Pulp liner materials in selective caries removal: study protocol for a randomised controlled trial

Tássia Carina Stafuzza; Luciana Lourenço Ribeiro Vitor; Natalino Lourenço Neto; Daniela Rios; Thiago Cruvinel; Vivien Thiemy Sakai; Ana Beatriz Silveira Moretti; Maria Aparecida Andrade Moreira Machado; Thais Marchini Oliveira

doi:10.1136/bmjopen-2019-029612

Pulp liner materials in selective caries removal: study protocol for a randomised controlled trial

BMJ Open. 2021 Jan 8;11(1):e029612. doi: 10.1136/bmjopen-2019-029612.

Authors

Tássia Carina Stafuzza¹, Luciana Lourenço Ribeiro Vitor¹, Natalino Lourenço Neto¹, Daniela Rios¹, Thiago Cruvinel¹, Vivien Thiemy Sakai², Ana Beatriz Silveira Moretti², Maria Aparecida Andrade Moreira Machado¹, Thais Marchini Oliveira^{3

4}

Affiliations

¹ Department of Pediatric Dentistry, Orthodontics and Public Health, School of Dentistry of Bauru, University of São Paulo, São Paulo, Brazil.
² Department of Clinics and Surgery, School of Dentistry, Federal University of Alfenas, Alfenas, Brazil.
³ Department of Pediatric Dentistry, Orthodontics and Public Health, School of Dentistry of Bauru, University of São Paulo, São Paulo, Brazil marchini@usp.br.
⁴ Department of Pediatric Dentistry, Hospital for the Rehabilitation of Craniofacial Anomalies, University of São Paulo, São Paulo, Brazil.

Abstract

Introduction: The literature shows that selective carious tissue removal (SCTR) decreases the number and diversity of bacteria, stops the caries process and reduces the risk of pulp exposure. However, no consensus exists on which pulp liner would be suitable for teeth undergoing SCTR. So, this study will verify the in vivo response of dentine-pulp complex after SCTR in primary teeth with or without pulp liner material.

Methods and analysis: A randomised clinical trial, double-blinded, parallel-group and allocation concealment will be conducted with the enrolment of 384 patients from 5 to 9 years, with one maxillary/mandibular first/second primary molars with deep occlusal/occlusoproximal cavities. The remaining dentine will be lined with calcium hydroxide cement-group 1; mineral trioxide aggregate-group 2 and without liner-group 3. The primary outcome will be success of the of dentine-pulp complex evaluated clinically and radiographically at 6, 12 and 24 months, while the secondary outcomes will be the measurement of the dentine barrier on periapical radiographs. During all study, two trained and calibrated examiners will evaluate the treated teeth clinically and radiographically. Interexaminer and intraexaminer reliability will be verified by casual and systematic error. The Kolmogorov-Smirnov test will be adopted to test the normality of continuous variables. Comparisons among groups will be performed by using the χ² test and anaylsis of variance, followed by Tukey test (p<0.05). The logistic regression will be applied, and the degrees of this association will be measured using the OR and 95% CI.

Ethics and dissemination: The present protocol was submitted and approved by the Ethical Committee of the University of São Paulo, Bauru, São Paulo, Brazil (CAAE: 79123517.0.0000.5417). Consent for publication will be obtained from all parents or legal guardians. Results of this study will be reported in full through peer-reviewed journals.

Trial registration number: RBR-9fsxnn.

Keywords: paediatric oral & maxillofacial surgery; protocols & guidelines; quality in health care.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Brazil
Dental Caries Susceptibility*
Dental Caries* / therapy
Humans
Molar / diagnostic imaging
Randomized Controlled Trials as Topic
Reproducibility of Results
Tooth, Deciduous