The effect of two clinical criteria in the assessment of caries lesions around restorations in children (CARDEC-03): study protocol for a diagnostic randomized clinical trial

Moro, Bruna Lorena Pereira; Signori, Cácia; Freitas, Roseli Santos de; Pontes, Laura Regina Antunes; Lenzi, Tathiane Larissa; Tedesco, Tamara Kerber; Raggio, Daniela Prócida; Braga, Mariana Minatel; Ekstrand, Kim R.; Cenci, Maximiliano Sérgio; Mendes, Fausto Medeiros

doi:10.12688/f1000research.23801.3

Cited by 5 publications

(13 citation statements)

References 36 publications

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“…This examiner reached intra-examiner and inter-examiner weighted kappa values greater than 0.75 for both FDI and CARS criteria previously the beginning of the study. Detailed information regarding the examiner training and calibration can be assessed in the clinical trial study protocol [Moro et al, 2020a]. The same examiner performed both methods in all included teeth.…”

Section: Caries Lesion Detection Methodsmentioning

confidence: 99%

“…3 (CARDEC-3), is registered at the platform Clinicaltrials.gov (NCT03520309). In addition, the CARDEC-3 protocol is published elsewhere and contains more information about the clinical trial [Moro et al, 2020a]. Another paper based on this study was published to observe the influence of different diagnostic strategies on the treatment decision for caries around restorations [Moro et al, 2020b].…”

Section: Study Design and Ethical Aspectsmentioning

confidence: 99%

“…The sample size calculation was based on the primary outcome of the randomized clinical trial [Moro et al, 2020a], which was the percentage of restorations requiring reintervention. For the main clinical trial, the minimum sample size was 626 restored primary teeth.…”

Section: Participant Selection and Sample Sizementioning

confidence: 99%

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Clinical Accuracy of Two Different Criteria for the Detection of Caries Lesions around Restorations in Primary Teeth

et al. 2022

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This is a delayed-type cross-sectional prospective accuracy study nested in a randomized clinical trial. The aim was to investigate the diagnostic accuracy of two visual criteria for caries lesions detection around restorations in primary teeth: the International Dental Federation (FDI) criteria, considering adaptation, staining and presence of caries, and the Caries Associated with Restorations and Sealants (CARS) system. For this, one examiner made the diagnosis and subsequent treatment decision using visual assessment in 163 children (3 to 10 years old) with both FDI and CARS criteria. The order of criteria used was defined by randomization. The reference standard was composed of two approaches: (i) presence of carious tissue after restoration removal or (ii) presence of caries lesions after six and 12 months of follow-up. Sensitivity, specificity, and accuracy parameters were calculated at the dentin threshold. Poisson multilevel regression analyses were performed to evaluate the association of the diagnostic methods and other explanatory variables with the outcomes. Of the 651 restorations included, 480 were evaluated by the reference standard methods and were analyzed. The CARS system presented higher accuracy (0.721) than those obtained with FDI recurrence of caries (0.702), FDI marginal adaptation (0.700) and FDI marginal staining criteria (0.681). The FDI marginal staining showed the study’s lowest sensitivity (0.280) and accuracy (0.681) values. The specificity values of FDI recurrence of caries and FDI marginal adaptation were lower than the CARS system. Restorations assessed after the follow-up period resulted in lower sensitivity but higher specificity than those replaced after initial evaluation. In conclusion, the CARS system is more accurate in detecting caries around restorations in primary teeth than the FDI system, in general. However, the FDI recurrence of caries and FDI marginal adaptation present similar performance to the CARS system when the dentin threshold is considered. On the other hand, marginal staining is not an accurate parameter to evaluate caries around restorations.

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Section: Caries Lesion Detection Methodsmentioning

confidence: 99%

Section: Study Design and Ethical Aspectsmentioning

confidence: 99%

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Clinical Accuracy of Two Different Criteria for the Detection of Caries Lesions around Restorations in Primary Teeth

et al. 2022

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“…The CARDEC-03 trial is a two-arm, parallel-group, patient-randomized controlled trial aiming to assess which of the two diagnostic strategies (based on FDI criteria or CARS) leads to less new interventions in restored primary teeth during two years of follow-up. Further details regarding the trial have been published in the study protocol [7].…”

Section: Methodsmentioning

confidence: 99%

“…To date, there is no consensus on the best strategy to adopt in clinical practice, and most studies do not explore the clinical relevance of the accuracy tests nor patient-centered outcomes [2]. An ongoing clinical trial (CARies DEtection in Children -CARDEC-03) aims to assess the impact of using the FDI and CARS criteria in the assessment of restorations in primary teeth [7]. At rst glance, when using a more interventionist strategy (using the FDI criteria), the indication of replacements of restorations in the baseline was more frequent than using the strategy based on CARS [8].…”

Section: Introductionmentioning

confidence: 99%

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

Freitas

Moro

Pontes

et al. 2021

Preprint

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Background Different approaches have been used in the clinical routine to assess restorations and determine the need for further reinterventions. In general, dentists based their decision in different parameters, including aesthetical ones, leading to a more interventionist approach. 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 strategies 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. Methods A trial-based economic evaluation will be conducted, including three cost-effectiveness analysis (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 two years, and we will adopt the societal perspective. The average costs per child for 24 months will be calculated. Three different cost-effectiveness analysis (CEA) will be performed. For CEAs, the effects will be the number of operative interventions, the percentage of patients who did not need new interventions in the follow-up, and the scores obtained with a questionnaire to assess children’s oral health-related quality of life. For CUA, the effect will be 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 one-way and probabilistic sensitivity analyses to handle uncertainties. The net benefit will be calculated, and acceptability curves plotted using different willingness-to-pay thresholds. A longer-term economic evaluation will be carried out with trial results extrapolated over a primary tooth lifetime horizon using Markov modelling methods. 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 two 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, this trial-based economic evaluations may bring actual evidence of the economic impact of such these interventions. Trial registration: NCT03520309. Registered May 9th, 2018. Economic evaluations (the focus of this plan) are not initiated at the moment.

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Comparing modified USPHS and FDI criteria for the assessment of glass ionomer restorations in primary molars utilising clinical and photographic evaluation

Larasati,

Rizal,

Fauziah

2024

Eur Arch Paediatr Dent

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The effect of two clinical criteria in the assessment of caries lesions around restorations in children (CARDEC-03): study protocol for a diagnostic randomized clinical trial

Cited by 5 publications

References 36 publications

Clinical Accuracy of Two Different Criteria for the Detection of Caries Lesions around Restorations in Primary Teeth

Clinical Accuracy of Two Different Criteria for the Detection of Caries Lesions around Restorations in Primary Teeth

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

Comparing modified USPHS and FDI criteria for the assessment of glass ionomer restorations in primary molars utilising clinical and photographic evaluation

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