Randomized clinical trial to evaluate two methods of caries risk assessment in schoolchildren: the CARDEC-PEL 04 study protocol

Aryane Marques Menegaz, Thays Torres do Vale Oliveira, Mariana Minatel Braga, Daniela Prócida Raggio, Maximiliano Sergio Cenci, Fausto Medeiros Mendes, Marina Sousa Azevedo, Aryane Marques Menegaz, Thays Torres do Vale Oliveira, Mariana Minatel Braga, Daniela Prócida Raggio, Maximiliano Sergio Cenci, Fausto Medeiros Mendes, Marina Sousa Azevedo

Abstract

Background: Caries risk assessment is an essential element for managing and preventing dental caries in children. Individual caries risk assessment can be conducted to evaluate the presence or absence of single factors, or using multivariate models, a combination of factors. The subject has been extensively studied, but no previous research has compared whether a more elaborate and individualized method of caries risk benefits the patient than more straightforward strategies. Thus, this protocol evaluates the efficacy of two risk assessment methods for caries control in children, a simplified method based on caries experience evaluation and a multivariate method described in the literature.

Methods: This is a randomized, double-blind, controlled, parallel-treatment trial protocol. Two groups will be tested for two forms of caries risk assessment: an individualized and detailed multivariate method based on the guidelines of the Caries Care International 4D and another simplified process, based only on caries experience in primary and/or permanent dentition, considering the presence of decayed, missing and filled teeth using the DMFT/dmft index. Participants will be children aged 8 to 11 years, followed up at 12 and 24 months. The primary outcome will be a composite outcome representing the number of tooth surfaces requiring operative intervention (account variable). In addition, the Shapiro-Wilk normality test and Student's t-test will be performed. A multivariate analysis using negative binomial regression will compare groups in the intention-to-treat population, considering a two-tailed significance level of 5%.

Discussion: This is the first randomized clinical trial aiming to compare dental caries-related treatment and follow-up based on a detailed, multivariate and individualized assessment of caries risk in school-age children to a simpler risk assessment strategy based on caries experience. This study will define whether there are essential benefits to the patient that justify the choice of one method over the other. Trial registration Clinicaltrials.gov registration: NCT03969628. Registered on May 31th, 2019.

Keywords: Children; Dental caries; Randomized clinical trial; Risk assessment.

Conflict of interest statement

The authors declares that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Classification of caries risk according to the criteria
Fig. 2
Fig. 2
Simplified and multivariate caries risk assessment criteria
Fig. 3
Fig. 3
Caries risk guide and clinical management
Fig. 4
Fig. 4
Standard protocol items timeline, enrolment, registration, feedback, and evaluations

References

    1. Pitts N, Baez R, Diaz-Guallory C, et al. Early childhood caries. IAPD Bangkok declaration. Int J Paediatr Dent. 2019;29(3):384–386. doi: 10.1111/ipd.12490.
    1. Gimenez T, Bispo BA, Souza DP, Viganó ME, Wanderley MT, Mendes FM, et al. Does the decline in caries prevalence of Latin American and Caribbean children continue in the new century? Evidence from systematic review with meta-analysis. PLoS ONE. 2016;11(10):1–14. doi: 10.1371/journal.pone.0164903.
    1. Petersen PE. The World Oral Health Report 2003: continuous improvement of oral health in the 21st century—the approach of the WHO Global Oral Health Programme. Community Dent Oral Epidemiol. 2003;31(Suppl. 1):3–24. doi: 10.1046/j..2003.com122.x.
    1. Ismail AI, Pitts NB, Tellez M, Banerjee A, Deery C, Douglas G, et al. The International caries classification and management system (ICCMSTM) an example of a caries management pathway. BMC Oral Health. 2015;15(1):S9. doi: 10.1186/1472-6831-15-S1-S9.
    1. Twetman S, Fontana M, Featherstone JDB. Risk assessment—can we achieve consensus? Community Dent Oral Epidemiol. 2013;41(1):64–70. doi: 10.1111/cdoe.12026.
    1. Twetman S. Caries risk assessment in children: how accurate are we? Eur Arch Paediatr Dent. 2016;17(1):27–32. doi: 10.1007/s40368-015-0195-7.
    1. Kühnisch J, Ekstrand KR, Pretty I, Twetman S, van Loveren C, Gizani S, et al. Best clinical practice guidance for management of early caries lesions in children and young adults: an EAPD policy document. Eur Arch Paediatr Dent. 2016;17(1):3–12. doi: 10.1007/s40368-015-0218-4.
    1. Mejàre I, Axelsson S, Dahlén G, Espelid I, Norlund A, Tranæus S, et al. Caries risk assessment. A systematic review. Acta Odontol Scand. 2014;72(2):81–91. doi: 10.3109/00016357.2013.822548.
    1. Leong PM, Gussy MG, Barrow SYL, De Silva-Sanigorski A, Waters E. A systematic review of risk factors during first year of life for early childhood caries. Int J Paediatr Dent. 2013;23(4):235–250. doi: 10.1111/j.1365-263X.2012.01260.x.
    1. Senneby A, Mejàre I, Sahlin NE, Svensäter G, Rohlin M. Diagnostic accuracy of different caries risk assessment methods. A systematic review. J Dent. 2015;43(12):1385–1393. doi: 10.1016/j.jdent.2015.10.011.
    1. Tellez M, Gomez J, Pretty I, Ellwood R, Ismail A. Evidence on existing caries risk assessment systems: are they predictive of future caries? Community Dent Oral Epidemiol. 2013;41(1):67–78. doi: 10.1111/cdoe.12003.
    1. Hall-Scullin E, Whitehead H, Milsom K, Tickle M, Su TL, Walsh T. Longitudinal study of caries development from childhood to adolescence. J Dent Res. 2017;96(7):762–767. doi: 10.1177/0022034517696457.
    1. Fontana M, Zero DT. Assessing patients’ caries risk. J Am Dent Assoc. 2006;137(9):1231–1239. doi: 10.14219/jada.archive.2006.0380.
    1. Divaris K. Predicting dental caries outcomes in children. J Dent Res. 2016;95(3):248–254. doi: 10.1177/0022034515620779.
    1. Pitts NB, Ismail AI, Martignon S, Ekstrand K, Douglas GVV, Longbottom C. ICCMSTM Guide for Practitioners and Educators. ICCMSTM Resour. 2014;1–84.
    1. Martignon S, Pitts NB, Goffiin G, Mazevet M, Douglas GVA, Newton JT. CariesCare practice guide: consensus on evidence into practice. Br Dent J. 2019;227(5):353–362. doi: 10.1038/s41415-019-0678-8.
    1. Cademartori MG, Da Rosa DP, Oliveira LJC, Corrêa MB, Goettems ML. Validity of the Brazilian version of the Venham’s behavior rating scale. Int J Paediatr Dent. 2017;27(2):120–127. doi: 10.1111/ipd.12231.
    1. World Health Organization . Basic epidemiological survey of oral health. 4a. World Health Organization; 1997.
    1. Pitts NB, Ekstrand K. International caries detection and assessment system (ICDAS) and its international caries classification and management system (ICCMS)—methods for staging of the caries process and enabling dentists to manage caries. Community Dent Oral Epidemiol. 2013;41(1):41–52. doi: 10.1111/cdoe.12025.
    1. Guedes DP, Guedes JERP. Translation, cross-cultural adaptation and psychometric properties of the KIDSCREEN-52 for the Brazilian population. Rev Paul Pediatr. 2011;29(3):364–371. doi: 10.1590/S0103-05822011000300010.
    1. Martins MT, Ferreira FM, Oliveira AC, Paiva SM, Vale MP, Allison PJ, et al. Preliminary validation of the Brazilian version of the Child Perceptions Questionnaire 8–10. Eur J Paediatr Dent. 2009;10(3):135–140.
    1. Weinstein P, Spiekerman C, Milgrom P. Randomized equivalence trial of intensive and semiannual applications of fluoride varnish in the primary dentition. Caries Res. 2009;43(6):484–490. doi: 10.1159/000264686.
    1. Qvist V, Poulsen A, Teglers PT, Mjör IA. The longevity of different restorations in primary teeth. Int J Paediatr Dent. 2010;20(1):1–7. doi: 10.1111/j.1365-263X.2009.01017.x.
    1. Tickle M, Blinkhorn AS, Milsom KM. The occurrence of dental pain and extractions over a 3-year period in a cohort of children aged 3–6 years. J Public Health Dent. 2008;68(2):63–69. doi: 10.1111/j.1752-7325.2007.00048.x.

Source: PubMed

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

3
Abonnere