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

Raíza Dias Freitas, Bruna Lorena Pereira Moro, Laura Regina Antunes Pontes, Haline Cunha Medeiros Maia, Ana Laura Passaro, Rodolfo Carvalho Oliveira, Jonathan Rafael Garbim, Maria Eduarda Franco Vigano, Tamara Kerber Tedesco, Christopher Deery, Daniela Prócida Raggio, Maximiliano Sergio Cenci, Fausto Medeiros Mendes, Mariana Minatel Braga, CARDEC collaborative group - CARDEC-03 trial, Ana Laura Passaro, Annelry Costa Serra, Antonio Carlos Lopes Silva, Bruna Lorena Pereira Moro, Carolina de Picoli Acosta, Caroline Mariano Laux, Cíntia Saori Saihara, Daniela Prócida Raggio, Fausto Medeiros Mendes, Haline Cunha Medeiros Maia, Isabel Cristina Olegário da Costa, Isabella Ronqui de Almeida, Jhandira Daibelis Yampa Vargas, Jonathan Rafael Garbim, José Carlos P Imparato, Julia Gomes Freitas, Karina Haibara De Natal, Laura Regina Antunes Pontes, Mariana Bifulco, Mariana Minatel Braga, Mariana Pinheiro de Araújo, Mayume Amorim do Vale, Raiza Dias Freitas, Renata Marques Samuel, Rita Baronti, Rodolfo de Carvalho Oliveira, Simone Cesar, Tatiane Fernandes Novaes, Tamara Kerber Tedesco, Thais Gimenez, Tathiane Larissa Lenzi, Cacia Signori, Maximiliano Sérgio Cenci, Kim Rud Ekstrand, Raíza Dias Freitas, Bruna Lorena Pereira Moro, Laura Regina Antunes Pontes, Haline Cunha Medeiros Maia, Ana Laura Passaro, Rodolfo Carvalho Oliveira, Jonathan Rafael Garbim, Maria Eduarda Franco Vigano, Tamara Kerber Tedesco, Christopher Deery, Daniela Prócida Raggio, Maximiliano Sergio Cenci, Fausto Medeiros Mendes, Mariana Minatel Braga, CARDEC collaborative group - CARDEC-03 trial, Ana Laura Passaro, Annelry Costa Serra, Antonio Carlos Lopes Silva, Bruna Lorena Pereira Moro, Carolina de Picoli Acosta, Caroline Mariano Laux, Cíntia Saori Saihara, Daniela Prócida Raggio, Fausto Medeiros Mendes, Haline Cunha Medeiros Maia, Isabel Cristina Olegário da Costa, Isabella Ronqui de Almeida, Jhandira Daibelis Yampa Vargas, Jonathan Rafael Garbim, José Carlos P Imparato, Julia Gomes Freitas, Karina Haibara De Natal, Laura Regina Antunes Pontes, Mariana Bifulco, Mariana Minatel Braga, Mariana Pinheiro de Araújo, Mayume Amorim do Vale, Raiza Dias Freitas, Renata Marques Samuel, Rita Baronti, Rodolfo de Carvalho Oliveira, Simone Cesar, Tatiane Fernandes Novaes, Tamara Kerber Tedesco, Thais Gimenez, Tathiane Larissa Lenzi, Cacia Signori, Maximiliano Sérgio Cenci, Kim Rud Ekstrand

Abstract

Background: Different approaches have been used by dentists to base their decision. Among them, there are the aesthetical issues that may lead to more interventionist approaches. 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 approaches 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 and extrapolating these findings to a longer time horizon.

Methods: A trial-based economic evaluation will be conducted, including three cost-effectiveness analyses (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 2 years, and we will adopt the societal perspective. The average costs per child for 24 months will be calculated. Three different cost-effectiveness analyses (CEA) will be performed. For CEAs, the effects will be the number of operative interventions (primary CEA analysis), the time to these new interventions, the percentage of patients who did not need new interventions in the follow-up, and changes in children's oral health-related quality of life (secondary analyses). For CUA, the effect will be tooth-related 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 and probabilistic sensitivity analyses to handle uncertainties. The net benefit will be calculated, and acceptability curves plotted using different willingness-to-pay thresholds. Using Markov models, a longer-term economic evaluation will be carried out with trial results extrapolated over a primary tooth lifetime horizon.

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 2 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, these trial-based economic evaluations may bring actual evidence of the economic impact of such interventions.

Trial registration: NCT03520309 . Registered May 9, 2018. Economic evaluations (the focus of this plan) are not initiated at the moment.

Keywords: Cost-effectiveness analysis; Cost-utility analysis; Dental caries.

Conflict of interest statement

The authors declare they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
The Standard Gamble experiment to be performed with parents assessing three health states related to dental caries in their child’s primary molars

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