BackgroundThe responsiveness of the Early Childhood Oral Health Impact Scale (ECOHIS) has varied greatly across studies; hence, we hypothesized that this discrepancy could be related to the complexity of dental treatment received. Thus, we aimed to evaluate the responsiveness of the ECOHIS to changes in oral health-related quality of life (OHRQoL) following dental treatments of varying complexity in preschool children.MethodsPreschool children aged 3 to 6 years were selected; their parents responded to the ECOHIS at baseline. The parents responded to the ECOHIS again and a global transition question 30 days after the children were treated. The type of treatment received by the children was categorized according to complexity, as follows: 1) non-operative treatment only, 2) restorative treatment, and 3) endodontic treatment and/or tooth extraction. Change scores and effect sizes (ES) were calculated for total scores, as well as considering the different treatment types and global transition question responses.ResultsOf the 152 children who completed the study, the ECOHIS yielded large ES for total scores (0.89). The children showed increasing ES values associated with better perception of improvement, assessed by the global transition question. The magnitude of ES after treatment was related to treatment complexity (0.53, 0.92 and 1.43, for children who received non-operative treatment only, restorative treatment, and endodontic treatment and/or tooth extraction, respectively).ConclusionsParents whose children required more complex dental treatment are more likely to perceive treatment-related changes to OHRQoL assessed with the ECOHIS.Electronic supplementary materialThe online version of this article (doi: 10.1186/s12955-017-0756-z) contains supplementary material, which is available to authorized users.

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).

Background To evaluate the clinical course and interventions required during two years of follow-up of dental surfaces of deciduous molars diagnosed, and consequently treated, by two different strategies: diagnosis made by clinical examination alone or associated with radiographs. Methods This is a secondary analysis of a two-arm randomized clinical trial with parallel groups related to the diagnostic strategy for caries detection in preschool children. 216 children (3–6 years old) were followed-up for two years. All dental surfaces were diagnosed by visual inspection and later, through radiographic assessment. Baseline treatment was made in accordance with the results obtained by visual inspection performed alone or combined with radiographic method, considering the allocated group. Dental surfaces with no restoration needs, or those restored at the beginning of the study were followed-up for two years. The treatment decision was made according to the allocated group. The outcome was the occurrence of failure (a new caries lesion or a restoration replacement) during the follow-up. Results 4383 proximal and occlusal surfaces of deciduous molars in 216 preschool children were diagnosed and treated according to the abovementioned diagnostic strategies and followed-up for 24 months. The assessment of radiographs made change the initial decision reached by visual inspection in about 30% of the surfaces when all types of interventions were considered. However, most disagreements occurred for initial lesions, where radiographs tended to underestimate them. Discordances between methods occurred in less than 5% of all surfaces when considered lesions requiring operative treatment. For discrepancy cases, the placed interventions guided by following the radiographic results did not present less failures against those made following only visual inspection. As a matter of fact, the use of radiographs in the diagnostic strategy for caries detection in children brought more harms than benefits due to the occurrence of false-positives, overdiagnosis and lead-time bias. Conclusions Simultaneous association of visual inspection and radiographic assessment for caries detection in preschool children causes more harms than benefits, and therefore, visual inspection should be conducted alone in the regular clinical practice. Trial registration Clinicaltrials.gov platform: NCT02078453, registered on 5th March 2014.

Background Dentin hypersensitivity (DH) is a common problem in the population that can have a significant impact on the quality of life of those who suffer from the condition. Objectives Compare the efficacy of two treatments for DH: Ca/PO4−/F− varnish (Clinpro White Varnish) and ionomeric sealant (IS) (Clinpro XT Varnish) with a placebo. Methods Participants (121) with at least one tooth with visual analogue scale (VAS) score of 4 and above were randomly and blindly allocated to the groups. Treatments were performed by a trained researcher. DH was evaluated by another blind researcher after the treatment and after 1 week, 4 weeks, 3 months and 6 months. After 4 weeks, placebo received the DH treatment with IS; thus, the participants were not assessed after 3 and 6 months. Primary outcome was DH reduction after 4 weeks. Differences in VAS scores in the other time intervals and entire values of VAS were considered secondary outcomes. Comparisons were made among the groups (α = 0.05). Results IS showed the highest VAS value difference between baseline and 4 weeks (mean ± SD: 3.7 ± 2.2), differing significantly from placebo (2.3 ± 1.7) and Ca/PO4/F− varnish (2.6 ± 2.0). Ca/PO4−/F− varnish did not differ from placebo. In all time intervals, VAS values of all groups were significantly lower than the baseline value, without differences among groups. For the long‐term differences in VAS values (3 and 6 months), the IS exhibited significantly higher values than Ca/PO4−/F− varnish. Conclusions The IS was the most efficacious product for reducing DH, whereas Ca/PO4−/F− varnish did not differ from placebo. Registered in ClinicalTrials.gov (NCT04591444).

ObjectiveThis 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 MethodsThis 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.ResultsTwo 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.ConclusionCaries 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.