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BACKGROUND: Recently, trials have supported changes in deep caries management. However, reporting might lack details, affecting interpretation and implementation. Thus, we aimed to evaluate the adherence to the CONSORT statement and the risk of bias of randomized controlled trials (RCTs) on deep caries management published in pediatric dental journals. METHODS: We searched PubMed for RCTs in six pediatric dental journals between 2010 and 2022, focusing on deep caries lesion management. Adherence to the CONSORT guideline and the risk of bias were assessed using a modified tool with 19 items; each scored from 0 to 2 (maximum of 38 points), and the Cochrane risk-of-bias (RoB 2) tool. We performed descriptive and regression analyses (α = 5%). RESULTS: We analyzed 127 RCTs. The mean (standard deviation) CONSORT adherence score was 21.1 (6.7). Notably, 96.1% of the studies received a score of 2 for the "intervention" item, whereas 83.5% scored 0 for the "estimated effect size". The risk of bias assessment revealed that 40.2% of the RCTs were at high risk, 59% were at low risk, and 0.8% were at low risk. RCTs with a high risk of bias had lower CONSORT scores (p<0.001) than those with low or some concerns. RCTs published in journals without the endorsement of the CONSORT statement had lower scores than those in journals with the endorsement of the CONSORT statement. Older RCTs (6-10 years old and more than 10 years old) showed significantly lower CONSORT statement compliance than trials published recently within 5 years. CONCLUSION: Adherence to the CONSORT was relatively low among the investigated RCTs. Moreover, lower adherence to the CONSORT was associated with a higher risk of bias. TRIAL REGISTRATION: This study protocol was prospectively registered on the Open Science Framework - DOI ( 10.17605/OSF.IO/V6SYZ ).
Subject(s)
Bias , Dental Caries , Guideline Adherence , Randomized Controlled Trials as Topic , Dental Caries/therapy , Humans , Randomized Controlled Trials as Topic/standardsABSTRACT
INTRODUCTION: Paediatric dentistry should rely on evidence-based clinical decisions supported by high-quality, unbiased systematic reviews (SRs). Therefore, the purpose of this study was to systematically evaluate the methodological quality and risk of bias of SRs focused on non- and micro-invasive treatment for caries lesions in primary and permanent teeth. METHODS: A comprehensive search was conducted in multiple databases, including MEDLINE/PubMed, Scopus, Web of Science, EMBASE, Epistemonikos, and ProQuest, up to March 2023 to identify relevant systematic reviews (SRs) focused on non- and micro-invasive caries treatment. Two independent reviewers extracted data from the included SRs and assessed the methodological quality and risk of bias using the AMSTAR 2 and ROBIS tools, respectively. RESULTS: A total of 39 SRs were included in the analysis. Among these, 27 SRs (69.2%) were assessed as having critically low methodological quality, 11 SRs (28.2%) were considered to have low methodological quality and only one SR was rated as high-quality. The primary concern identified was the absence of protocol registration before the commencing the study, observed in 33 SR when using the AMSTAR 2 tool. According to the ROBIS tool, 21 studies (53.8%) were categorised as low risk of bias, 10 (25.6%) as high risk and eight (20.5%) as unclear risk of bias. CONCLUSION: Our analysis revealed that SRs focused on non- and micro-invasive treatment for caries in children and adolescents had critically low methodological quality according to the AMSTAR 2 tool but demonstrated a low risk of bias based on the ROBIS tool. These findings highlight the importance of emphasizing prospective protocol registration, clear reporting of statistical analyses, and addressing potential bias implications within this topic. By addressing these issues, we can enhance the quality of SRs and ensure that clinical decisions rely on unbiased and trustworthy evidence. Registry DOI: 10.17605/OSF.IO/AR4MS.
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OBJECTIVE: To analyze bibliometrics, characteristics, and the risk of bias of randomized controlled trials (RCTs) on dental implants published in six high-impact factor journals and to identify factors contributing to citation number. MATERIALS AND METHODS: A systematic electronic search was conducted in four databases (PubMed, Scopus, Web of Science, and Cochrane Central Register of Controlled Trials) to identify RCTs on dental implants published in six dental journals between 2016 and 2017. Twenty-five bibliometric variables and paper characteristics were extracted to evaluate their contribution to the citation count. Risk of bias analysis was performed using the RoB2 tool. Negative binomial regression was used to examine the effects of predictor variables on the Citation count. Significance level was set to 5%. RESULTS: A total of 150 RCTs included received a cumulative citation count of 3452 until July 2022. In the negative binomial regression analysis, open-access RCTs exhibited 60% more citations, and RCTs that presented statistical significance received 46% more citations. Conversely, first author affiliations from Africa, Asia and Oceania continents showed 49% fewer citations than publications from Europe. Regarding the risk of bias, 73.3% of the RCTs had some concerns, while 26% were deemed to have a high risk of bias. Only one RCT (0.07%) showed a low risk of bias. CONCLUSION: Within the limitation of the study, factors such as open access, statistically significant results, and country influence the number of citations received by the RCTs on dental implants.
Subject(s)
Bibliometrics , Dental Implants , Randomized Controlled Trials as Topic , HumansABSTRACT
BACKGROUND: Clinical practice guidelines (CPGs) enhance health care and aid clinicians' decisions. AIM: To evaluate the quality of clinical guidelines in paediatric dentistry using the AGREE II tool. DESIGN: PubMed, EMBASE, Scopus, LIVIVO, Lilacs, international guidelines websites, scientific societies, and gray literature were searched until September 2021. We included paediatric dental clinical guidelines and excluded drafts or guidelines for patients with special needs. Two independent reviewers performed quality assessment using the APPRAISAL OF GUIDELINES FOR RESEARCH & EVALUATION II (AGREE II) instrument. We calculated the mean overall domain scores (95% confidence interval) for each guideline. We used regression analysis to correlate the score of overall assessment and the six domains of AGREE II with guideline characteristics. RESULTS: Forty-four guidelines were included in this study. Highest mean score was for Domain 4 (Clarity of Presentation; 58%, 95% CI: 50.8-64.9), whereas the lowest was for Domain 5 (Applicability; 16%, 95% CI: 10.8-21.4). The reporting quality was improved in Domains 1-5 with reporting checklists (p < .001), whereas that of Domain 6 was improved by decreasing years since publication (p = .047). CONCLUSION: Paediatric dental guidelines do not comply with the methodological quality standard, especially in Domain 5 (Applicability). The AGREE reporting checklist should be implemented with a system to evaluate the certainty of evidence for future guidelines.
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BACKGROUND: Selective outcome reporting (SOR) is a bias that occurs when the primary outcome of a randomised clinical trial (RCT) is omitted or changed. AIM: To evaluate the prevalence of SOR in RCTs on restorative treatment in primary teeth. DESIGN: We conducted an electronic search on ClinicalTrials.gov and the World Health Organization platform (International Clinical Trials Registry Platform) on 1st of April 2021, with no registry time or language restrictions. We included RCT protocols that evaluated restorative treatments in primary teeth and excluded trials that did not have a complete publication in a scientific journal. The chi-squared test was used to identify the association between SOR and variables as a discrepancy in the follow-up period, the timing of registration, the type of sponsorship and the type of study design (α = 5%). RESULTS: Of the 294 identified protocols, 30 were included in the study. 83.3% of trials were registered retrospectively. SOR was observed in 53.3% (n = 16) of the published trials and was significantly associated with a discrepancy in the follow-up period (p = .017). CONCLUSIONS: The high prevalence of SOR in RCTs on restorative treatment proves that this is a prominent threat. A proper preregistered protocol, declaration of any protocol deviation and allowance of stakeholders to compare the protocol with that of the submitted papers will achieve transparency.
