Factors influencing the impact of randomized clinical trials on dental implants: A bibliometric analysis.

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.

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.

A scoping review of guidelines on caries management for children and young people to inform UK undergraduate core curriculum development.

BACKGROUND: Current evidence in cariology teaching is not consistently reflected in paediatric dentistry in the United Kingdom (UK). Many dental schools are not consistently teaching biological approaches to caries management, with outdated or complex methods being taught outwith the purview of general dental practitioners. This scoping review aimed to map current guidelines on the management of caries in children and young people. This is part of a work package to inform the consensus and development of a UK-wide caries management curriculum for paediatric dentistry. METHODS: A search of electronic databases for peer reviewed literature was performed using Cochrane Library, MEDLINE via PubMed, TRIP Medical Database and Web of Science. Hand searching was undertaken for grey literature (citations of sources of evidence, websites of global organisations and Google Web Search™ (Google LLC, California, USA). Results from databases were screened independently, concurrently by two reviewers. Full texts were obtained, and reviewers met to discuss any disagreement for both database and hand searching. RESULTS: This review identified 16 guidelines suitable for inclusion. After quality appraisal, eight were selected for synthesis and interpretation. Key themes included the shift towards selective caries removal and avoidance of complete caries removal unless in specific circumstances in anterior teeth. For "early lesions" in primary and permanent teeth with and without cavitation, several guidelines recommend biological management including site specific prevention and fissure sealants. CONCLUSIONS: This review mapping current cariology guidelines for children and young people found gaps in the literature including classification of early carious lesions and management of early cavitated lesions. Areas identified for further exploration include integration of biological caries management into treatment planning, selective caries removal and whether pulpotomy is specialist-level treatment, requiring referral. These results will inform consensus recommendations in the UK, using Delphi methods.

2-year survival and cost analysis of occlusoproximal ART restorations using encapsulated glass ionomer cement in primary molars: a randomized controlled trial.

BACKGROUND: The survival of ART restorations can be influenced by the choice of the restorative material. The aim of this randomized non-inferiority controlled trial was to compare the 2-year survival rate and cost analysis of two encapsulated glass ionomer cements (GIC) as occlusoproximal restorative materials in primary molars. METHODS: Children from public schools in Tietê (Brazil), aged 4-8 years with occlusoproximal dentine carious lesions in primary molars were selected and randomly assigned to receive either Equia Forte (EF) or Riva Self Cure (RSC) as restorative materials. Treatment was carried out by two trained final-year dental students in schools following ART premises. Restorations were assessed by a trained and calibrated examiner after 2, 6, 12, 18, and 24 months. The primary outcome was restoration survival after 2 years, analyzed using Kaplan-Meier survival and Cox regression analysis (α = 5%). Professional and materials costs for each group were collected in Brazilian Reais (R$) and converted into US dollars (US$) and analyzed using Monte-Carlo simulation. RESULTS: A total of 152 children (76 per group) were included in the study, and 121 (79%) were evaluated after 2 years. The overall 2-year restoration survival rate was 39% (EF = 45%; RSC = 32%) with no difference between the groups. The baseline and 2-year total cost of restorations using RSC was lower when compared to EF (incremental cost: US$ 6.18). CONCLUSION: After two years of follow-up, Riva Self Cure shows comparable restoration survival rates to Equia Forte, being more cost-effective in the Brazilian perspective. TRIAL REGISTRATION: This randomized clinical trial was registered on ClinicalTrials.Gov - NCT02730000.

CONSORT statement adherence and risk of bias in randomized controlled trials on deep caries management: a meta-research.

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 ).

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 .

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.

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.

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.

Nonrestorative treatment of initial caries lesion in primary teeth: a systematic review and network meta-analysis.

OBJECTIVE: To identify the best available approach to avoid initial caries lesions progression in primary teeth. MATERIALS AND METHODS: Search was performed in MEDLINE/Pubmed, Web of Science, Embase and CENTRAL databases until March 2021. Studies compared treatment options to avoid the initial caries lesion progression with at least 12 months of follow-up were included. Network meta-analyses were conducted considering the non-progression of caries lesions as an outcome. RESULTS: Potentially eligible studies were screened (n = 2820) and eleven were included. Six studies evaluated the use of fluoride varnish, resin infiltration, sealing, and toothbrushing/flossing on proximal initial caries lesions. When considering occlusal surfaces, only two studies evaluating the ozone gas, fluoride varnish, resin infiltration, and sealants were included. For buccal/lingual surfaces, three studies evaluating toothbrushing, CPP-ACP paste, fluoride varnish, and resin infiltration were included. For all types of surfaces, the resin infiltration showed the best probability to avoid the progression of initial caries lesions. CONCLUSION: The limited number of included studies, most with a high risk of bias and lack of hard outcomes, such as frank cavitation, makes it not feasible to recommend a specific management approach for initial caries lesion control in primary teeth with a high certainty of evidence. PROSPERO: #CRD42016037781.

Stainless steel crown vs bulk fill composites for the restoration of primary molars post-pulpectomy: 1-year survival and acceptance results of a randomized clinical trial.

BACKGROUND: A key factor for the success and longevity of the endodontic treatment is sealing of the cavity after restorative treatment. AIM: The aim of this randomised clinical trial was to evaluate the 1-year survival of endodontic treatment in primary molars restored with stainless steel crowns (SSCs) and bulk fill composite resin (BF). As a secondary outcome, the acceptance of both children and parents was evaluated. DESIGN: Ninety-one 3- to 8-year-old children with at least one primary molar requiring endodontic treatment were selected. Participants were randomized to SSC or BF and evaluated after 1, 3, 6, and 12 months. An acceptance questionnaire was completed immediately after the treatment. The primary outcome was the endodontic treatment success, evaluated in the intention-to-treat (ITT) population using the Kaplan-Meier and non-inferiority Cox regression analyses, with a non-inferiority limit of 15%. Sensitivity analysis between the success rates after 1 year was performed using Miettinen-Nurminen's method. The Mann-Whitney test was used to compare the treatment acceptance (α = 5%). RESULTS: The survival rate after 1 year was BF = 75% and SSC = 88% (HR = 1.41; 90% CI 0.57-3.43). ITT analysis showed a success rate of BF = 86.7% and SSC = 82.6% (RR = 0.95; 0.78-1.16). The non-inferiority hypothesis between the survival of endodontic treatment could not be proved in both analyses (P > .05). The overall acceptance scores did not differ between the restorative groups (P > .05). CONCLUSION: This study failed to show non-inferiority of BF compared with the SSC. The materials were well accepted by both children and their parents.

Use of rubber dam versus cotton roll isolation on composite resin restorations' survival in primary molars: 2-year results from a non-inferiority clinical trial.

BACKGROUND: This non-inferiority randomised clinical trial aimed to evaluate the survival of direct bulk fill composite resin restorations in primary molars using different methods of moisture control: rubber dam isolation (RDI-local anaesthesia and rubber dam) and cotton roll isolation (CRI-cotton roll and saliva ejector). Secondary outcomes included baseline and 2-year incremental cost, self-reported child's pain scores and patient behaviour during the restorative procedure. METHODS: A total of 174 molars (93 children) with dentine caries lesions were randomly allocated to study groups (RDI or CRI) and restored with bulk fill composite resin by trained operators. Two blinded examiners assessed the restorations for up to 24 months. Wong-baker faces and Frankl's behaviour rating scales were used for accessing the child's pain and behaviour, respectively. The primary outcome (restoration survival) was analysed using the two-sample non-inferiority test for survival data using Cox Regression (non-inferiority/alternative hypothesis HR > 0.85; CI = 90%). Bootstrap Linear regression was used for cost analysis and logistic regression for pain and behaviour analysis (α = 5%). RESULTS: After 2-years, 157 restorations were evaluated (drop-out = 9.7%). The survival rate was RDI = 60.4% and CRI = 54.3%. The non-inferiority hypothesis was accepted by the Cox Regression analysis (HR = 1.33; 90% CI 0.88-1.99; p = 0.036). RDI was 53% more expensive when compared to the CRI group. No differences were found between the groups regarding pain (p = 0.073) and behaviour (p = 0.788). CONCLUSION: Cotton roll isolation proved to be non-inferior when compared to rubber dam for composite restorations longevity in primary molars. Furthermore, the latest presented the disadvantage of higher cost and longer procedure time. Clinical Significance The moisture control method does not influence the longevity of composite restorations in primary molars. Cotton roll isolation proved to be non-inferior to rubber dam isolation and is a viable option for restoring primary molars. Clinical trial registration registered NCT03733522 on 07/11/2018. The present trial was nested within another clinical trial, the CARies DEtection in Children (CARDEC-03-NCT03520309).

Using information and communication technologies (ICTs) to solve the repressed demand for primary dental care in the Brazilian Unified Health System due to the COVID-19 pandemic: a randomized controlled study protocol nested with a before-and-after study including economic analysis.

BACKGROUND: With the COVID-19 pandemic, thousands of children had their dental care interrupted or postponed, generating a pent-up demand for primary care. To minimize the impact of this outage, information and communication technologies (ICT) could be an alternative. The aim of this study is to elucidate the impact of implementing the ICTs in primary dental care for children on resolving the pent-up demand for primary dental care to children in the national health system service (SUS) due to the COVID-19 pandemic. METHODS: Different research strategies are being proposed to demonstrate such effect and extrapolating findings to a real-world context to guide further research, practice and policies: two clinical trials (one randomized controlled by the waiting list trial (RCT) and a before-and-after study), one simulation study to prospect trial results to a broader population and three economic evaluations using different effects. Children enrolled in a reference dental unit will be invited to participate in the before-and-after study for trials. The first 368 families will be randomized for the RCT to the intervention vs waiting list. All participants will receive the intervention, but the waiting list group will be assessed before the intervention is available for them. The intervention comprises standardized non-face-to-face primary dental care using the V4H platform. The problem-solving and the family's perception will be the primary outcomes set for the before-and-after study and RCT, respectively. They will be measured 2 weeks after randomization. Based on trial findings, we will develop theoretical models to estimate how the intervention could benefit the population included in the national health system.  Three economic evaluations will be carried out considering different trial effects (cost-effectiveness analyses). A societal perspective and the pandemic time horizon will be considered. Possible social impact (inequalities) will also be explored. DISCUSSION: This ongoing trial may be an essential contribution to clarify positive and negative aspects related to the use of technologies for non-face-to-face dental care for children. Trial products may bring relevant contributions to the pandemic context and the post-pandemic period. Potential benefits may be feasible to implement and preserve in the health system even in the post-pandemic period. Trial registration Clinicaltrials.gov registration NCT04798599 (registered March 2021).

Atraumatic Restorative Treatment-Sealed versus Nonsealed First Permanent Molars: A 3-Year Split-Mouth Clinical Trial.

To investigate the efficacy of atraumatic restorative treatment (ART) sealants vs. no sealant in preventing the development of dentine caries lesions in first permanent molars over a period of 3 years. A total of 187 schoolchildren (aged 6-8 years) from a low-income population presenting the 4 first permanent molars without clinically detectable dentine caries lesions were selected to be part of a split-mouth clinical trial. All 4 first permanent molars were investigated in this trial and the children's mouth was split vertically into left and right sides; therefore, 2 molars were randomly allocated to receive ART sealants, while the other 2 molars remained nonsealed. All children received toothbrushing instructions and dietary advice every 6 months for a period of 3 years. Clinical evaluations were performed after 3, 6, 12, 18, 24, and 36 months and both sealant retention and dental caries were scored. Kaplan-Meier survival analysis, log-rank test, and Cox regression with shared frailty analysis were performed. A cavitated dentine caries lesion was considered a failure. The cumulative survival rates of dentine cavity-free first permanent molars were 90% for ART-sealed molars and 90.8% for nonsealed molars, with no statistically significantly difference between sealed and nonsealed molars (p = 0.70). The retention of sealants was not associated with the development of cavitated dentine caries and children presenting a higher baseline caries experience had greater chances of developing dentine lesions. In conclusion, the application of ART sealants was not more efficacious than nonsealing in reducing the development of dentine cavitated lesions in first permanent molars.

Randomized clinical trial to evaluate two methods of caries risk assessment in schoolchildren: the CARDEC-PEL 04 study protocol.

BACKGROUND: Caries risk assessment is an essential element for managing and preventing dental caries in children. Individual caries risk assessment can be conducted to evaluate the presence or absence of single factors, or using multivariate models, a combination of factors. The subject has been extensively studied, but no previous research has compared whether a more elaborate and individualized method of caries risk benefits the patient than more straightforward strategies. Thus, this protocol evaluates the efficacy of two risk assessment methods for caries control in children, a simplified method based on caries experience evaluation and a multivariate method described in the literature. METHODS: This is a randomized, double-blind, controlled, parallel-treatment trial protocol. Two groups will be tested for two forms of caries risk assessment: an individualized and detailed multivariate method based on the guidelines of the Caries Care International 4D and another simplified process, based only on caries experience in primary and/or permanent dentition, considering the presence of decayed, missing and filled teeth using the DMFT/dmft index. Participants will be children aged 8 to 11 years, followed up at 12 and 24 months. The primary outcome will be a composite outcome representing the number of tooth surfaces requiring operative intervention (account variable). In addition, the Shapiro-Wilk normality test and Student's t-test will be performed. A multivariate analysis using negative binomial regression will compare groups in the intention-to-treat population, considering a two-tailed significance level of 5%. DISCUSSION: This is the first randomized clinical trial aiming to compare dental caries-related treatment and follow-up based on a detailed, multivariate and individualized assessment of caries risk in school-age children to a simpler risk assessment strategy based on caries experience. This study will define whether there are essential benefits to the patient that justify the choice of one method over the other. Trial registration Clinicaltrials.gov registration: NCT03969628. Registered on May 31th, 2019.

Sedation versus protective stabilization for dental treatment of children with caries and challenging behavior at the dentist (CHOOSE): a study protocol for a non-randomized clinical trial.

BACKGROUND: There is a lack of evidence on the effectiveness of moderate sedation in pediatric dentistry, compared to protective stabilization, which remains routinely used in Brazil despite moral questions. This prospective non-randomized clinical trial's objective is to evaluate the effectiveness of moderate sedation, compared to the protective stabilization, in the dental care of children with dental behavior management problems. METHODS: Participants will be 152 children under seven years of age with early childhood caries (ECC) who need specialized dental treatment due to a history of challenging behavior during dental care. The interventions to be compared are moderate sedation with oral administration of ketamine and midazolam and protective stabilization. The primary endpoint will be the child's behavior during treatment assessed using the Ohio State University Behavioral Rating Scale (OSUBRS). The secondary outcomes are (A) child's - behavior according to the visual analogue scale, anxiety, pain, and physiological stress; (B) parent's - satisfaction and anxiety; (C) family and child - impact on oral health-related quality of life (OHRQoL); (D) dentist's - satisfaction and stress; (E) procedure - adverse events of the intervention and dental treatment longevity. A cost-effectiveness analysis will be performed from the perspective of the Brazilian Unified Health System (SUS). DISCUSSION: Considering the primary outcome, this study hypothesis is that sedated children have better behavior during dental treatment than children whose behavior was managed by protective stabilization without sedation. Additionally, at the end of 12 months, we expect to identify participants' reported outcomes and objective measures related to dental behavior in early childhood. Trial registration Clinicaltrials.gov registration NCT04119180 on October 8th, 2019. https://clinicaltrials.gov/ct2/show/NCT04119180.

Survival rate of primary molar restorations is not influenced by hand mixed or encapsulated GIC: 24 months RCT.

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).

Influence of school environment on occurrence of traumatic dental injuries in 12 years old children.

BACKGROUND/AIM: Since children spend most of their time in school, some environmental characteristics of the schools may influence the occurrence of traumatic dental injuries (TDI). Therefore, the aim of this cross-sectional study was to assess the prevalence of TDI in 12 years old children in Quito, Ecuador, and its association with some school environmental aspects. MATERIAL AND METHODS: Six calibrated examiners evaluated 998 children from 31 public schools of Quito, to evaluate the occurrence of TDI in anterior teeth. School coordinators answered questionnaires on school physical conditions, promotion of health practices and the occurrence of negative episodes in school. The occlusion and socioeconomic status of the participants were also evaluated. Prevalence of TDI, unadjusted and adjusted by the design effect was calculated. Association between individual and contextual explanatory variables and presence of TDI were evaluated using multilevel Poisson regression analysis (P < .05). RESULTS: TDI prevalence adjusted by design effect was 20.7%. Children studying in schools with patio floor of grass and with access ramps had significantly lower prevalence of TDI than children studying in schools with patio floor of cement and with only stairs, respectively. The prevalence of TDI was also lower in children from schools that offered healthy meals or that had a proper place for oral hygiene. CONCLUSIONS: Schools with adequate physical structures and that promote health practices to their students have a lower prevalence of TDI.

Transparency in clinical trials: Adding value to paediatric dental research.

BACKGROUND: Even though considered as studies with high methodological power, many RCTs in paediatric dentistry do not have essential quality items in their design, development, and report, making results' reliability questionable, replication challenging to conduct, wasting time, money, and efforts, and even exposing the participants to research for no benefit. AIM: We addressed the main topics related to transparency in clinical research, with an emphasis in paediatric dentistry. DESIGN: We searched for all controlled clinical trials published from January 2019 up to July 2020 in the three paediatric dentistry journals with high journal Impact Factor, indexed on Medline. These papers were assessed for transparency according to Open Science practices and regarding reporting accuracy using some items required by CONSORT. RESULTS: 53.6% of the studies declared registration, 75% had sample size calculation, 98.2% reported randomisation, and from those, 65.4% explained the randomisation method. Besides that, no study shared their data, and 6.8% were published in open access format. CONCLUSIONS: Unfortunately, a large proportion of RCTs in paediatric dental research show a lack of transparency and reproducibility.

Coronavirus disease (COVID-19): Characteristics in children and considerations for dentists providing their care.

The emergence of the novel virus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing coronavirus disease (COVID-19) has led to a global pandemic and one of the most significant challenges to the healthcare profession. Dental practices are focal points for cross-infection, and care must be taken to minimise the risk of infection to, from, or between dental care professionals and patients. The COVID-19 epidemiological and clinical characteristics are still being collated but children's symptoms seem to be milder than those that adults experience. It is unknown whether certain groups, for example children with comorbidities, might be at a higher risk of more severe illness. Emerging data on disease spread in children, affected by COVID-19, have not been presented in detail. The purpose of this article was to report current data on the paediatric population affected with COVID-19 and highlight considerations for dentists providing care for children during this pandemic. All members of the dental team have a professional responsibility to keep themselves informed of current guidance and be vigilant in updating themselves as recommendations are changing so quickly.