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

Trials

Sirlene Maria da Costa¹  Silgia Aparecida da Costa¹  Luciana Lourenço Ribeiro Vitor²  Maria Aparecida Andrade Moreira Machado²  Natalino Lourenço Neto²  Tássia Carina Stafuzza²  Thais Marchini Oliveira³ 

[1] Course on Textiles and Fashion, School of Arts, Sciences and Humanities, University of São Paulo, São Paulo, Brazil;Department of Pediatric Dentistry, Orthodontics and Public Health, School of Dentistry of Bauru, University of São Paulo, Bauru, São Paulo, Brazil;Department of Pediatric Dentistry, Orthodontics and Public Health, School of Dentistry of Bauru, University of São Paulo, Bauru, São Paulo, Brazil;Hospital for the Rehabilitation of Craniofacial Anomalies, University of São Paulo, Bauru, São Paulo, Brazil;

关键词: Vital pulp therapy;    Pulpotomy;    Chitosan;    Tooth;    Deciduous;    Pulp;   

DOI  :  10.1186/s13063-020-04785-2

来源: Springer

【 摘 要 】

BackgroundVital 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.MethodsFour 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).DiscussionTherefore, 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 registrationBrazilian Registry of Clinical Trials RBR-6vr58b. Registered on 17 February 2019.

【 授权许可】

CC BY