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

Mendes, Fausto Medeiros; Braga, Mariana Minatel; Pássaro, Ana Laura; Moro, Bruna Lorena Pereira; Freitas, Roseli Santos de; Gimenez, Thaís; Tedesco, Tamara Kerber; Raggio, Daniela Prócida; Pannuti, Cláudio Sérgio

doi:10.1111/ipd.12743

Cited by 9 publications

(12 citation statements)

References 27 publications

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“…The analysis of secondary results is prone to type II errors due to lack of statistical power. 36 A major difficulty of our study consisted of recruiting eligible children, which resulted in a small sample size and a relatively wide age group. Importantly, there…”

Section: Resultsmentioning

confidence: 99%

Comparison between the rotary (Hyflex EDM®) and manual (k-file) technique for instrumentation of primary molars: a 12-month randomized clinical follow-up study

et al. 2022

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Comparison between the rotary (Hyflex EDM ® ) and manual (k-file) technique for instrumentation of primary molars: a 12-month randomized clinical follow-up study* Rotational instrumentation is an alternative for the clinical practice of pediatric dentists. However, there are few records in the literature on the clinical and radiographic aspects of treated teeth over time. Objective:Compare instrumentation time and filling quality between manual (k-file) and rotary (Hyflex EDM ® ) files, and clinically and radiographically follow-up the treated teeth for 12 months. Moreover, the characteristics of glass ionomer restorations and their interference in the treatment prognosis over time were evaluated. Methodology: In total, 40 children with pulp involvement in primary molars received treatment with Hyflex EDM ® or manual rotary files, performed by an operator. Clinical and radiographic aspects were observed at different times to determine the effectiveness of each technique. Results:The rotary system reduced instrumentation time when compared to the use of manual files (p≤0.05), but there was no difference in filling quality between the groups (p≥0.05). Moreover, both types of instrumentation were effective for 12 months (p≥0.05), and restoration retention influenced the emergence of periapical lesions (p≤0.05). Conclusion: Although rotary files reduce clinical time, the clinical and radiographic aspects of both techniques were similar over 12 months. Moreover, restoration retention has been shown to be related to treatment prognosis.

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Section: Resultsmentioning

confidence: 99%

Comparison between the rotary (Hyflex EDM®) and manual (k-file) technique for instrumentation of primary molars: a 12-month randomized clinical follow-up study

et al. 2022

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“…This fact is supported by this study's findings, since the variables of quality of life might reflect the clinical outcome. Furthermore, the PROs outcomes are unique indicators of the impact of the disease on the patient, 4,5 being used in the interpretation of clinical findings and decision‐making treatment.…”

Section: Discussionmentioning

confidence: 99%

“…Thereby, dental caries can negatively affect the quality of life of children, impairing school performance, causing problems in speech, chewing and social interaction of children, also affecting the family core 2,3 . This scenario evidences the importance of considering patient‐centred outcomes, 4,5 such as oral health‐related quality of life (OHRQoL), in clinical studies.…”

Section: Introductionmentioning

confidence: 99%

Influence of two caries detection strategies on the quality of life of preschool children: An analysis of secondary outcomes of a 2‐Year randomized clinical trial

Freitas

Pontes

Acosta

et al. 2022

Comm Dent Oral Epid

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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.

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“…As events, we considered lesions that frankly cavitated after 1 year and surfaces that were restored or a tooth that needed to be extracted after this interval. This outcome has been considered a robust outcome to be used in trials [ 37 ]. Using it, we expect to identify which situations may lead to real matters to the participants, as needing a dental restoration.…”

Section: Discussionmentioning

confidence: 99%

How combining different caries lesions characteristics may be helpful in short-term caries progression prediction: model development on occlusal surfaces of primary teeth

et al. 2021

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Background Few studies have addressed the clinical parameters' predictive power related to caries lesion associated with their progression. This study assessed the predictive validity and proposed simplified models to predict short-term caries progression using clinical parameters related to caries lesion activity status. Methods The occlusal surfaces of primary molars, presenting no frank cavitation, were examined according to the following clinical predictors: colour, luster, cavitation, texture, and clinical depth. After one year, children were re-evaluated using the International Caries Detection and Assessment System to assess caries lesion progression. Progression was set as the outcome to be predicted. Univariate multilevel Poisson models were fitted to test each of the independent variables (clinical features) as predictors of short-term caries progression. The multimodel inference was made based on the Akaike Information Criteria and C statistic. Afterwards, plausible interactions among some of the variables were tested in the models to evaluate the benefit of combining these variables when assessing caries lesions. Results 205 children (750 surfaces) presented no frank cavitations at the baseline. After one year, 147 children were reassessed (70%). Finally, 128 children (733 surfaces) presented complete baseline data and had included primary teeth to be reassessed. Approximately 9% of the reassessed surfaces showed caries progression. Among the univariate models created with each one of these variables, the model containing the surface integrity as a predictor had the lowest AIC (364.5). Univariate predictive models tended to present better goodness-of-fit (AICs < 388) and discrimination (C:0.959–0.966) than those combining parameters (AIC:365–393, C:0.958–0.961). When only non-cavitated surfaces were considered, roughness compounded the model that better predicted the lesions' progression (AIC = 217.7, C:0.91). Conclusions Univariate model fitted considering the presence of cavitation show the best predictive goodness-of-fit and discrimination. For non-cavitated lesions, the simplest way to predict those lesions that tend to progress is by assessing enamel roughness. In general, the evaluation of other conjoint parameters seems unnecessary for all non-frankly cavitated lesions.

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

Cited by 9 publications

References 27 publications

Comparison between the rotary (Hyflex EDM®) and manual (k-file) technique for instrumentation of primary molars: a 12-month randomized clinical follow-up study

Comparison between the rotary (Hyflex EDM®) and manual (k-file) technique for instrumentation of primary molars: a 12-month randomized clinical follow-up study

Influence of two caries detection strategies on the quality of life of preschool children: An analysis of secondary outcomes of a 2‐Year randomized clinical trial

How combining different caries lesions characteristics may be helpful in short-term caries progression prediction: model development on occlusal surfaces of primary teeth

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