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).

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.

Impact of visual inspection and radiographs for caries detection in children through a 2-year randomized clinical trial: The Caries Detection in Children-1 study.

BACKGROUND: Visual inspection (VIS) with radiographic examination (RAD) is the recommended diagnostic strategy for detecting caries in children; however, this recommendation is based on accuracy studies. The authors conducted a clinical trial to compare the detection and subsequent treatment of carious lesions in primary molars performed with VIS alone and with RAD. METHODS: Children (3-6 years old) were randomly assigned to 2 groups according to the diagnostic strategy used for caries detection on primary molars: VIS or RAD. Participants were diagnosed and treated according to the management plan related to the allocated group. The primary outcome was the number of new operative interventions during the 2-year follow-up period. Other secondary outcomes were also compared. Comparisons were performed with Mann-Whitney test using an intention-to-treat approach. RESULTS: Of the 252 children included and randomized, 216 were followed-up after 2 years (14.3% attrition rate). There was no difference between the groups for the primary outcome (P = .476). For the secondary outcomes, the RAD group had more restoration replacements (P = .038) and more restorations performed since the beginning of the study (P = .038) compared with the VIS group. In addition, the RAD group had a higher number of false-positive results than the VIS group (P < .001). CONCLUSIONS: Simultaneous use of VIS and RAD for caries diagnosis in primary molars of children who seek dental treatment does not provide additional benefits compared with VIS alone. PRACTICAL IMPLICATIONS: Dentists should perform VIS only, not RAD, for detecting carious lesions in preschool-aged children. ClinicalTrials.gov: NCT02078453.

Impact of the radiographic method on treatment decisions related to dental caries in primary molars: a before-after study.

OBJECTIVES: To evaluate the impact of radiographic examination on changes of treatment decision related to dental caries compared to decisions guided by visual inspection alone in primary molars. MATERIALS AND METHODS: A total of 126 children aged 3-6 years who had sought dental assistance were randomly selected and examined by two calibrated examiners using visual inspection. A treatment plan regarding dental caries was generated based on this assessment. The same examiners then evaluated two bitewing radiographs, creating an additional treatment plan guided by concurrent assessment of both visual and radiographic methods. Occlusal and proximal surfaces of primary molars received a treatment decision as follows: (i) no treatment, (ii) non-operative treatment, and (iii) operative treatment. The frequency of changes in the treatment decision after radiographic examination was calculated, with subsequent Poisson multilevel regression analysis to evaluate variables influencing such changes. RESULTS: Changes from "no treatment" decided with visual inspection to "non-operative treatment" after radiographic evaluation occurred in 52 surfaces (3.2%), and changes to "operative treatment" were observed in 46 dental surfaces (2.8%). Furthermore, 50 surfaces (6.2%) had their treatment decision changed from non-operative to operative treatment after radiographic assessment. In addition, changes were significantly more frequent in children with higher caries experience, on proximal surfaces and in 1st primary molars. CONCLUSIONS: The impact of radiographic examination on changes in the treatment decision of primary molars made with visual inspection is modest. Changes are more frequent in children with higher caries experience and in proximal surfaces. CLINICAL RELEVANCE: The benefits of the radiographic method for detecting caries in children, as a protocol in the diagnostic process, seem to be overestimated; the impact of this method on changes in treatment decision made by visual examination alone is low. Radiographs could be, however, useful in particular conditions, such as in children with high caries experience.

The Influence of Cognitive Bias on Caries Lesion Detection in Preschool Children.

We aimed to evaluate whether children's caries experience exerts an influence on the performance of visual and radiographic methods in detecting nonevident proximal caries lesions in primary molars. Eighty children (3-6 years old) were selected and classified as having a lower (≤3 decayed, missing, or filled surfaces; dmf-s) or higher (> 3 dmf-s) caries experience. Two calibrated examiners then assessed 526 proximal surfaces for caries lesions using visual and radiographic methods. As a reference standard, 2 other examiners checked the surfaces after temporary separation. Noncavitated and cavitated lesion thresholds were considered and Poisson multilevel regression analyses were conducted to evaluate the influence of caries experience on the performance of diagnostic strategies. Accuracy parameters stratified by caries experience were also derived. A statistically significant influence of caries experience was observed only for visual inspection, with more false-positive results in children with a higher caries experience at the noncavitated lesion threshold, and more false results at the cavitated threshold. The detection of noncavitated caries lesions in children with a higher caries experience was overestimated (specificity = 0.696), compared to children with a lower caries experience (specificity = 0.918), probably due to confirmation bias. However, the examiners underestimated the detection of cavitated lesions in children with a higher caries experience (sensitivity = 0.143) compared to lower-caries-experience children (sensitivity = 0.222), possibly because of representativeness bias. The radiographic method was not influenced by children's caries experience. In conclusion, children's caries experience influences the performance of visual inspection in detecting proximal caries lesions in primary teeth, evidencing the occurrence of cognitive biases.