TY - JOUR

T1 - The effect of two clinical criteria in the assessment of caries lesions around restorations in children (CARDEC-03)

T2 - study protocol for a diagnostic randomized clinical trial

AU - Moro, Bruna Lorena Pereira

AU - Signori, Cácia

AU - Freitas, Raiza Dias

AU - Pontes, Laura Regina Antunes

AU - Lenzi, Tathiane Larissa

AU - Tedesco, Tamara Kerber

AU - Raggio, Daniela Prócida

AU - Braga, Mariana Minatel

AU - Ekstrand, Kim Rud

AU - Cenci, Maximiliano Sérgio

AU - CARDEC collaborative group, CaCIA collaborative group

PY - 2021

Y1 - 2021

N2 - 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.

AB - 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.

KW - Dental Caries

KW - Dental Restoration Repair

KW - Diagnosis

KW - Pediatric Dentistry

KW - Permanent Dental Restoration

KW - Randomized Controlled Trial

U2 - 10.12688/f1000research.23801.3

DO - 10.12688/f1000research.23801.3

M3 - Journal article

C2 - 33520191

AN - SCOPUS:85100716252

VL - 9

JO - F1000Research

JF - F1000Research

SN - 2046-1402

M1 - 650

ER -