How different attributes are weighted in professionals' decision-making in Pediatric Dentistry-a protocol for guiding discrete choice experiment focused on shortening the evidence-based practice implementation for dental care.

BACKGROUND: Important evidence has been constantly produced and needs to be converted into practice. Professional consumption of such evidence may be a barrier to its implementation. Then, effective implementation of evidence-based interventions in clinical practice leans on the understanding of how professionals value attributes when choosing between options for dental care, permitting to guide this implementation process by maximizing strengthens and minimizing barriers related to that. METHODS: This is part of a broader project investigating the potential of incorporating scientific evidence into clinical practice and public policy recommendations and guidelines, identifying strengths and barriers in such an implementation process. The present research protocol comprises a Discrete Choice Experiment (DCE) from the Brazilian oral health professionals' perspective, aiming to assess how different factors are associated with professional decision-making in dental care, including the role of scientific evidence. Different choice sets will be developed, either focusing on understanding the role of scientific evidence in the professional decision-making process or on understanding specific attributes associated with different interventions recently tested in randomized clinical trials and available as newly produced scientific evidence to be used in clinical practice. DISCUSSION: Translating research into practice usually requires time and effort. Shortening this process may be useful for faster incorporation into clinical practice and beneficial to the population. Understanding the context and professionals' decision-making preferences is crucial to designing more effective implementation and/or educational initiatives. Ultimately, we expect to design an efficient implementation strategy that overcomes threats and potential opportunities identified during the DCEs, creating a customized structure for dental professionals. TRIAL REGISTRATION: https://osf.io/bhncv .

Validation of the internal structure of the Brazilian Dental Vulnerability Scale.

OBJECTIVE: This study aimed to evaluate evidence of validity of internal structure of the Brazilian Dental Vulnerability Scale (EVO-BR) when applied in Brazil. METHODS: This is a psychometric study that seeks to validate a scale elaborated by evidence of internal structure. Data collection was conducted in 18 basic health units that implement the Brazilian Healthcare Planning (PAS) methodology, across the five regions of Brazil. The initial version of the EVO-BR contained 41 items that measured dental vulnerability and was applied to users of the Brazilian Unified Health System (SUS) aged 18 years or older who were in basic health units for consultation with higher education professionals. To evaluate the evidence, the following statistical analyses were performed: exploratory factor analysis, confirmatory factor analysis, and network analysis. RESULTS: A total of 1,753 users participated in the study. To adjust the sample, we considered the factorability obtained from Kaiser-Meyer-Olkin (KMO) test = 0.65, Bartlett sphericity test = 8019.7, and a matrix determinant of 0.008. The initial parallel analysis indicated a four-dimensional model and had the items adjusted according to factor loading (ranging from 0.38 to 0.99), common factors (0.13 to 0.89), and Pratt's measure, until the model presented congruence in the statistical and interpretative principles simultaneously. The final model contained 15 items, maintaining the four dimensions indicated by the parallel analysis, and held an explained variance of 68.56%. CONCLUSIONS: The EVO-BR is a validated scale to measure dental vulnerability and, thus, can contribute to the organization of access to the oral health team in primary health care (PHC) by stratifying the population, as recommended in the Brazilian Healthcare Planning.

Risk of bias and methodological critical appraisal in systematic reviews of non- and micro-invasive caries management for primary and permanent teeth.

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.

Prevalence of Bruxism in Children and Adolescents with Cerebral Palsy: Systematic Review and Meta-analysis.

AIMS: To perform a systematic review and meta-analysis compiling data on the prevalence of bruxism in children and adolescents with cerebral palsy. METHODS AND RESULTS: Searches were carried out in PubMed/Medline, Web of Science, and Scopus databases to identify the articles published by February 2023. Two independent reviewers, and in duplicate, employed a two-stage process to select publications. The same two reviewers performed the data extraction. Studies were included when the following eligibility criteria were met: performed in children and/or adolescents with cerebral palsy and reporting bruxism. Potentially eligible studies were read in full and excluded that: not presented numerical data on the prevalence of bruxism; not reported how the bruxism was assessed; not reported data about the cerebral palsy; and not an observational study. The risk assessment of bias was assessed by the Newcastle- Ottawa Scale. After reading the titles and abstracts of the 358 identified articles, eight articles from 1966 to 2020 were included. The main reason for not including the studies was not to report data about bruxism (59.3%), and 44.5% were excluded for not reporting data from patients with cerebral palsy. The studies were carried out in schools, university hospitals, or centers for patients with special needs (Brazil, the United States, and Egypt). The pooled prevalence of bruxism in children and adolescents with cerebral palsy was 46% (95%CI: 0.38-0.55) after removing one study. CONCLUSION: The pooled prevalence of bruxism in children with cerebral palsy can be considered high since almost half of the studied population is affected by this condition. PROSPERO #CRD42021225781.

Do the clinical practice guidelines for paediatric dentistry meet the quality standards? A meta-research and quality appraisal using the AGREE II tool.

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.

Survival rate of the Hall technique compared with resin composite restoration in multi-surface cavities in primary teeth: a 1-year randomized clinical trial.

BACKGROUND: Hall technique (HT) has been indicated for teeth with dentinal caries lesion; however, extensive cavities, with more than two surfaces still seem challenging for restorative treatment in pediatric dentistry, resulting in a higher failure rate and an increased need for retreatment. OBJECTIVES: To compare the survival rate of the Hall technique preformed metal crown (HT) with resin composite restoration (RC) for multi-surface cavitated caries lesions in primary molars. METHODOLOGY: In this multicenter two-arm randomized clinical trial, children between 4 and 9 years of age with at least one primary molar with cavitated caries lesion involving more than two surfaces, including one buccal or palatal/lingual surface, were selected from 17 Brazilian cities. A total of 364 teeth were allocated into two groups: (1) teeth treated with selective caries removal and RC and (2) treated with the HT. The survival rate was assessed at 6 and 12 months after the interventions. Survival analysis was performed with the Kaplan‒Meier method. Cox regression was used to determine the influence of explanatory variables on the survival rate (α=5%). RESULTS: After 12 months, 292 teeth were re-evaluated. A total of 358 teeth were re-evaluated at least once during the study and included in the survival analysis. The HT (87.8%) resulted in a higher survival rate than RC restoration (75.7%) (p=0.004). CONCLUSION: HT has a higher survival rate than RC as a treatment for multi-surface cavitated caries lesions in primary teeth. ClinicalTrials.gov: NCT02782390.

Deep Carious Lesions Management with Stepwise, Selective, or Non-Selective Removal in Permanent Dentition: A Systematic Review of Randomized Clinical Trials.

OBJECTIVE: The goal of this systematic study was to investigate the effectiveness of selective, stepwise, and non-selective removal techniques for caries removal in permanent teeth with deep carious lesions. The primary focus was the results found comparing techniques for caries removal to check whether there was pulp exposition; the secondary was the materials used for pulp protection and clinical findings reported within the included studies. METHODS: The search was performed in two databases (PubMed/MEDLINE and Web Of Science). The studies included in this systematic review were selected based on eligibility criteria. The inclusion criteria were: (1) randomized controlled trials (RCTs), (2) that compared the total removal of carious tissue with selective removal in permanent teeth with deep carious lesions, (3) with a follow-up period of at least 6 months, and (4) publications in English. Regarding the exclusion criteria, the following were not considered: (1) articles published in other languages, (2) articles that did not compare the different types of total/selective decay removal, and (3) articles published before January 2008. The risk of bias and the quality of the included studies were independently assessed by two reviewers using the RoB 2 tool. RESULTS: 5 out of 105 potentially eligible studies were included. Regarding the teeth included in the study, three articles performed management only on permanent molars, while other studies also performed management on incisors/canines/premolars/molars. Management protocols were divided into nonselective caries removal and partial caries removal (selective/stepwise). The theory of non-selective caries removal was considered an excessive, unnecessarily invasive option and a form of outdated management, and selective removal was preferred. CONCLUSION: The selective removal technique presented a higher success rate and fewer incidences of pulpal exposure than total removal, after up to 18 months of follow up. Moreover, only one session seemed to be a better management choice compared to two sessions because the cavity re-opening procedure is more prone to pulp exposure and highly depends on patient commitment. Otherwise, at 5 years of follow up, there was no difference between selective removal and total removal in management longevity. In addition, there were also no differences between the success of the materials used for definitive restorations in teeth subjected to any of the techniques evaluated.

Methodological quality of network meta-analysis in dentistry: a meta-research.

This meta-research aimed to provide an overview of the methodological quality and risk of bias of network meta-analyses (NMA) in dentistry. Searches for NMA of randomized clinical trials with clinical outcomes in dentistry were performed in databases up to January 2022. Two reviewers independently screened titles/abstracts, selected full texts, and extracted the data. The adherence to PRISMA-NMA reporting guideline, the AMSTAR-2 methodological quality tool, and the ROBIS risk of bias tool were assessed in the studies. Correlation between the PRISMA-NMA adherence and the AMSTAR-2 and ROBIS results was also investigated. Sixty-two NMA studies were included and presented varied methodological quality. According to AMSTAR-2, half of the NMA presented moderate quality (n = 32; 51.6%). The adherence to PRISMA-NMA also varied. Only 36 studies (58.1%) prospectively registered the protocol. Other issues lacking of reporting were data related were data related to the NMA geometry and the assessment of results consistency, and the evaluation of risk of bias across the studies. ROBIS assessment showed a high risk of bias mainly for domains 1 (study eligibility criteria) and 2 (identification and selection of studies). Correlation coefficients between the PRISMA-NMA adherence and the AMSTAR-2 and ROBIS results showed moderate correlation (rho < 0.6). Overall, NMA studies in dentistry were of moderate quality and at high risk of bias in several domains, especially study selection. Future reviews should be better planned and conducted and have higher compliance with reporting and quality assessment tools.

Is there an acceptable surrogate for caries clinical trials? Evidence from a systematic review of primary studies.

BACKGROUND: There is currently a lack of evidence supporting the use of valid surrogates in caries clinical trials. This study aimed at examining the validity of two surrogate outcomes used in randomized clinical trials for caries prevention, pit and fissure sealants and fluoridated dentifrices, according to the Prentice criteria. METHODS: A systematic review was conducted in MEDLINE (PubMed), LILACS and Scopus databases up to 05 October 2022. The grey literature and the list of eligible studies' references were also screened. The search was conducted, selecting randomized clinical trials focussed on dental caries prevention using pit and fissure sealants or fluoridated dentifrices and with at least one surrogate endpoint for cavitated caries lesions. The risk of each surrogate endpoint and for the occurrence of cavitated caries lesions was calculated and compared. The association between each surrogate and the presence of cavitation was quantified, and each outcome was assessed graphically for validity according to the Prentice criteria. RESULTS: For pit and fissure sealants, from 1696 potentially eligible studies, 51 were included; while for fluoridated dentifrices, of 3887 potentially eligible studies, four were included. Possible surrogates assessed were retention of sealants, presence of white spot lesions, presence of plaque or marginal discoloration around the sealants, oral hygiene index, radiographic and fluorescence caries lesion assessments. However, only the retention of sealants and the presence of white spot lesions could be evaluated for their validity according to the Prentice criteria. CONCLUSION: Loss of retention of sealants and the presence of white spot lesions do not fulfil all of the Prentice criteria. Therefore, they cannot be considered valid surrogates for caries prevention.

Effect of botulinum toxin A on pain, bite force, and satisfaction of patients with bruxism: A randomized single-blind clinical trial comparing two protocols.

Purpose: The current study aims to evaluate bite force, perception of orofacial pain, and treatment satisfaction of patients with bruxism using two protocols of botulinum toxin A (BTX-A) injections. Material and Methods: Two groups of patients seeking bruxism treatment and presenting bilateral orofacial pain of muscle origin were randomly created according to BTX-A injection sites: masseter muscle only, bilaterally (3 points in each muscle, 10 U per point), and masseter and temporal muscles (3 points in each masseter muscle and 2 points in each temporal muscle, 10 U per point). The patients were evaluated preoperatively and longitudinally at 15, 90, 120, and 180 days by the use of visual analog scales for pain and treatment satisfaction and a gnathodynamometer for bite force recording. Results: The final sample included 10 participants in each group. Both groups presented mitigation of pain at 15, 90, 120, and 180 days in comparison with baseline; however, reduction in the posterior bite force was noted only at 15, 90, and 120 days. Quite high treatment satisfaction was reported from both groups at 15, 90, 120, and 180 days. No differences were observed between the groups in all evaluations and study periods. Conclusion: In general, considering pain relief, reduction in bite force, and treatment satisfaction, both protocols of BTX-A seem to be somewhat equally effective in the short-term management (up to 120 days) of bruxism.

Associated factors and treatment options for sleep bruxism in children: an umbrella review.

Data on clinical management options for sleep bruxism in the primary dentition are inconclusive. This umbrella review aimed to synthesize the available evidence from systematic reviews (SRs) on the associated factors and treatment approaches for clinical management of sleep bruxism in children. A search was conducted in the MEDLINE/PubMed, Web of Science, Embase, and OpenGrey databases up to March 2022. SRs published on sleep bruxism in children containing data on associated factors or treatment outcomes were included. The AMSTAR-2 tool was used to assess the methodological quality of SRs. The search identified 444 articles, of which six were included. Sleep conditions, respiratory changes, personality traits, and psychosocial factors were the associated factors commonly identified. Treatments included psychological and pharmacological therapies, occlusal devices, physical therapy, and surgical therapy. All SRs included presented a high risk of bias. Overlapping of the included studies was considered very high. The best evidence available to date for the management of sleep bruxism in children is based on associated factors, with sleep duration and conditions, respiratory changes, as well as personality traits and psychosocial factors being the most important factors commonly reported by studies. However, there is currently insufficient evidence to make recommendations for specific treatment options.

Selective outcome reporting in paediatric dentistry restorative treatment randomised clinical trials-A meta-research.

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.

Methodological quality of network meta-analysis in dentistry: a meta-research

Abstract This meta-research aimed to provide an overview of the methodological quality and risk of bias of network meta-analyses (NMA) in dentistry. Searches for NMA of randomized clinical trials with clinical outcomes in dentistry were performed in databases up to January 2022. Two reviewers independently screened titles/abstracts, selected full texts, and extracted the data. The adherence to PRISMA-NMA reporting guideline, the AMSTAR-2 methodological quality tool, and the ROBIS risk of bias tool were assessed in the studies. Correlation between the PRISMA-NMA adherence and the AMSTAR-2 and ROBIS results was also investigated. Sixty-two NMA studies were included and presented varied methodological quality. According to AMSTAR-2, half of the NMA presented moderate quality (n = 32; 51.6%). The adherence to PRISMA-NMA also varied. Only 36 studies (58.1%) prospectively registered the protocol. Other issues lacking of reporting were data related were data related to the NMA geometry and the assessment of results consistency, and the evaluation of risk of bias across the studies. ROBIS assessment showed a high risk of bias mainly for domains 1 (study eligibility criteria) and 2 (identification and selection of studies). Correlation coefficients between the PRISMA-NMA adherence and the AMSTAR-2 and ROBIS results showed moderate correlation (rho < 0.6). Overall, NMA studies in dentistry were of moderate quality and at high risk of bias in several domains, especially study selection. Future reviews should be better planned and conducted and have higher compliance with reporting and quality assessment tools.

Survival rate of the Hall technique compared with resin composite restoration in multi-surface cavities in primary teeth: a 1-year randomized clinical trial

Abstract Background Hall technique (HT) has been indicated for teeth with dentinal caries lesion; however, extensive cavities, with more than two surfaces still seem challenging for restorative treatment in pediatric dentistry, resulting in a higher failure rate and an increased need for retreatment. Objectives To compare the survival rate of the Hall technique preformed metal crown (HT) with resin composite restoration (RC) for multi-surface cavitated caries lesions in primary molars. Methodology In this multicenter two-arm randomized clinical trial, children between 4 and 9 years of age with at least one primary molar with cavitated caries lesion involving more than two surfaces, including one buccal or palatal/lingual surface, were selected from 17 Brazilian cities. A total of 364 teeth were allocated into two groups: (1) teeth treated with selective caries removal and RC and (2) treated with the HT. The survival rate was assessed at 6 and 12 months after the interventions. Survival analysis was performed with the Kaplan‒Meier method. Cox regression was used to determine the influence of explanatory variables on the survival rate (α=5%). Results After 12 months, 292 teeth were re-evaluated. A total of 358 teeth were re-evaluated at least once during the study and included in the survival analysis. The HT (87.8%) resulted in a higher survival rate than RC restoration (75.7%) (p=0.004). Conclusion HT has a higher survival rate than RC as a treatment for multi-surface cavitated caries lesions in primary teeth. ClinicalTrials.gov: NCT02782390

Associated factors and treatment options for sleep bruxism in children: an umbrella review

Abstract Data on clinical management options for sleep bruxism in the primary dentition are inconclusive. This umbrella review aimed to synthesize the available evidence from systematic reviews (SRs) on the associated factors and treatment approaches for clinical management of sleep bruxism in children. A search was conducted in the MEDLINE/PubMed, Web of Science, Embase, and OpenGrey databases up to March 2022. SRs published on sleep bruxism in children containing data on associated factors or treatment outcomes were included. The AMSTAR-2 tool was used to assess the methodological quality of SRs. The search identified 444 articles, of which six were included. Sleep conditions, respiratory changes, personality traits, and psychosocial factors were the associated factors commonly identified. Treatments included psychological and pharmacological therapies, occlusal devices, physical therapy, and surgical therapy. All SRs included presented a high risk of bias. Overlapping of the included studies was considered very high. The best evidence available to date for the management of sleep bruxism in children is based on associated factors, with sleep duration and conditions, respiratory changes, as well as personality traits and psychosocial factors being the most important factors commonly reported by studies. However, there is currently insufficient evidence to make recommendations for specific treatment options.

Pulp vitality of primary molars with deep caries treated with ART restorations: 2-year RCT.

The aim of this study was to compare the pulp vitality of primary teeth with deep caries treated with two restorative techniques. The restoration survival rate was also evaluated as a secondary outcome. Children aged from 4 to 8 years with at least one deep carious lesion in molars were selected at the Ibirapuera University dental clinic. One hundred and eight deciduous molars were allocated into two groups: (1) restoration with calcium hydroxide cement lining followed by filling with high-viscosity glass ionomer cement (CHC+HVGIC) or (2) restoration with HVGIC. Pulp vitality and restoration survival were evaluated at 6, 12, and 24 months. Intent-to-treat analysis was used for pulp vitality, and survival analysis was performed with the Kaplan-Meier method (α=5%). Results: At 24 months, 86 restorations were evaluated, and 91 were evaluated at least once during the study. There was no significant difference between the restorative treatments regarding pulp vitality (CHC +HVGIC=70% and HVGIC=68.5%) (OR=1.091; CI95%=0.481-2.475). However, HVGIC (73%) restorations showed a higher survival rate than CHC+HVGIC (50%) (p=0.021). Thus, it can conclude that deep caries in primary molars should be restored with HVGIC, since the technique results in similar pulp vitality to the CHC +HVGIC, but with a higher restoration survival rate.

Psychological Impact of the COVID-19 Pandemic on Dentists in Latin America's Epicenter: São Paulo, Brazil.

The present study aimed to assess the prevalence and associated factors of stress and anxiety symptoms among dentists during the COVID-19 pandemic in the state of São Paulo, Brazil. A structured questionnaire was sent electronically to 93,280 dentists with active registration in the Dental Council of São Paulo, Brazil, enquiring about information regarding the first-wave peak period in Brazil. Descriptive analyses of background characteristics, perceptions of preparedness, and psychological impact were calculated. Multiple logistic regression analysis was performed, and independent variables that showed p < 0.20 were used in the adjusted logistic regression model to compare the psychological impact on dental professionals. Among the 2113 respondents, female participants had 63% lower chance of reporting anxiety than males. Older dentists had a lower likelihood of reporting anxiety compared to 21-30-year-old dentists (p ≤ 0.05). Dentists working in the public health service were 1.78 times more likely to report anxiety than those who worked in private practice. Finally, dentists in the COVID-19 high-risk group and those with a family or team member with a positive COVID-19 diagnosis were more likely to have anxiety. This study can help dental and other healthcare professionals to better understand the consequences of COVID-19 in terms of mental health.

A importância dos estudos clínicos randomizados e seu impacto na tomada de decisão clínica / The importance of randomized clinical trials and their impact on clinical decision making

Os ensaios clínicos randomizados (ECRs) são considerados o padrão ouro e o mais alto nível de evidência científica para estudos de intervenção, precedidos apenas pela síntese dos mesmos (revisões sistemáticas). Tanto os responsáveis pela tomada de decisões, quanto os desenvolvedores de diretrizes precisam usar tais estudos, bem como suas sínteses, para desenvolver diretrizes clínicas de alta qualidade para auxiliar os profissionais na tomada de decisões. Portanto, os ECRs precisam ser bem delineados para minimizar o risco de viés, a fim de construir evidências científicas confiáveis em relação aos benefícios e efeitos colaterais das intervenções clínicas, bem como para garantir a transparência na concepção da metodologia de estudo e na comunicação dos resultados. Ensaios clínicos mal delineados representam um risco para a prática clínica, assim como desperdício de tempo, esforço e recursos financeiros na ciência. Este comentário visa destacar e discutir questões relacionadas à qualidade dos ECRs e seu efeito na tomada de decisões clínicas, bem como enfatizar a conscientização sobre a necessidade de avaliar criteriosamente os ensaios clínicos que serão utilizados para embasar a prática clínica.

Randomized clinical trials (RCTs) are considered the gold standard and the highest level of scientific evidence, preceded only by systematic reviews with or without meta-analysis. Both policy makers and guideline developers need to use such studies, as well as systematic reviews of RCTs, to develop high-quality clinical guidelines to assist dentists in making clinical decisions. Therefore, randomized controlled trials need to be well designed and have a reduced number of systematic errors to build reliable scientific evidence regarding the benefits and side effects of clinical interventions, as well as to ensure transparency in the design of study methodology and reporting of results, all of which will reduce potential biases. Poorly designed clinical trials pose a risk to clinical practice, as well as a waste of time and effort for dentists and even a waste of resources in science. This commentary aims to highlight and discuss problems related to the quality of randomized controlled clinical trials and their effect on dental surgeons' clinical decision making, as well as emphasizing the importance of choosing high quality clinical trials as a basis for their clinical practice.

Clinical Accuracy of Two Different Criteria for the Detection of Caries Lesions around Restorations in Primary Teeth.

This is a delayed-type cross-sectional prospective accuracy study nested in a randomized clinical trial. The aim was to investigate the diagnostic accuracy of two visual criteria for caries lesions detection around restorations in primary teeth: the International Dental Federation (FDI) criteria, considering adaptation, staining, and the presence of caries, and the Caries Associated with Restorations and Sealants (CARS) system. For this, one examiner made the diagnosis and subsequent treatment decision using visual assessment in 163 children (3-10 years old) with both FDI and CARS criteria. The order of criteria used was defined by randomization. The reference standard was composed of two approaches: (1) the presence of carious tissue after restoration removal and (2) the presence of caries lesions after 6 and 12 months of follow-up. Sensitivity, specificity, and accuracy parameters were calculated at the dentin threshold. Poisson multilevel regression analyses were performed to evaluate the association of the diagnostic methods and other explanatory variables with the outcomes. Of the 651 restorations included, 480 were evaluated by the reference standard methods and were analyzed. The CARS system presented higher accuracy (0.721) than those obtained with FDI recurrence of caries (0.702), FDI marginal adaptation (0.700), and FDI marginal staining criteria (0.681). The FDI marginal staining showed the study's lowest sensitivity (0.280) and accuracy (0.681) values. The specificity values of FDI recurrence of caries and FDI marginal adaptation were lower than the CARS system. Restorations assessed after the follow-up period resulted in lower sensitivity but higher specificity than those replaced after initial evaluation. In conclusion, the CARS system is more accurate in detecting caries around restorations in primary teeth than the FDI system, in general. However, the FDI recurrence of caries and FDI marginal adaptation present similar performance to the CARS system when the dentin threshold is considered. On the other hand, marginal staining is not an accurate parameter to evaluate caries around restorations.

Effectiveness of Violet LED alone or in association with bleaching gel during dental photobleaching: A Systematic Review.

AIMS: To conduct a systematic review to determine the efficacy of violet led in promoting dental bleaching by itself or accelerating dental bleaching when associated with peroxides. METHODS: Clinical and in vitro studies were identified by a search on November 27th 2020 in the PubMed and Scopus databases. Inclusion criteria were: 1) studies related to bleaching; 2) studies related to violet LED Light (405-410nm); and 3) studies that analyzed efficacy. The authors assessed the studies for risk of bias independently. Authors extracted outcomes including color change evaluation and pain assessment independently. RESULTS: During the search process, 895 articles were found in the previously cited databases. After the first screening consisting of title and abstract evaluations, 18 articles were selected. Finally, 13 articles met the eligibility criteria and were included in this review, being 5 clinical trial/case series and 8 in vitro studies. In vitro studies showed a high risk of bias and interventional studies showed a low risk of bias. CONCLUSION: The violet Led seems to have the potential to bleach teeth without peroxides, with a clinical perceptible color alteration. However, the effect is small in comparison to bleaching using peroxides. When Violet Led is used in association with peroxides, it seems to potentialize the bleaching result. However, due to the high heterogeneity between studies, a small number of clinical studies, and the high risk of bias of the in vitro included studies, the results are not definitive, and further well-designed studies are needed to reach safe evidence.