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Open Access 01-12-2020 | Study protocol

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

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

Published in: Trials | Issue 1/2020

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.

Available only for authorised users

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Title: Pulp repair response after the use of a dentin-pulp biostimulation membrane (BBio) in primary teeth: study protocol for a randomized clinical trial
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
Publication date: 01-12-2020
Publisher: BioMed Central
Published in: Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-020-04785-2

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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