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).

Reparar ou substituir? quando e como intervir em restaurações defeituosas / Repair or replace? when and how to intervene in defective restorations

A alta prevalência de cárie ao redor do mundo faz com que os tratamentos restauradores figurem entre os procedimentos mais executados pelos cirurgiõesdentistas. Também é bastante comum os profissionais relatarem novas lesões de cárie ao redor das restaurações ou até mesmo fraturas parciais ou totais das mesmas, fatores que podem ser considerados como "falhas" do procedimento restaurador. Diante dessas situações, a maioria dos profissionais entende que é necessário realizar a substituição completa da restauração. No entanto, existem outras técnicas mais conservadoras e que podem ser tão efetivas quanto a substituição/troca, como por exemplo a realização de reparo das restaurações apresentando defeitos. O objetivo deste artigo é apresentar de forma clara e objetiva aos clínicos que se deparam diariamente com este cenário, qual seria o melhor momento para intervir, e quais as alternativas de tratamento, baseadas na melhor evidência científica disponível, a se realizar frente às falhas dos procedimentos restauradores, sempre alinhadas com a filosofia de Mínima Intervenção.

The high prevalence of caries worldwide makes restorative treatments some of the most commonly performed dental treatments. It is pretty common to find new caries lesions around the restorations or even partial or total fractures, factors that can be considered a "failure" for the restorative procedure. In these situations, most professionals understand that it is necessary to replace the restoration, but other more conservative techniques are as effective as a replacement, such as repairing the restorations. This article aims to present a clear and evidence-based when is the best time to intervene and what is the best treatment to be carried out in case of failure of the restorative procedures, in line with Minimal Intervention principles.

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.

The economic impact of two diagnostic strategies in the management of restorations in primary teeth: a health economic analysis plan for a trial-based economic evaluation.

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.

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).

How researchers should select the best outcomes for randomised clinical trials in paediatric dentistry?

Randomised clinical trial (RCT) is the best study design to evaluate the effect of the treatment and preventive healthcare procedures. The effects of the tested treatments on patient's health are compared in terms of outcomes, which are used to evaluate the participants' health changes. However, these outcomes should be relevant for the target population. In that way, RCTs represent the type of primary study design that provides the most reliable evidence to implement therapies into the clinical practice. In this review, an outline of some aspects related to the choice of RCTs' outcomes was presented, focusing on the conduction of relevant trials in Paediatric Dentistry. The importance and necessity of defining a primary outcome were addressed, preferentially a clinically relevant endpoint. The patients should perceive this outcome, and changes in this variable should reflect directly patient's health improvement or impairment. Moreover, considerations about the objective or subjective variables, use of surrogate outcomes, and the increasing tendency to develop core outcome sets were also presented in this review. The main idea of this manuscript is the RCTs must evaluate outcomes relevant to the children's oral health in order to contribute to the implementation of treatments in the evidence-based health practice.

Influence of different clinical criteria on the decision to replace restorations in primary teeth.

OBJECTIVES: This cross-sectional study is nested in a randomized clinical trial. It was designed to evaluate the influence of using two different clinical criteria to assess caries lesion around restorations on the decision to replace restorations in primary posterior teeth. Variables that might influence this decision were also considered. METHODS: One trained and calibrated examiner assessed 550 restorations of 160 children (3-10 years old). Children were randomized to have their restorations evaluated and subsequently treated according to World Dental Federation (FDI) or Caries Associated with Restorations and Sealants (CARS) criteria. After reaching the treatment decision, the same examiner performed another evaluation using the other criteria. Spearman's correlation coefficients and 95 % confidence intervals (95 %CI) between the scores obtained with both criteria and respective treatment decisions were calculated. Poisson multilevel regression analysis were performed between the exploratory variables related to children, restored tooth and restoration assessment; the outcome variables were decisions related to restoration replacement, any operative intervention and presence of secondary caries. RESULTS: The strongest correlation observed between the methods was for recurrence of caries. A total of 94 restorations (17.1 %) were indicated for replacement with FDI criteria and 30 (5.5 %) were indicated for replacement with CARS. Besides the diagnostic method used, number of decayed teeth and restorations with two and three restored surfaces were associated with the decision of replacement and presence of recurrent caries lesions. CONCLUSIONS: The decision to replace posterior restorations in primary teeth is influenced by the criteria used for the restorations assessment and also by the children's caries experience and multisurface restorations. The restoration material did not influence the decision of restorations replacement. CLINICAL SIGNIFICANCE: The decision to replace posterior restoration in primary teeth is strongly related to the evaluation method and not only by patients' risk factors.