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Effectiveness of Atraumatic Restorative Treatment Using Glass Ionomer Cement of Different Costs (SLM1797)

2017年11月6日 更新者:Jose Carlos P Imparato、Faculty Sao Leopoldo Mandic Campinas

Effectiveness of Atraumatic Restorative Treatment Using Glass Ionomer Cement of Different Costs: a Randomized Controlled Trial

Atraumatic Restorative Treatment (ART) is an alternative restorative technique for dental caries, applying the partial caries tissue removal philosophy using hand instruments, relative cotton rolls isolation, immediate restoration with Glass Ionomer Cements (GIC) and avoiding local anesthesia. The chosen material for this study will be the High Viscosity Glass Ionomer Cement (HVGIC) due to its unique physical-chemical properties as well as its applicability in challenging clinical situations where other materials would not be adequate. Although there are substantial evidences regarding GIC properties, information about GIC (with different costs) longevity is still weak. Therefore, the objective of this study is to assess the effectiveness of ART restorations performed with low-cost HVGIC in cavitated dentine carious lesions in primary and permanent molars. This will be a multicenter randomized controlled double-blind (patient and operator) clinical trial performed with 680 primary and/or permanent molars in children between 4 and 9 years old presenting cavitated dentine carious lesions in occlusal and occlusal-proximal surfaces. The tooth will be considered as the unit sample, which will be randomly allocated to the groups through a generated random list numbers and distributed in dark sealed envelopes opened only by dental assistants. Teeth in the test group will be submitted to restorative treatment with HVGIC Vitro Molar and those in the control group with HVGIC Fuji IX. The restoration effectiveness will be assessed by means of both clinical and bitewing x-rays control after 6 and 12 months.

研究概览

地位

完全的

条件

研究类型

介入性

注册 (实际的)

574

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Sao Paulo
      • Campinas、Sao Paulo、巴西、13045755
        • Faculty Sao Leopoldo Mandic

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

4年 至 9年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Children with at least one primary and/or permanent molar with dentine carious lesion in the occlusal and/or occlusal-proximal surface.

Exclusion Criteria:

  • Special need patients, subjects under orthodontic treatment and/or systemically compromised.
  • Teeth with restorations, sealants, developmental defects, deep carious lesions with pulpal exposure risk, fistula and/or abscess, and those with history of spontaneous pain.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:High Cost
Restoration using a high-cost glass ionomer cement.
Surfaces allocated to this group will be treated with a high-cost glass ionomer cement restoration (Fuji IX, GC America, USA), according to the manufacturer's instructions.
实验性的:Low Cost
Restoration using a low-cost glass ionomer cement.
Surfaces allocated to this group will be treated with a low-cost glass ionomer cement restoration (Maxxion R, FGM, BRA), according to the manufacturer's instructions.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Restoration survival
大体时间:12 months
The restoration will be classified according to the scores described by Frencken et al. (1994) and Roeleveld et al. (2006).
12 months

次要结果测量

结果测量
措施说明
大体时间
Cost-effectiveness
大体时间:Through study completion (12 months)
The costs of each treatment procedure will be calculated and compared with thresholds values for intervention cost-effectiveness by region, determined by World Health Organization (http://www.who.int/choice/costs/CER_levels/en/).
Through study completion (12 months)
Impact on children's quality of life
大体时间:Baseline and 12 months
The oral health related quality of life will be measured using a validated questionnaire according to the children's age. The "Early Childhood Oral Health Impact Scale" (ECOHIS) (Tesch et al., 2008) will be applied with 4-5 years old children. The "Child Perceptions Questionnaire" (CPQ) will be used for 6-9 years old children (Martins et al., 2009). They will be applied immediately before the procedure and on 12 months follow-up.
Baseline and 12 months
Children self-reported discomfort
大体时间:Baseline
The discomfort of each treatment will be evaluated using the facial scale of Wong-Baker (Wong, Baker, 1988). The patient will be asked to choose the face that is more similar to how he/she felt during the treatment. The answer should be given solely by the child, which means no parental or professional interferences.
Baseline
Caries lesions progression
大体时间:Every 6 months up to 12 months
The treatments will be evaluated radiographically. This evaluation will be performed by two blinded examiners, which will evaluate the four patients' radiographies (baseline, after treatment, 6 months, 12 months) independently, two by two, without knowing the chronological order of them. The efficacy of the treatment will be related to the presence or absence of increasing radiolucent area. They will also classify each radiography using Ekstrand criteria (Ekstrand et al., 1997) and analyze them in a software (ImageJ 1.49, National Institute of Health, USA) in order to make the radiographic subtraction.
Every 6 months up to 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jose Carlos P Imparato, PhD、Faculty Sao Leopoldo Mandic

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年4月1日

初级完成 (实际的)

2016年11月1日

研究完成 (实际的)

2017年11月1日

研究注册日期

首次提交

2016年4月7日

首先提交符合 QC 标准的

2016年5月17日

首次发布 (估计)

2016年5月20日

研究记录更新

最后更新发布 (实际的)

2017年11月8日

上次提交的符合 QC 标准的更新

2017年11月6日

最后验证

2017年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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