Pulp repair response after the use of a dentin-pulp biostimulation membrane (BBio) in primary teeth: study protocol for a randomized clinical trial

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 biostimu...

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Main Authors: Maria Aparecida Andrade Moreira Machado, Tássia Carina Stafuzza, Luciana Lourenço Ribeiro Vitor, Silgia Aparecida da Costa, Sirlene Maria da Costa, Natalino Lourenço Neto, Thais Marchini Oliveira
Format: Article
Language:English
Published: BMC 2020-10-01
Series:Trials
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13063-020-04785-2
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author Maria Aparecida Andrade Moreira Machado
Tássia Carina Stafuzza
Luciana Lourenço Ribeiro Vitor
Silgia Aparecida da Costa
Sirlene Maria da Costa
Natalino Lourenço Neto
Thais Marchini Oliveira
author_facet Maria Aparecida Andrade Moreira Machado
Tássia Carina Stafuzza
Luciana Lourenço Ribeiro Vitor
Silgia Aparecida da Costa
Sirlene Maria da Costa
Natalino Lourenço Neto
Thais Marchini Oliveira
author_sort Maria Aparecida Andrade Moreira Machado
collection DOAJ
description 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.
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spelling doaj.art-ba33160134d04cb0a37a3a5b634423ef2022-12-22T00:28:14ZengBMCTrials1745-62152020-10-012111710.1186/s13063-020-04785-2Pulp repair response after the use of a dentin-pulp biostimulation membrane (BBio) in primary teeth: study protocol for a randomized clinical trialMaria Aparecida Andrade Moreira Machado0Tássia Carina Stafuzza1Luciana Lourenço Ribeiro Vitor2Silgia Aparecida da Costa3Sirlene Maria da Costa4Natalino Lourenço Neto5Thais Marchini Oliveira6Department of Pediatric Dentistry, Orthodontics and Public Health, School of Dentistry of Bauru, University of São PauloDepartment of Pediatric Dentistry, Orthodontics and Public Health, School of Dentistry of Bauru, University of São PauloDepartment of Pediatric Dentistry, Orthodontics and Public Health, School of Dentistry of Bauru, University of São PauloCourse on Textiles and Fashion, School of Arts, Sciences and Humanities, University of São PauloCourse on Textiles and Fashion, School of Arts, Sciences and Humanities, University of São PauloDepartment of Pediatric Dentistry, Orthodontics and Public Health, School of Dentistry of Bauru, University of São PauloDepartment of Pediatric Dentistry, Orthodontics and Public Health, School of Dentistry of Bauru, University of São PauloAbstract 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.http://link.springer.com/article/10.1186/s13063-020-04785-2Vital pulp therapyPulpotomyChitosanToothDeciduousPulp
spellingShingle Maria Aparecida Andrade Moreira Machado
Tássia Carina Stafuzza
Luciana Lourenço Ribeiro Vitor
Silgia Aparecida da Costa
Sirlene Maria da Costa
Natalino Lourenço Neto
Thais Marchini Oliveira
Pulp repair response after the use of a dentin-pulp biostimulation membrane (BBio) in primary teeth: study protocol for a randomized clinical trial
Trials
Vital pulp therapy
Pulpotomy
Chitosan
Tooth
Deciduous
Pulp
title Pulp repair response after the use of a dentin-pulp biostimulation membrane (BBio) in primary teeth: study protocol for a randomized clinical trial
title_full Pulp repair response after the use of a dentin-pulp biostimulation membrane (BBio) in primary teeth: study protocol for a randomized clinical trial
title_fullStr Pulp repair response after the use of a dentin-pulp biostimulation membrane (BBio) in primary teeth: study protocol for a randomized clinical trial
title_full_unstemmed Pulp repair response after the use of a dentin-pulp biostimulation membrane (BBio) in primary teeth: study protocol for a randomized clinical trial
title_short Pulp repair response after the use of a dentin-pulp biostimulation membrane (BBio) in primary teeth: study protocol for a randomized clinical trial
title_sort pulp repair response after the use of a dentin pulp biostimulation membrane bbio in primary teeth study protocol for a randomized clinical trial
topic Vital pulp therapy
Pulpotomy
Chitosan
Tooth
Deciduous
Pulp
url http://link.springer.com/article/10.1186/s13063-020-04785-2
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