Efficacy of conventional treatment with composite resin and atraumatic restorative treatment in posterior primary teeth: study protocol for a randomised controlled trial

Nathalia Miranda Ladewig, Cíntia Saori Sahiara, Laysa Yoshioka, Isabel Cristina Olegário, Isabela Floriano, Tamara Kerber Tedesco, Fausto Medeiros Mendes, Mariana Minatel Braga, Daniela Procida Raggio, Nathalia Miranda Ladewig, Cíntia Saori Sahiara, Laysa Yoshioka, Isabel Cristina Olegário, Isabela Floriano, Tamara Kerber Tedesco, Fausto Medeiros Mendes, Mariana Minatel Braga, Daniela Procida Raggio

Abstract

Introduction: Despite the widespread acceptance of conventional treatment using composite resin in primary teeth, there is limited evidence that this approach is the best option in paediatric clinics. Atraumatic restorative treatment (ART) using high-viscosity glass ionomer cement has gradually become more popular because it performs well in clinical studies, is easy to handle and is patient friendly. Therefore, the aim of this randomised clinical trial study is to compare the restoration longevity of conventional treatment using composite resin with that of ART in posterior primary teeth. As secondary outcomes, cost-efficacy and patient self-reported discomfort will also be tested.

Methods and analysis: Children aged 3-6 years presenting with at least one occlusal and/or occlusal-proximal cavity will be randomly assigned to one of two groups according to the dental treatment: ART (experimental group) or composite resin restoration (control group). The dental treatment will be performed at a dental care trailer located in an educational complex in Barueri/SP, Brazil. The unit of randomisation will be the child. A sample size of 240 teeth with occlusal cavities and 188 teeth with occlusal-proximal cavities has been calculated. The primary outcome will be restoration longevity, which will be clinically assessed after 6, 12, 18 and 24 months by two examiners. The duration of the dental treatment and the cost of all materials used will be considered when estimating the cost-efficacy of each treatment. Individual discomfort will be measured after each dental procedure using the Facial Scale of Wong-Baker.

Ethics and dissemination: This clinical trial was approved by the local ethics committee from the Faculty of Dentistry of the University of São Paulo (registration no. 1.556.018). Participants will be included after their legal guardians have signed an informed consent form containing detailed information about the research.

Trial registration number: www.clinicaltrials.gov, NCT02562456; Pre-results.

Keywords: health economics; oral medicine; paediatrics.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Clinical trial's timeline.
Figure 2
Figure 2
Diagram of total cost calculation.

References

    1. Dhar V, Hsu KL, Coll JA, et al. . Evidence-based update of pediatric dental restorative procedures: dental materials. J Clin Pediatr Dent 2015;39:303–10. 10.17796/1053-4628-39.4.303
    1. Casagrande L, Dalpian DM, Ardenghi TM, et al. . Randomized clinical trial of adhesive restorations in primary molars. 18-month results. Am J Dent 2013;26:351–5.
    1. Yengopal V, Harneker SY, Patel N, et al. . Dental fillings for the treatment of caries in the primary dentition. Cochrane Database Syst Rev 2009:CD004483 10.1002/14651858.CD004483.pub2
    1. Mickenautsch S, Yengopal V, Banerjee A. Atraumatic restorative treatment versus amalgam restoration longevity: a systematic review. Clin Oral Investig 2010;14:233–40. 10.1007/s00784-009-0335-8
    1. Raggio DP, Hesse D, Lenzi TL, et al. . Is atraumatic restorative treatment an option for restoring occlusoproximal caries lesions in primary teeth? A systematic review and meta-analysis. Int J Paediatr Dent 2013;23:435–43. 10.1111/ipd.12013
    1. Qvist V, Poulsen A, Teglers PT, et al. . The longevity of different restorations in primary teeth. Int J Paediatr Dent 2010;20:1–7. 10.1111/j.1365-263X.2009.01017.x
    1. Heintze SD, Rousson V. Clinical effectiveness of direct class II restorations—a meta-analysis. J Adhes Dent 2012;14:407–31. 10.3290/j.jad.a28390
    1. Schriks MC, van Amerongen WE. Atraumatic perspectives of ART: psychological and physiological aspects of treatment with and without rotary instruments. Community Dent Oral Epidemiol 2003;31:15–20. 10.1034/j.1600-0528.2003.00021.x
    1. Frencken JE, Pilot T, Songpaisan Y, et al. . Atraumatic Restorative Treatment (ART): rationale, technique, and development. J Public Health Dent 1996;56:135–40. 10.1111/j.1752-7325.1996.tb02423.x
    1. Frencken JE. The state-of-the-art of ART restorations. Dent Update 2014;41:218–20.
    1. van 't Hof MA, Frencken JE, van Palenstein Helderman WH, et al. . The atraumatic restorative treatment (ART) approach for managing dental caries: a meta-analysis. Int Dent J 2006;56:345–51. 10.1111/j.1875-595X.2006.tb00339.x
    1. van Dijken JW, Pallesen U. Long-term dentin retention of etch-and-rinse and self-etch adhesives and a resin-modified glass ionomer cement in non-carious cervical lesions. Dent Mater 2008;24:915–22. 10.1016/j.dental.2007.11.008
    1. Fuks AB, Araujo FB, Osorio LB, et al. . Clinical and radiographic assessment of class II esthetic restorations in primary molars. Pediatr Dent 2000;22:479–85.
    1. Ersin NK, Candan U, Aykut A, et al. . A clinical evaluation of resin-based composite and glass ionomer cement restorations placed in primary teeth using the ART approach: results at 24 months. J Am Dent Assoc 2006;137:1529–36. 10.14219/jada.archive.2006.0087
    1. Alves dos Santos MP, Luiz RR, Maia LC. Randomised trial of resin-based restorations in class I and class II beveled preparations in primary molars: 48-month results. J Dent 2010;38:451–9. 10.1016/j.jdent.2010.02.004
    1. Novaes TF, Matos R, Raggio DP, et al. . Children's discomfort in assessments using different methods for approximal caries detection. Braz Oral Res 2012;26:93–9. 10.1590/S1806-83242012000200002
    1. Staman NM, Townsend JA, Hagan JL, et al. . Observational study: discomfort following dental procedures for children. Pediatr Dent 2013;35:52–4.
    1. da Mata C, Allen PF, Cronin M, et al. . Cost-effectiveness of ART restorations in elderly adults: a randomized clinical trial. Community Dent Oral Epidemiol 2014;42:79–87. 10.1111/cdoe.12066
    1. Mickenautsch S, Munshi I, Grossman ES, et al. . Comparative cost of ART and conventional treatment within a dental school clinic. SADJ 2002;57:135–45.
    1. WHO(World Health Organization). Oral health surveys: basic methods. 3 ed Geneva: World Health Organization, 1997.
    1. Saúde BMda. Projeto SB Brasil 2010: condições de saúde bucal da população brasileira 2009-2010. Brasília: Resultados principais, 2012.
    1. Frencken JE, Pilot T, Songpaisan Y, et al. . Atraumatic restorative treatment (ART): rationale, technique, and development. J Public Health Dent 1996;56:135–40. 10.1111/j.1752-7325.1996.tb02423.x
    1. Gibson G, Jurasic MM, Wehler CJ, et al. . Supplemental fluoride use for moderate and high caries risk adults: a systematic review. J Public Health Dent 2011;71:no–84. 10.1111/j.1752-7325.2011.00261.x
    1. Cerqueira DF, Mello-Moura AC, Santos EM, et al. . Cytotoxicity, histopathological, microbiological and clinical aspects of an endodontic iodoform-based paste used in pediatric dentistry: a review. J Clin Pediatr Dent 2008;32:105–10. 10.17796/jcpd.32.2.k1wx5571h2w85430
    1. Walsh T, Worthington HV, Glenny AM, et al. . Fluoride toothpastes of different concentrations for preventing dental caries in children and adolescents. Cochrane Database Systematic Review 2010;20:1–221.
    1. Frencken JE, Holmgren CF. Tratamento restaurador atraumático (ART) para a cárie dentária. São Paulo: Santos, 2001.
    1. Roeleveld AC, van Amerongen WE, Mandari GJ. Influence of residual caries and cervical gaps on the survival rate of class II glass ionomer restorations. Eur Arch Paediatr Dent 2006;7:85–90. 10.1007/BF03320820
    1. Takanashi Y, Penrod JR, Lund JP, et al. . A cost comparison of mandibular two-implant overdenture and conventional denture treatment. Int J Prosthodont 2004;17:199–6. 10.1016/j.prosdent.2004.06.016
    1. Oscarson N, Källestål C, Fjelddahl A, et al. . Cost-effectiveness of different caries preventive measures in a high-risk population of Swedish adolescents. Community Dent Oral Epidemiol 2003;31:169–78. 10.1034/j.1600-0528.2003.00033.x
    1. Floriano I, Gimenez R, Reyes A, et al. . Análise de custos de diferentes abordagens para avaliação de lesões de cárie em dentes decíduos. Brazilian Oral Research 2013;27:41–9.
    1. Morita MC, Haddad AE, Araújo ME. Perfil atual e tendências do cirurgião-dentista brasileiro. Maringá: Dental Press Internacional, 2010.
    1. Kawai Y, Murakami H, Takanashi Y, et al. . Efficient resource use in simplified complete denture fabrication. J Prosthodont 2010;19:512–6. 10.1111/j.1532-849X.2010.00628.x
    1. Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs 1988;14:9–17.
    1. Novaes TF, Matos R, Raggio DP, et al. . Influence of the discomfort reported by children on the performance of approximal caries detection methods. Caries Res 2010;44:465–71. 10.1159/000320266

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