复合树脂常规治疗与非创伤性修复治疗在后牙乳牙中的疗效：一项随机对照试验的研究方案

Efficacy of conventional treatment with composite resin and atraumatic restorative treatment in posterior primary teeth: study protocol for a randomised controlled trial.

作者信息

Ladewig Nathalia Miranda, Sahiara Cíntia Saori, Yoshioka Laysa, Olegário Isabel Cristina, Floriano Isabela, Tedesco Tamara Kerber, Mendes Fausto Medeiros, Braga Mariana Minatel, Raggio Daniela Procida

机构信息

Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.

Department of Pediatric Dentistry, School of Dentistry, University of Ibirapuera, São Paulo, Brazil.

出版信息

BMJ Open. 2017 Jul 10;7(7):e015542. doi: 10.1136/bmjopen-2016-015542.

DOI:10.1136/bmjopen-2016-015542

PMID:28698331

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5734398/

Abstract

INTRODUCTION

Despite the widespread acceptance of conventional treatment using composite resin in primary teeth, there is limited evidence that this approach is the best option in paediatric clinics. Atraumatic restorative treatment (ART) using high-viscosity glass ionomer cement has gradually become more popular because it performs well in clinical studies, is easy to handle and is patient friendly. Therefore, the aim of this randomised clinical trial study is to compare the restoration longevity of conventional treatment using composite resin with that of ART in posterior primary teeth. As secondary outcomes, cost-efficacy and patient self-reported discomfort will also be tested.

METHODS AND ANALYSIS

Children aged 3-6 years presenting with at least one occlusal and/or occlusal-proximal cavity will be randomly assigned to one of two groups according to the dental treatment: ART (experimental group) or composite resin restoration (control group). The dental treatment will be performed at a dental care trailer located in an educational complex in Barueri/SP, Brazil. The unit of randomisation will be the child. A sample size of 240 teeth with occlusal cavities and 188 teeth with occlusal-proximal cavities has been calculated. The primary outcome will be restoration longevity, which will be clinically assessed after 6, 12, 18 and 24 months by two examiners. The duration of the dental treatment and the cost of all materials used will be considered when estimating the cost-efficacy of each treatment. Individual discomfort will be measured after each dental procedure using the Facial Scale of Wong-Baker.

ETHICS AND DISSEMINATION

This clinical trial was approved by the local ethics committee from the Faculty of Dentistry of the University of São Paulo (registration no. 1.556.018). Participants will be included after their legal guardians have signed an informed consent form containing detailed information about the research.

TRIAL REGISTRATION NUMBER

www.clinicaltrials.gov, NCT02562456; Pre-results.

摘要

引言

尽管在乳牙治疗中使用复合树脂的传统治疗方法已被广泛接受，但仅有有限的证据表明这种方法在儿科诊所是最佳选择。使用高粘度玻璃离子水门汀的非创伤性修复治疗（ART）因其在临床研究中表现良好、易于操作且对患者友好，已逐渐变得更受欢迎。因此，这项随机临床试验研究的目的是比较使用复合树脂的传统治疗方法与ART在后牙乳牙修复寿命方面的差异。作为次要结果，还将测试成本效益和患者自我报告的不适感。

方法与分析

年龄在3至6岁、至少有一个咬合面和/或咬合面 - 邻面龋洞的儿童将根据牙科治疗随机分为两组之一：ART（实验组）或复合树脂修复（对照组）。牙科治疗将在位于巴西圣保罗州巴鲁埃里市一个教育综合体内的牙科护理拖车上进行。随机分组的单位将是儿童。已计算出240颗有咬合面龋洞的牙齿和188颗有咬合面 - 邻面龋洞的牙齿作为样本量。主要结果将是修复寿命，将由两名检查人员在6、12、18和24个月后进行临床评估。在估计每种治疗的成本效益时，将考虑牙科治疗的持续时间和所使用的所有材料的成本。每次牙科治疗后，将使用面部表情疼痛量表测量个体的不适感。