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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
Author(s) -
Olegário Isabel Cristina,
Bresolin Carmela Rampazzo,
Pássaro Ana Laura,
Araujo Mariana Pinheiro,
Hesse Daniela,
Mendes Fausto Medeiros,
Raggio Daniela Prócida
Publication year - 2022
Publication title -
international journal of paediatric dentistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.183
H-Index - 62
eISSN - 1365-263X
pISSN - 0960-7439
DOI - 10.1111/ipd.12785
Subject(s) - medicine , pulpectomy , dentistry , molar , randomized controlled trial , mann–whitney u test , survival rate , population , clinical trial , crown (dentistry) , intention to treat analysis , surgery , environmental health
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.