Stainless steel crown vs bulk fill composites for the restoration of primary molars post-pulpectomy: 1-year survival and acceptance results of a randomized clinical trial

I.C. Olegário, C.R. Bresolin, A.L. Pássaro, M.P. de Araujo, D. Hesse, F.M. Mendes, D.P. Raggio

Research output: Contribution to JournalArticleAcademicpeer-review

Abstract

Background: A key factor for the success and longevity of the endodontic treatment is sealing of the cavity after restorative treatment. Aim: The aim of this randomised clinical trial was to evaluate the 1-year survival of endodontic treatment in primary molars restored with stainless steel crowns (SSCs) and bulk fill composite resin (BF). As a secondary outcome, the acceptance of both children and parents was evaluated. Design: Ninety-one 3- to 8-year-old children with at least one primary molar requiring endodontic treatment were selected. Participants were randomized to SSC or BF and evaluated after 1, 3, 6, and 12 months. An acceptance questionnaire was completed immediately after the treatment. The primary outcome was the endodontic treatment success, evaluated in the intention-to-treat (ITT) population using the Kaplan-Meier and non-inferiority Cox regression analyses, with a non-inferiority limit of 15%. Sensitivity analysis between the success rates after 1 year was performed using Miettinen-Nurminen's method. The Mann-Whitney test was used to compare the treatment acceptance (α = 5%). Results: The survival rate after 1 year was BF = 75% and SSC = 88% (HR = 1.41; 90% CI 0.57-3.43). ITT analysis showed a success rate of BF = 86.7% and SSC = 82.6% (RR = 0.95; 0.78-1.16). The non-inferiority hypothesis between the survival of endodontic treatment could not be proved in both analyses (P >.05). The overall acceptance scores did not differ between the restorative groups (P >.05). Conclusion: This study failed to show non-inferiority of BF compared with the SSC. The materials were well accepted by both children and their parents.
Original languageEnglish
Pages (from-to)11-21
Number of pages11
JournalInternational Journal of Paediatric Dentistry
Volume32
Issue number1
Early online date16 Mar 2021
DOIs
Publication statusPublished - Jan 2022

Bibliographical note

Publisher copyright:
© 2021 The Authors. International Journal of Paediatric Dentistry published by BSPD, IAPD and John Wiley & Sons Ltd.

Funding

The authors would like to thank 3M ESPE that donated some materials (Filtek Bulk fill composite resin and Scotchbond Universal Adhesive). We also would like to thank Dr Anne O'Connell and Dr Rona Leith for kindly for reviewing the English language of this study. Staff time and resources for the trial have been supported through the University of Sao Paulo (USP) and CEPEC (Centre for Clinical Research). This study was partially supported by the National Council for Scientific and Technological Development from the Brazilian Government (Grant Nos.: 309521/2015‐7 and 306304/2015‐5). The authors would like to thank 3M ESPE that donated some materials (Filtek Bulk fill composite resin and Scotchbond Universal Adhesive). We also would like to thank Dr Anne O'Connell and Dr Rona Leith for kindly for reviewing the English language of this study. Staff time and resources for the trial have been supported through the University of Sao Paulo (USP) and CEPEC (Centre for Clinical Research). This study was partially supported by the National Council for Scientific and Technological Development from the Brazilian Government (Grant Nos.: 309521/2015-7 and 306304/2015-5).

FundersFunder number
CEPEC
Centre for Clinical Research
Governo Brasil309521/2015‐7, 306304/2015‐5
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Universidade de São Paulo

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