Pulp repair response after the use of a dentin-pulp biostimulation membrane (BBio) in primary teeth: study protocol for
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STUDY PROTOCOL
Open Access
Pulp repair response after the use of a dentin-pulp biostimulation membrane (BBio) in primary teeth: study protocol for a randomized clinical trial Maria Aparecida Andrade Moreira Machado1, Tássia Carina Stafuzza1, Luciana Lourenço Ribeiro Vitor1, Silgia Aparecida da Costa2, Sirlene Maria da Costa2, Natalino Lourenço Neto1 and Thais Marchini Oliveira1,3*
Abstract Background: Vital pulp therapy aims at maintaining the pulp tissue injured but vital. Thus, the use of capping materials that induce tissue regeneration is a great current trend. This study aims to evaluate clinically and radiographically the pulp repair after the use of dentin-pulp biostimulation membrane in primary teeth. Methods: Four hundred and sixty-eight teeth from children aged between 5 and 9 years old, both genders, with deep caries lesion with pulp involvement, but no furcal impairment and any sign of necrosis will be selected. The vital pulp therapy will be performed with mineral trioxide aggregate (control group) and dentin-pulp biostimulation chitosan membrane (BBio group). The clinical and radiographic outcomes will be assessed at 12 and 24 months after treatment. The thickness of the dentin barrier will be verified through Image J2 software. The Wilcoxon signed rank test and Mann-Whitney test will respectively compare the intra- and intergroup clinical and radiographic outcomes. Paired t test and independent t test will respectively compare the intra- and intergroup radiographic measurements. The logistic regression will be applied, and the degrees of this association will be measured using odds ratio (OR) and 95% confidence interval (95% CI). Discussion: Therefore, this study protocol aims at new perspectives of vital pulp therapy of primary teeth by employing new easy-handling, low-cost material to keep viable the pulp tissue capable of regenerating and maintain the physiological process of deciduous tooth exfoliation. Trial registration: Brazilian Registry of Clinical Trials RBR-6vr58b. Registered on 17 February 2019. Keywords: Vital pulp therapy, Pulpotomy, Chitosan, Tooth, Deciduous, Pulp
* Correspondence: [email protected] 1 Department of Pediatric Dentistry, Orthodontics and Public Health, School of Dentistry of Bauru, University of São Paulo, Bauru, São Paulo, Brazil 3 Hospital for the Rehabilitation of Craniofacial Anomalies, University of São Paulo, Bauru, São Paulo, Brazil Full list of author information is available at the end of the article
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