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

Pereira Moro, Bruna Lorena, Signori, Cacia, Reitas, Raiza Dias, Antunes Pontes, Laura Regina, Lanzi, Tathiane Larissa, Tedesco, Tamara Kerber, Raggio, Daniela Procida ORCID: https://orcid.org/0000-0002-0048-2068, Braga, Mariana Minatel, Ekstrand, Kim Rud, Cemci, Maximiliano Sergio, Mendes, Fausto Medeiros, CARDEC Collaborative Group and CaCIA Collaborative Group 2021. 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. F1000Research 9 , 650. 10.12688/f1000research.23801.3

PDF - Published Version Available under License Creative Commons Attribution. Download (3MB)

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.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Dentistry
Publisher:	F1000Research
ISSN:	2046-1402
Date of First Compliant Deposit:	30 March 2022
Last Modified:	03 May 2023 00:07
URI:	https://orca.cardiff.ac.uk/id/eprint/148761

Citation Data

Cited 1 time in Scopus. View in Scopus. Powered By Scopus® Data

Actions (repository staff only)

Edit Item