Stafuzza Tássia Carina, Vitor Luciana Lourenço Ribeiro, Lourenço Neto Natalino, Rios Daniela, Cruvinel Thiago, Sakai Vivien Thiemy, Moretti Ana Beatriz Silveira, Machado Maria Aparecida Andrade Moreira, Oliveira Thais Marchini
Department of Pediatric Dentistry, Orthodontics and Public Health, School of Dentistry of Bauru, University of São Paulo, São Paulo, Brazil.
Department of Clinics and Surgery, School of Dentistry, Federal University of Alfenas, Alfenas, Brazil.
BMJ Open. 2021 Jan 8;11(1):e029612. doi: 10.1136/bmjopen-2019-029612.
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.
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 χ 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.
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.
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文献表明，选择性龋损组织去除术（SCTR）可减少细菌数量和多样性，阻止龋病进程并降低牙髓暴露风险。然而，对于哪种牙髓衬层材料适用于接受SCTR的牙齿，目前尚无共识。因此，本研究将验证在有或没有牙髓衬层材料的乳磨牙中进行SCTR后牙本质-牙髓复合体的体内反应。
将进行一项随机临床试验，采用双盲、平行组和分配隐藏设计，纳入384名5至9岁的患者，其一侧上颌/下颌第一/第二乳磨牙有深咬合面/咬合邻面龋洞。剩余牙本质将分别用氢氧化钙水门汀衬层（第1组）、三氧化矿物凝聚体衬层（第2组），不使用衬层（第3组）。主要结局将是在6、12和24个月时通过临床和影像学评估牙本质-牙髓复合体的成功情况，次要结局将是根尖片上牙本质屏障的测量。在整个研究过程中，两名经过培训和校准的检查者将对治疗后的牙齿进行临床和影像学评估。检查者间和检查者内的可靠性将通过偶然误差和系统误差进行验证。将采用柯尔莫哥洛夫-斯米尔诺夫检验来检验连续变量的正态性。组间比较将采用χ检验和方差分析，随后进行Tukey检验（p<0.05）。将应用逻辑回归分析，并使用OR和95%CI来衡量这种关联的程度。
本研究方案已提交并获得巴西圣保罗大学鲍鲁分校伦理委员会批准（CAAE：79123517.0.0000.5417）。将获得所有家长或法定监护人的发表同意书。本研究结果将通过同行评审期刊完整报告。
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