such as registration or funding statements were assessed. METHODS: We identified and included all RCTs published from January 1st, 2017 to December 31st, 2023 in journals of high impact of the following domains: Periodontology, Endodontics, Restorative Dentistry/Prosthodontics, Orthodontics, Pediatric Dentistry, Oral/Maxillofacial Surgery. The primary outcome was the proportion of RCTs reporting their intent to share or openly shared primary data and we tested for associations with potential predictors. Funding, registration, and statistical code/script sharing practices were also examined. RESULTS: A total of 752 RCTs were included, of which only 119 (15.8%) either openly provided their data or included a statement of intention to share upon request. Only one study openly provided the statistical code underlying the analysis used. RCTs in periodontology more frequently included statements about positive intent to share (57/210;27.1%), followed by Orthodontics (35/157;22.3%). Significant effects of year, dentistry domain and continent of authorship on data sharing practices were identified (p < 0.001 in all cases). There was evidence that registered RCTs had 2.04 times higher odds for intention to share data (95%confidence interval: 1.06, 3.92;p = 0.03). CONCLUSIONS: Overall, in oral health RCTs, empirical evidence suggested very low prevalence of positive data sharing practices. Enhancing transparency is pivotal in promoting reproducibility and credibility of research findings. CLINICAL SIGNIFICANCE: The findings of this empirical report bring attention to key transparency indicators in randomized controlled trials. These largely impact on the credibility and reproducibility of the evidence base for clinical decision making.

Clinical trial registration in oral health journals.

Prospective registration of randomized controlled trials (RCTs) represents the best solution to reporting bias. The extent to which oral health journals have endorsed and complied with RCT registration is unknown. We identified journals publishing RCTs in dentistry, oral surgery, and medicine in the Journal Citation Reports. We classified journals into 3 groups: journals requiring or recommending trial registration, journals referring indirectly to registration, and journals providing no reference to registration. For the 5 journals with the highest 2012 impact factors in each group, we assessed whether RCTs with results published in 2013 had been registered. Of 78 journals examined, 32 (41%) required or recommended trial registration, 19 (24%) referred indirectly to registration, and 27 (35%) provided no reference to registration. We identified 317 RCTs with results published in the 15 selected journals in 2013. Overall, 73 (23%) were registered in a trial registry. Among those, 91% were registered retrospectively and 32% did not report trial registration in the published article. The proportion of trials registered was not significantly associated with editorial policies: 29% with results in journals that required or recommended registration, 15% in those that referred indirectly to registration, and 21% in those providing no reference to registration (P = 0.05). Less than one-quarter of RCTs with results published in a sample of oral health journals were registered with a public registry. Improvements are needed with respect to how journals inform and require their authors to register their trials.

Actualización de las pautas para la publicación en RAOA de acuerdo con las normativas internacionales / An update on the guidelines for RAOA according to current international publishing regulations

A fin de mejorar su calidad informativa, la Revista de la Asociación Odontológica Argentina se ajusta a la normativa internacional para la presentación de publicaciones periódicas

El por qué de la ética en la investigación científica / The reason for an ethic requirement in scientific research

Las normas internacionales que rigen actualmente los proyectos de investigación odontológica en seres humanos (aún respecto del uso de piezas dentarias extraídas) o de experimentación en animales, exigen que se cumplan los requisitos establecidos para cada caso por la legislación vigente en el país donde se realiza el proyecto, y que cuenten también con la revisión y la aprobación de un comité institucional de ética para la investigación científica certificado, requisito indispensable para la publicación de los resultados de una investigación de esas características. En ese sentido, y a partir del presente número, la Revista de la Asociación Odontológica Argentina ha modificado las normas para la publicación de trabajos de investigación, considerando como condición excluyente la revisión y la aprobación previa del proyecto de parte de un Comité de Etica reconocido, a fin de proteger y asegurar los derechos fundamentales y el bienestar de los pacientes que participen en investigaciones clínicas, el de los animales empleados con fines experimentales y garantizar el respeto de los principios y compromisos bioéticos asumidos por la comunidad científica.

Use of standards in papers published in dental journals

This study evaluated the use de standards in papers published in Brazilian and international dental journals. Papers published from January 2006 to December 2010 in the following journals were examined: Brazilian Dental Journal (BDJ), Brazilian Oral Research (BOR), Journal of Applied Oral Sciences (JAOS), Journal of Dental Research (JDR) and Dental Materials (DM). In addition to the title and type of study, issue, volume and year of publication, the following information was recorded from each paper: identification of any standard reported in the study; in case of no reported standard, indication if a standard could be used in the study. A total of 3,046 papers were examined, being 937 from DM, 936 from JDR, 489 from JAOS, 348 from BDJ, and 336 from BOR. Considering the papers that could use some standard, DM showed the highest percentage (24.9%) of reporting standards/paper, followed by JAOS (10.3%), BOR (10.1%), BDJ (6.3%) and JDR (2.4%), meaning for example that, from 936 papers examined from the JDR, 623 could use some standard but only 15 papers reported them. From all papers examined, 309 (10.1%) reported using some standard. The ISO standards were mostly reported (57.8%), followed by ASTM standards (23.7%) and 74 (18.5%) standards from other international organizations (e.g. ADA and CIE). Despite of the high impact factors of the selected dental journals, their published papers could use standards more often. This study should assist journal editors to encourage authors to consult and refer to available standards to support the scientific papers.

Este estudo avaliou o uso de normas científicas em artigos de Odontologia publicados em periódicos brasileiros e internacionais. Trabalhos publicados de janeiro de 2006 a dezembro de 2010 foram examinados nas seguintes revistas: Brazilian Dental Journal (BDJ), Brazilian Oral Research (BOR); Journal of Applied Oral Science (JAOS), Journal of Dental Research (JDR) e Dental Materials (DM). Além do título, tipo de estudo, volume e ano de publicação, as seguintes informações foram registradas a partir de cada artigo: identificação de normas relatadas no estudo; em caso negativo, relatar se alguma norma poderia ser aplicada no estudo. Um total de 3.046 artigos foi examinado como segue: 937 no DM, 936 no JDR, 489 no JAOS, 348 BDJ e 336 no BOR. Considerando os artigos que poderiam usar alguma norma, o DM apresentou o maior percentual (24,9%) de normas/artigos relatados, seguido pelo JAOS (10,3%), BOR (10,1%), BDJ (6,3%) e JDR (2,4%), o que significa que de 936 trabalhos analisados do JDR, 623 poderiam ter usado alguma norma, mas apenas 15 relataram o uso. De todos os trabalhos examinados, 309 (10,1%) estudos relataram alguma norma. As normas ISO foram relatadas na maior parte (57,8%), seguido pelas normas ASTM (23,7%) e 74 (18,5%) feitas por outras organizações internacionais (por exemplo, ADA e CIE). Apesar do alto fator de impacto dos periódicos selecionados, seus artigos publicados poderiam utilizar as normas com maior frequência. Este estudo deve alertar os editores de periódicos a incentivar os autores a consultar as normas disponíveis para apoiar a metodologia dos trabalhos científicos.

Clinical research in implant dentistry: study design, reporting and outcome measurements: consensus report of Working Group 2 of the VIII European Workshop on Periodontology.

AIMS: The objective of this working group was to assess and make specific recommendations to improve the quality of reporting of clinical research in implant dentistry and discuss ways to reach a consensus on choice of outcomes. MATERIAL AND METHODS: Discussions were informed by three systematic reviews on quality of reporting of observational studies (case series, case-control and cohort) and experimental research (randomized clinical trials). An additional systematic review provided information on choice of outcomes and analytical methods. In addition, an open survey among all workshop participants was utilized to capture a consensus view on the limits of currently used survival and success-based outcomes as well as to identify domains that need to be captured by future outcome systems. RESULTS: The Workshop attempted to clarify the characteristics and the value in dental implant research of different study designs. In most areas, measurable quality improvements over time were identified. The Workshop recognized important aspects that require continued attention by clinical researchers, funding agencies and peer reviewers to decrease potential bias. With regard to choice of outcomes, the limitations of currently used systems were recognized. Three broad outcome domains that need to be captured by future research were identified: (i) patient reported outcome measures, (ii) peri-implant tissue health and (iii) performance of implant supported restorations. Peri-implant tissue health can be measured by marginal bone level changes and soft tissue inflammation and can be incorporated in time to event analyses. CONCLUSIONS: The Workshop recommended that collaboration between clinicians and epidemiologists/clinical trials specialists should be encouraged. Aspects of design aimed at limitation of potential bias should receive attention by clinical researchers, funding agencies and journal editors. Adherence to appropriate reporting guidelines such as STROBE and CONSORT are necessary standards. Research on outcome measure domains is an area of top priority and should urgently inform a proper process leading to a consensus on outcome measures in dental implant research.

Statistical errors in microleakage studies in operative dentistry. A survey of the literature 2001-2009.

The aim of this study was to assess the literature on microleakage of direct restorations in operative dentistry indexed in the ISI Web of Science, in order to assess the robustness of the statistical methodology used. Our database included 226 scientific papers (published between 2001 and 2009 in 22 journals) from the journal citation report categories 'Dentistry, Oral Surgery and Medicine' and 'Materials Science, Biomaterials'. We reviewed all articles to find potential mistakes that are commonly made at different stages in the scientific research process. Microleakage was assessed quantitatively in 50 (22.2%) studies and qualitatively in 176 (77.8%) studies. In all studies reviewed the statistical methods used were appropriate for the category attributed to the outcome variable, but in 13% of the total, the chi-square test or parametric methods were inappropriately used afterwards. When the appropriate statistical methods were applied in studies that had originally employed inappropriate methods to analyse their data, and in which the authors provided raw data, an alteration of the conclusions was necessary in 15.4% of these re-analysed studies. This survey also showed that the statistical methodology applied varies considerably for similar experimental designs. This could have an effect on statistical results; hence, a more standardized methodology should be implemented.

An AMSTAR assessment of the methodological quality of systematic reviews of oral healthcare interventions published in the Journal of Applied Oral Science (JAOS)

BACKGROUND: Systematic reviews are not an assembly of anecdotes but a distillation of current best available evidence on a particular topic and as such have an important role to play in evidence-based healthcare. A substantial proportion of these systematic reviews focus on interventions, and are able to provide clinicians with the opportunity to understand and translate the best available evidence on the effects of these healthcare interventions into clinical practice. The importance of systematic reviews in summarising and identifying the gaps in evidence which might inform new research initiatives is also widely acknowledged. Their potential impact on practice and research makes their methodological quality especially important as it may directly infuence their utility for clinicians, patients and policy makers. The objectives of this study were to identify systematic reviews of oral healthcare interventions published in the Journal of Applied Oral Science (JAOS) and to evaluate their methodological quality using the evaluation tool, AMSTAR. METHODS: Potentially eligible systematic reviews in JAOS were identifed through an electronic search of the Scientific Electronic Library Online (SciELO). Details of the relevant aspects of methodology as reported in these systematic reviews were extracted from the full text publications. Methodological quality was assessed independently by two reviewers using the AMSTAR questionnaire. RESULTS: Five systematic reviews were identifed, one of which was subsequently excluded as it was a review of a diagnostic test. Summary AMSTAR scores for the four included reviews were: 1, 5, 2 and 4 out of a maximum score of 11 (range 1-5, mean 3) with only one of the reviews scoring 5. CONCLUSION: AMSTAR evaluation of the methodological quality of the relatively small number of systematic reviews published in JAOS illustrated that there was room for improvement. Pre-publication and editorial appraisal of future systematic reviews might beneft from the application of tools such as AMSTAR and is to be recommended.

Ethical issues in instructions to authors of journals in oral-craniomaxillofacial/facial plastic surgery and related specialties.

BACKGROUND: Ethical standards of biomedical publications are associated with editorial leadership, such as contents of instructions to authors and journal's mechanisms for research and publication ethics. OBJECTIVES: To compare ethical issues in the guidelines for authors in oral-craniomaxillofacial/facial plastic surgery (OCM-FPS) journals with those in plastic surgery and otorhinolaryngology/head and neck surgery (ORL-HNS) journals, and to evaluate the relationship between journal's impact factor (IF) and ethical issues in the instructions to authors. METHODS: This study used a cross-sectional study design. The predictor variables were journal's specialty and IF. The outcome variable was the presence of seven ethical issues in the online versions of journal's instructions to authors in October 2009. We included only journals with identifiable IF for 2008, published in English, French, German and Thai. Appropriate descriptive and univariate statistics were computed for all study variables. The level of statistical significance was set at P<0.05. RESULTS: The sample was composed of 48 journals: seven OCM-FPS (14.6%), 14 plastic surgery (29.2%) and 27 ORL-HNS (56.2%) journals. Only four journals (8.3%) mentioned all ethical issues in their guidelines for authors. Neither journal's specialty nor IF was linked to completeness of the ethical requirements. CONCLUSIONS: The results of this study suggest that ethical issues in the instructions to authors of most IF-indexed journals in OCM-FPS, plastic surgery and ORL-HNS are incomplete, regardless of specialty and IF. There is room for substantial improvement to uphold scientific integrity of these surgical specialties.

Orthognathic treatment and temporomandibular disorders: a systematic review. Part 1. A new quality-assessment technique and analysis of study characteristics and classifications.

INTRODUCTION: Orthognathic treatment is undertaken to correct jaw discrepancies and involves a combination of orthodontics and surgery. The effects of orthodontic treatment on temporomandibular disorders (TMD) have been widely debated in the literature, but fewer studies focus on the effects of orthognathic treatment on TMD. METHODS: A systematic review was conducted to (1) determine the percentage of orthognathic patients with signs or symptoms of TMD, (2) establish the range of signs or symptoms, and (3) examine studies that followed patients longitudinally through treatment to determine the effect of orthognathic intervention on TMD symptoms. RESULTS: Of 480 identified articles, 53 were eligible for inclusion in this review. Part 1 of this 2-part article describes the methodology of conducting this review, the difficulties encountered (including the quality-assessment issues), and a narrative analysis of study characteristics and classification methods. Part 2 reports the remaining results, evidence tables, and meta-analyses. CONCLUSIONS: The diversity of diagnostic criteria and classification methods used in the included studies makes interstudy comparisons difficult. There is a definitive need for well-designed studies with standardized diagnostic criteria and classification methods for TMD.

Termination of pregnancy after prenatal diagnosis of cleft lip and palate--possible influence on reports of prevalence.

Elective termination of pregnancy is prohibited in many countries, even after prenatal diagnosis of oral clefts. Though some studies address registries on termination of pregnancy, many investigations include only livebirths. This may lead to underestimation of the overall occurrence of oral clefts, influencing their reported prevalence. This paper does not intend to discuss if termination of pregnancy because of the presence of an oral cleft is justifiable from ethical, moral, or religious standpoints. Rather, its main goal is to promote a reflection on how the prevalence of oral clefts has been addressed and to rethink the reported differences in prevalence. Authors publishing on the prevalence of oral clefts might indicate the regulations and practices on pregnancy termination in their countries, so that readers may have an idea of what is beyond those findings.