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

Bruna Lorena Pereira Moro, Cácia Signori, Raiza Dias Freitas, Laura Regina Antunes Pontes, Tathiane Larissa Lenzi, Tamara Kerber Tedesco, Daniela Prócida Raggio, Mariana Minatel Braga, Kim Rud Ekstrand, Maximiliano Sérgio Cenci, Fausto Medeiros Mendes, CARDEC collaborative group, CaCIA collaborative group, Bruna Lorena Pereira Moro, Cácia Signori, Raiza Dias Freitas, Laura Regina Antunes Pontes, Tathiane Larissa Lenzi, Tamara Kerber Tedesco, Daniela Prócida Raggio, Mariana Minatel Braga, Kim Rud Ekstrand, Maximiliano Sérgio Cenci, Fausto Medeiros Mendes, CARDEC collaborative group, CaCIA collaborative group

Abstract

Introduction: The detection of caries lesions around restoration can be challenging. Therefore, the use of some criteria has been proposed in order to give more objectivity to the diagnosis process. Two of them are the International Dental Federation (FDI) and the Caries Associated with Restorations and Sealants (CARS) criteria. Both methods have a different approach to caries, and it is not possible to know which one of them is the best to use in clinical practice to assess restorations in children. Thus, the present protocol aims to evaluate the effect of the use of the FDI and CARS criteria in the assessment of caries lesions around restorations in primary teeth on outcomes related to oral health in children and costs resulting from the assessments. Methods and analysis: A total of 626 restorations of children from three to 10 years were randomly assessed and are being treated following the FDI criteria (FDI group) or CARS criteria (CARS group). Participants will be followed-up after six, 12, 18, and 24 months. The primary outcome will be the need for a new intervention in the evaluated restorations. This outcome consists of several components, and each of these events will be analyzed separately as secondary outcomes. The changes in children's oral health-related quality of life and the cost of the restoration dental treatments will also be analyzed as secondary outcomes. The methods will be compared using the Cox regression model with shared frailty. A significance level of 5% will be adopted for all statistical analyses. Discussion: This will be the first randomized clinical study carried out regarding the detection of caries lesions around restorations in primary teeth. Trial registration: The study underwent registration in Clinicaltrials.gov ( NCT03520309) on 9 May 2018.

Keywords: Dental Caries; Dental Restoration Repair; Diagnosis; Pediatric Dentistry; Permanent Dental Restoration; Randomized Controlled Trial.

Conflict of interest statement

No competing interests were disclosed.

Copyright: © 2021 Moro BLP et al.

Figures

Figure 1.. Patient’s plan decision flowchart based…
Figure 1.. Patient’s plan decision flowchart based on the International Dental Federation (FDI) criteria.
Figure 2.. Patient’s plan decision flowchart based…
Figure 2.. Patient’s plan decision flowchart based on the Caries Associated with Restoration and Sealants (CARS) criteria.
Figure 3.. Clinical example of the restoration…
Figure 3.. Clinical example of the restoration assessment performed in a primary posterior tooth according to the FDI and CARS criteria.
Figure 4.. Patient’s plan decision flowchart based…
Figure 4.. Patient’s plan decision flowchart based on the International Caries Detection and Assessment System (ICDAS) criteria.
Figure 5.. Clinical trial's timeline.
Figure 5.. Clinical trial's timeline.
ECOHIS, Early Childhood Oral Health Impact Scale; FDI, International Dental Federation; CARS, Caries Associated with Restorations and Sealants.

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