Impact of different restorative treatments for deep caries lesion in primary teeth (CEPECO 1) - study protocol for a noninferiority randomized clinical trial

Gabriela Seabra Quennehen da Silva, Daniela Prócida Raggio, Gabriela Fernanda Ribeiro Machado, Anna Carolina Volpi Mello-Moura, Thais Gimenez, Isabela Floriano, Tamara Kerber Tedesco, Gabriela Seabra Quennehen da Silva, Daniela Prócida Raggio, Gabriela Fernanda Ribeiro Machado, Anna Carolina Volpi Mello-Moura, Thais Gimenez, Isabela Floriano, Tamara Kerber Tedesco

Abstract

Background: Due to the lack of evidence to determine the best treatment for deep cavitated caries lesions in primary molars, the search for an effective restorative technique, which results in a minimal discomfort to patients, and reduce the time needed for the treatment, becomes relevant. The objective of this randomized clinical trial was to evaluate if high-viscosity glass ionomer cement (HVGIC) restorations is noninferior to restoration with calcium hydroxide cement associated with HVGIC for treatment of deep lesions in primary molars, as well as the impact of the treatments on cost and discomfort of the patient.

Methods: A non-inferiority randomized clinical trial with two parallels arms (1:1) will be conducted. Children with 4 to 8 years will be selected at Clinic of Pediatric Dentistry at Ibirapuera University. 108 teeth will be randomized into two groups: (1) Calcium hydroxide cement associated with HVGIC and (2) HVGIC restoration. Primary outcome will be considered the pulp vitality and to be evaluated after 6, 12, 18 and 24 months by two calibrated examiners. Survival of restorations will also be evaluated in the equal intervals. The duration of dentals treatment and the cost of all materials used will be considered for estimating of cost-efficacy of each treatment. Individual discomfort will be measured after each dental procedure using the Wong-Baker's Facial Scale. For the primary outcome, Kaplan-Meier survival and the long-rank test will be used to comparison between the groups. Cox regression will be performed to assess the influence of variables on the outcome. For all analyzes, the significance level is set at 5%.

Discussion: Based on the philosophy of ART, our hypothesis is that the HVGIC restoration is a possible approach to restore the deep caries lesion with pulp vitality without the use of rubber dam and anesthesia.

Trial registration: Clinicaltrials.gov registration NCT02903979 . Registered on June 9th 2016.

Keywords: Dental caries; Pediatric dentistry; Primary teeth.

Conflict of interest statement

Ethics approval and consent to participate

This clinical trial was approved by the local ethical board committee from the Faculty of Dentistry of the University Ibirapuera (registration no. 1.670.059). Participants will be included after their legal guardians have signed an informed consent form containing detailed information about the research and the children nod their participation.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow diagram of clinical trial’s phases
Fig. 2
Fig. 2
Organization chart of decision-making process of teeth not included in the trial

References

    1. Auad SM, Waterhouse PJ, Nunn JH, Moynihan PJ. Dental caries and its association with sociodemographics, erosion, and diet in schoolchildren from Southeast Brazil. Pediatr Dent. 2009;3:229–235.
    1. Bönecker M, Ardenghi TM, Oliveira LB, Sheiham A, Marcenes W. Trends in dental caries in 1- to 4-year-old children in a Brazilian city between 1997 and 2008. Int J Paediatr Dent. 2010;20:125–131. doi: 10.1111/j.1365-263X.2009.01030.x.
    1. Abanto J, Tsakos G, Paiva SM, Carvalho TS, Raggio DP, Bönecker M. Impact of dental caries and trauma on quality of life among 5- to 6-year-old children: perceptions of parents and children. Community Dent Oral Epidemiol. 2014;42:385–394. doi: 10.1111/cdoe.12099.
    1. Gradella CM, Bernabé E, Bönecker M, Oliveira LB. Caries prevalence and severity, and quality of life in Brazilian 2- to 4-year-old children. Community Dent Oral Epidemiol. 2011;39:498–504. doi: 10.1111/j.1600-0528.2011.00625.x.
    1. Mickenautsch S, Yengopal V, Bonecker M, Leal SC, Bezerra ACB, Oliveira LB. MI compendium: minimum intervention (MI) - a new approach in dentistry. J Minim Interv Dent. 2013;26:1–135.
    1. Fusayama T. Two layers of carious dentin; diagnosis and treatment. Oper Dent. 1979;4:63–70.
    1. Wambier DS, dos Santos FA, Guedes-Pinto AC, Jaeger RG, Simionato MR. Ultrastructural and microbiological analysis of the dentin layers affected by caries lesions in primary molars treated by minimal intervention. Pediatr Dent. 2007;29:228–234.
    1. Thompson V, Craig RG, Curro FA, Green WS, Ship JA. Treatment of deep carious lesions by complete excavation or partial removal: a critical review. J Am Dent Assoc. 2008;139:705–712. doi: 10.14219/jada.archive.2008.0252.
    1. Bergenholtz G, Axelsson S, Davidson T, Frisk F, Hakeberg M, Kvist T, Norlund A, Petersson A, Portenier I, Sandberg H, Tranæus S, Mejare I. Treatment of pulps in teeth affected by deep caries - a systematic review of the literature. Singap Dent J. 2013;34:1–12. doi: 10.1016/j.sdj.2013.11.001.
    1. Fernandes JM, Massoni AC, Ferreira JM, Menezes VA. Use of calcium hydroxide in deep cavities of primary teeth. Quintessence Int. 2013;44:417–423.
    1. Bressani AE, Mariath AA, Haas AN, Garcia-Godoy F, de Araujo FB. Incomplete caries removal and indirect pulp capping in primary molars: a randomized controlled trial. Am J Dent. 2013;26:196–200.
    1. Casagrande L, Bento LW, Dalpian DM, García-Godoy F, de Araujo FB. Indirect pulp treatment in primary teeth: 4-year results. Am J Dent. 2010;23:34–38.
    1. Kotsanos N, Arizos S. Evaluation of a resin modified glass ionomer serving both as indirect pulp therapy and as restorative material for primary molars. Eur Arch Paediatr Dent. 2011;12:170–175. doi: 10.1007/BF03262801.
    1. Frencken JE, Pilot T, Songpaisan Y, Phantumvanit P. Atraumatic restorative treatment (ART): rationale, technique, and development. J Public Health Dent. 1996;56(3 Spec):135–140. doi: 10.1111/j.1752-7325.1996.tb02423.x.
    1. Monse B, Heinrich-Weltzien R, Benzian H, Holmgren C, van Palenstein Helderman W. PUFA--an index of clinical consequences of untreated dental caries. Community Dent Oral Epidemiol. 2010;38:77–82. doi: 10.1111/j.1600-0528.2009.00514.x.
    1. Trairatvorakul C, Sastararuji T. Indirect pulp treatment vs antibiotic sterilization of deep caries in mandibular primary molars. Int J Paediatr Dent. 2014;24:23–31. doi: 10.1111/ipd.12022.
    1. Sealed Envelope Ltd . Power calculator for binary outcome non-inferiority trial. 2012.
    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(2):85–91. doi: 10.1007/BF03320820.
    1. Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988;14:9–17.
    1. Floriano I, Gimenez T, Reyes A, Matos R, Mattos-Silveira J, Mendes FM, Braga MM. 30ª Reunião Anual da Sociedade Brasileira de Pesquisa Odontológica, 2013, Águas de Lindóia - SP. Brazilian Oral Research. São Paulo: Imprensa Cientifica; 2013. Análise de custos de diferentes abordagens para avaliação de lesões de cárie em dentes decíduos; p. 41.
    1. Leal SC, Abreu DM, Frencken JE. Dental anxiety and pain related to ART. J Appl Oral Sci. 2009;17(Suppl):84–88. doi: 10.1590/S1678-77572009000700015.

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