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This scoping review aimed to identify, describe, and analyze the use of Atraumatic Restorative Treatment (ART) as public policy. Inclusion criteria: studies on public oral health policies; dental caries; ART. Exclusion criteria: clinical studies; specific interventions; studies that report public policies that do not use ART as a strategy for caries treatment. The search was conducted in PubMed, BVS, Epistemonikos, Health Systems Evidence, and Rxforchange. The selection process and data extraction were performed by two authors independently according to the stages and categories of a conceptual framework. Of the 2253 eligible articles, 139 were duplicates, and 1680 were not included after reading the title and abstract. After assessing the full text, 414 articles were excluded. Twenty articles were included. Nineteen were conducted in nine countries (South Africa, Bolivia, Cambodia, Egypt, Mexico, Tanzania, East Timor, Tunisia, and Zimbabwe), and one in the Americas. The studies reported high prevalence of dental caries and lack of access to restorative procedures in health services as common problems. Policy developments followed a similar process, with the presence of governments, conceptual use of scientific evidence, and induction by the World Health Organization. Regarding implementation barriers, the included studies mentioned the lack of supplies and lack of induction by managers,while in relation to the facilitators, permanent education and professional practice were mentioned. Cohort studies have shown a survival rate greater than 80% after one year of follow up of the restorations performed. The findings of this review indicate that the use of ART in public policies is promising, however, its use is still in an early stage. (AU)

Esta revisão de escopo teve como objetivo identificar, descrever e analisar o uso do Tratamento Restaurador Atraumático (ART) como política pública. Critérios de inclusão: estudos sobre políticas públicas de saúde bucal; cáries dentárias; ART. Critérios de exclusão: estudos clínicos; intervenções específicas; estudos que relatam políticas públicas que não utilizam o ART como estratégia para o tratamento de cárie. A pesquisa foi realizada no PubMed, BVS, Epistemonikos, Health Systems Evidence e Rxforchange. O processo de seleção e extração de dados foram realizados por dois autores, de forma independente, de acordo com as etapas e categorias de um quadro conceitual. Dos 2.253 artigos elegíveis, 139 eram duplicados e 1.680 não foram incluídos após a leitura do título e do resumo. Após avaliação do texto completo, foram excluídos 414 artigos. Vinte artigos foram incluídos. Dezenove foram realizados em nove países (África do Sul, Bolívia, Camboja, Egito, México, Tanzânia, Timor Leste, Tunísia e Zimbábue) e um nas Américas. Os estudos relataram alta prevalência de cárie dentária e falta de acesso a procedimentos restauradores nos serviços de saúde como problemas comuns. Os desenvolvimentos de políticas seguiram um processo semelhante, com a presença de governos, uso conceitual de evidências científicas e indução da Organização Mundial da Saúde. Quanto às barreiras de implementação, foram mencionadas a falta de insumos e a falta de indução por parte dos gestores. Quanto aos facilitadores, foram citados a educação permanente e a prática profissional. Estudos de coorte mostraram sobrevida superior a 80% após um ano de acompanhamento. Os achados desta revisão indicam que a utilização da ART nas políticas públicas é promissora, porém, sua utilização ainda é incipiente. (AU)

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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.

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OBJECTIVE: This randomized clinical trial aimed to evaluate the influence of two caries diagnosis strategies, and subsequent management, on oral health-related quality of life (OHRQoL) of preschoolers. Additionally, the association of the OHRQoL outcomes with the clinician-centred primary outcome used in the main study was also explored. MATERIALS AND METHODS: This study refers to the OHRQoL secondary outcomes analyses of the so-called RCT 'CARDEC-1'. Three- to 6-year-old children were randomly allocated in two caries detection strategies in primary molars: visual inspection (VIS) or visual + radiographic (RAD) assessment. Participants were diagnosed and treated according to the allocated group and followed up for 2 years. Caregivers answered the Early Childhood Oral Health Impact Scale (ECOHIS) at baseline and after 2 years. Intention-to-treat analysis was performed. ECOHIS scores at baseline and 2 years later were compared using the Mann-Whitney test. Effect sizes, change scores and the minimally important difference (MID) were also compared between groups. Additional analysis was performed to assess if OHRQoL variables could reflect the primary clinical outcome (number of new operative interventions during the follow-up), observing if these met the Prentice criteria. RESULTS: Two hundred and five children had the ECOHIS answered in both period times (18.7% attrition rate). There was a decrease in total ECOHIS scores, as well as for different domains for both trial groups, with effect sizes varying from 0.43 to 0.77. Comparisons between groups, however, did not show significant differences. In the additional analysis, the OHRQoL variables met the Prentice criteria and presented the same trends observed with the clinician-centred primary endpoint. CONCLUSION: Caries detection performed by visual inspection alone or associated with radiographic method does not influence the long-term impact on OHRQoL. Furthermore, OHRQoL variables reflect clinical outcomes in this type of clinical trial. CLINICALTRIALS: gov NCT02078453.

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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.

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BACKGROUND: Different approaches have been used by dentists to base their decision. Among them, there are the aesthetical issues that may lead to more interventionist approaches. Indeed, using a more interventionist strategy (the World Dental Federation - FDI), more replacements tend to be indicated than using a minimally invasive one (based on the Caries Around Restorations and Sealants-CARS). Since the resources related to the long-term health effects of these strategies have not been explored, the economic impact of using the less-invasive strategy is still uncertain. Thus, this health economic analysis plan aims to describe methodologic approaches for conducting a trial-based economic evaluation that aims to assess whether a minimally invasive strategy is more efficient in allocating resources than the conventional strategy for managing restorations in primary teeth and extrapolating these findings to a longer time horizon. METHODS: A trial-based economic evaluation will be conducted, including three cost-effectiveness analyses (CEA) and one cost-utility analysis (CUA). These analyses will be based on the main trial (CARDEC-03/ NCT03520309 ), in which children aged 3 to 10 were included and randomized to one of the diagnostic strategies (based on FDI or CARS). An examiner will assess children's restorations using the randomized strategy, and treatment will be recommended according to the same criteria. The time horizon for this study is 2 years, and we will adopt the societal perspective. The average costs per child for 24 months will be calculated. Three different cost-effectiveness analyses (CEA) will be performed. For CEAs, the effects will be the number of operative interventions (primary CEA analysis), the time to these new interventions, the percentage of patients who did not need new interventions in the follow-up, and changes in children's oral health-related quality of life (secondary analyses). For CUA, the effect will be tooth-related quality-adjusted life years (QALYs). Intention-to-treat analyses will be conducted. Finally, we will assess the difference when using the minimally invasive strategy for each health effect (∆effect) compared to the conventional strategy (based on FDI) as the reference strategy. The same will be calculated for related costs (∆cost). The discount rate of 5% will be applied for costs and effects. We will perform deterministic and probabilistic sensitivity analyses to handle uncertainties. The net benefit will be calculated, and acceptability curves plotted using different willingness-to-pay thresholds. Using Markov models, a longer-term economic evaluation will be carried out with trial results extrapolated over a primary tooth lifetime horizon. DISCUSSION: The main trial is ongoing, and data collection is still not finished. Therefore, economic evaluation has not commenced. We hypothesize that conventional strategy will be associated with more need for replacements of restorations in primary molars. These replacements may lead to more reinterventions, leading to higher costs after 2 years. The health effects will be a crucial aspect to take into account when deciding whether the minimally invasive strategy will be more efficient in allocating resources than the conventional strategy when considering the management of restorations in primary teeth. Finally, patients/parents preferences and consequent utility values may also influence this final conclusion about the economic aspects of implementing the minimally invasive approach for managing restorations in clinical practice. Therefore, these trial-based economic evaluations may bring actual evidence of the economic impact of such interventions. TRIAL REGISTRATION: NCT03520309 . Registered May 9, 2018. Economic evaluations (the focus of this plan) are not initiated at the moment.

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BACKGROUND: Glass ionomer cements (GIC) have been considered the top option to restore primary teeth by dentists. The most common supply forms are hand mixed and encapsulated GIC. There is a lack of information about the impact of different GIC supply forms on restoration survival. METHODS: This randomized clinical trial compared the survival rate of occlusal and occlusoproximal restorations in primary molars using two glass ionomer cements versions: hand-mixed (H/M) and encapsulated (ENC) after 24 months. Children aged 3-10 years who presented dentin caries lesions in primary molars were selected at School of Dentistry, University of São Paulo, Brazil. They were randomly assigned to groups: H /M (Fuji IX®, GC Europe) or ENC (Equia Fill®, GC Europe). The occurrence of restoration failure was evaluated by two blinded and calibrated examiners. The analyses were performed in Stata 13 (StataCorp, USA). To evaluate the primary outcome (restoration survival), we  performed a survival analysis. Additionally an intention to treat (ITT) analysis were done at 24 months of follow-up. Cox Regression with shared frailty was performed to assess association between restoration failure and independent variables (α = 5%). RESULTS: A total of 324 restorations were performed in 145 children. The survival for H/M group was 58.2% and 60.1% for ENC, with no difference (p = 0.738). Occlusoproximal restorations had lower survival rate when compared to occlusal ones (HR = 3.83; p < 0.001). CONCLUSIONS: The survival rate in primary molars is not influenced by the different supply forms of GIC. Also, occlusoproximal restorations present reduced performances when compared to occlusal cavities. TRIAL REGISTRATION: This randomized clinical trial was registered on ClinicalTrials.Gov on 10/15/2014 under protocol (NCT02274142).

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Economic evaluations in Dentistry have been increasing in recent years. They are a relevant contribution if an economic issue exists. Knowing if a new intervention is an efficient way of allocating available (and scarce) resources (the concept of opportunity costs), a well-designed economic evaluation may be helpful. One option is to conduct a trial-based economic analysis, which extracts a considerable board of information from a trial. This approach produces a more controlled result since many sources of variations might be reduced. On the other hand, some aspects could not be predicted directly from the trial or even extrapolated. Thus, combining model-based analysis may be an idea. In this paper, we intended to discuss important aspects to be considered by researchers in further economic evaluations. This paper will be systematically divided into sessions related to the study design as time horizon and perspective, health effects, costs, and data analysis. In the end, we expect the reader could be able to plan a trial-based economic evaluation, which should be a careful, meticulous, quite laborious and especially transparent process.

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Introduction: The detection of caries lesions around restoration can be challenging. Therefore, the use of some criteria has been proposed in order to give more objectivity to the diagnosis process. Two of them are the International Dental Federation (FDI) and the Caries Associated with Restorations and Sealants (CARS) criteria. Both methods have a different approach to caries, and it is not possible to know which one of them is the best to use in clinical practice to assess restorations in children. Thus, the present protocol aims to evaluate the effect of the use of the FDI and CARS criteria in the assessment of caries lesions around restorations in primary teeth on outcomes related to oral health in children and costs resulting from the assessments. Methods and analysis: A total of 626 restorations of children from three to 10 years were randomly assessed and are being treated following the FDI criteria (FDI group) or CARS criteria (CARS group). Participants will be followed-up after six, 12, 18, and 24 months. The primary outcome will be the need for a new intervention in the evaluated restorations. This outcome consists of several components, and each of these events will be analyzed separately as secondary outcomes. The changes in children's oral health-related quality of life and the cost of the restoration dental treatments will also be analyzed as secondary outcomes. The methods will be compared using the Cox regression model with shared frailty. A significance level of 5% will be adopted for all statistical analyses. Discussion: This will be the first randomized clinical study carried out regarding the detection of caries lesions around restorations in primary teeth. Trial registration: The study underwent registration in Clinicaltrials.gov ( NCT03520309) on 9 May 2018.

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Abstract Economic evaluations in Dentistry have been increasing in recent years. They are a relevant contribution if an economic issue exists. Knowing if a new intervention is an efficient way of allocating available (and scarce) resources (the concept of opportunity costs), a well-designed economic evaluation may be helpful. One option is to conduct a trial-based economic analysis, which extracts a considerable board of information from a trial. This approach produces a more controlled result since many sources of variations might be reduced. On the other hand, some aspects could not be predicted directly from the trial or even extrapolated. Thus, combining model-based analysis may be an idea. In this paper, we intended to discuss important aspects to be considered by researchers in further economic evaluations. This paper will be systematically divided into sessions related to the study design as time horizon and perspective, health effects, costs, and data analysis. In the end, we expect the reader could be able to plan a trial-based economic evaluation, which should be a careful, meticulous, quite laborious and especially transparent process.

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We aimed to investigate the performance of fluorescence-based methods (FBMs), compared to visual inspection after histological validation, in detecting and assessing the activity status of occlusal carious lesions in primary teeth. One examiner evaluated 50 primary molars close to exfoliation in 24 children. Teeth were assessed using quantitative light-induced fluorescence (QLF) and pen-type laser fluorescence (LFpen). After exfoliation, histological validation was performed. Teeth were cut and sections were evaluated for lesion depth and activity status (after utilization of a pH indicator) under a stereomicroscope. Parameters related to the performance of the methods in detecting caries lesions at two thresholds (initial and dentin lesions) were calculated. Regarding the activity status, lesions were classified into sound+inactive or active, and the area under the ROC curve and the diagnostic odds ratio values of the methods were calculated and compared. Evaluation of red fluorescence using QLF presented higher sensitivity but lower specificity than visual inspection in detecting dentin caries lesions. However, QLF considering different parameters and LFpen had similar performance to that obtained with visual inspection. Regarding activity assessment, all FBMs and visual inspection also presented similar performance. In conclusion, FBMs did not prove advantageous for the detection and activity assessment of occlusal caries lesions in primary molars when compared to visual inspection.

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