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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

BackgroundSelective outcome reporting (SOR) is a type of bias that occurs when the primary outcome of a randomized clinical trial (RCT) is omitted or changed prospectively. We evaluated the prevalence of SOR in RCTs on restorative caries treatment in primary teeth. MethodsWe conducted an electronic search on ClinicalTrials.gov and the World Health Organization (WHO) platform up to April/2021. We included RCT protocols that tested restorative treatments in primary teeth and excluded any protocol that has not resulted in at least one publication in a peer-reviewed scienti c journal. The Chi-square test was used to detect the association between SOR and other variables (α = 5%). ResultsOut of 294 potential protocols, thirty were included. We found 34 corresponding publications and had the one that seemed to report the primary outcome and longest follow-up, resulting in 30 publications. SOR was observed in 53.3% (n=16) of the published trials and was signi cantly associated with the discrepancy in the follow-up period (p=0.017). ConclusionThere is a considerable prevalence of selective outcome reporting (SOR) on restorative trials in primary teeth. Properly pre-registered protocols and assessing them for the peer review processes will help decrease SOR. Practical implicationsRestorative treatment trials in primary teeth that selectively modify outcomes of interest have been shown to distort the treatment effect. Practitioners should avoid using restorative treatments based on misleading results in clinical practice.

Background: Unsuccessful restorative treatment of carious lesions in deciduous molars remains a priority for clinicians to resolve when caring for children's dentition. However, regardless of the material or technique used, standard restorative treatments continue to fail and present low survival rates. In an effort to solve these problems, a non-invasive technique known as the Hall Technique was developed with reduced adverse effects and is being studied over the last years, presenting great success in comparison with other restorative techniques. Thus, this systematic review and meta-analysis aim to address the question concerning the survival of preformed metal crowns using the Hall Technique for restoring deciduous molars.Methods: Electronic databases and other sources, such as gray literature will be searched. Randomized controlled trials (RCTs), and Non-Randomized studies of interventions (NRSI) will be included that assess the use of preformed metal crowns using the Hall Technique on primary molars. The outcome will be the cumulative survival rate of preformed metal crowns applied according to the Hall Technique. Two independent reviewers will perform screening, study selection, data extraction, risk of bias, and certainty of evidence assessment. Any discrepancies in opinion will be resolved by a third reviewer who is considered to be an expert in the field. Assessment of the risk of bias of included studies will be evaluated by RoB 2 and ROBINS-I tools. The certainty of evidence will be determined using the GRADE tool. Methodological heterogeneity across studies will be evaluated to determine the best model for the meta-analysis.Discussion: To the best of our knowledge, no systematic review has addressed this gap directly. Findings obtained from the review will be valuable in the decision-making process regarding the use of Hall Technique preformed metal crowns for restoration of decayed primary molars.

BackgroundSelective outcome reporting (SOR) is a type of bias that occurs when the primary outcome of a randomized clinical trial (RCT) is omitted or changed prospectively. We evaluated the prevalence of SOR in RCTs on restorative caries treatment in primary teeth.MethodsWe conducted an electronic search on ClinicalTrials.gov and the World Health Organization (WHO) platform up to April/2021. We included RCT protocols that tested restorative treatments in primary teeth and excluded any protocol that has not resulted in at least one publication in a peer-reviewed scientific journal. The Chi-square test was used to detect the association between SOR and other variables (α = 5%).ResultsOut of 294 potential protocols, thirty were included. We found 34 corresponding publications and had the one that seemed to report the primary outcome and longest follow-up, resulting in 30 publications. SOR was observed in 53.3% (n=16) of the published trials and was significantly associated with the discrepancy in the follow-up period (p=0.017).ConclusionThere is a considerable prevalence of selective outcome reporting (SOR) on restorative trials in primary teeth. Properly pre-registered protocols and assessing them for the peer review processes will help decrease SOR.Practical implicationsRestorative treatment trials in primary teeth that selectively modify outcomes of interest have been shown to distort the treatment effect. Practitioners should avoid using restorative treatments based on misleading results in clinical practice.

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.

The aim of this study was to evaluate the impact of different restorative techniques to treat deep caries lesions of primary molars on children’s self-reported discomfort. A randomized clinical trial with two parallel arms (1:1) was conducted in São Paulo, Brazil. 4-8 years-old children with at least one occlusal or occlusoproximal deep caries lesion in primary molars were selected. Molars were randomly allocated into two groups: (1) restoration performed with calcium hydroxide cement followed by high-viscosity Glass Ionomer Cement (CHC+HVGIC), and (2) HVGIC restoration. Immediately after the intervention, children reported the experienced discomfort during restoration to an external examiner using a Wong-Baker face-scale. Children’s self-reported discomfort was analyzed using Poisson regression comparing both groups and assessing other variables’ influence (α=5%). One hundred and eight children fulfilled the eligibility criteria and were randomized in the two groups (n=54). Most of the children who received CHC+HVGIC restorations reported none or minimal discomfort (83.3%). Similar scores (92.6%) were reported for those treated with HVGIC (p=0.758). The mean reported discomfort in children with CHC+HVGIC restorations was 0.37(1.01), and 0.41(1.01) for those with HVGIC restorations. Children’s self-reported discomfort was associated with age, sex, children’s cooperation, and intervention duration. We can conclude that CHC+HVGIC or HVGIC restorations result in none or minimal discomfort in the management of deep caries lesions, being considered a reliable option.

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