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临床试验/NCT02962713
NCT02962713已完成不适用

Giomer vs Glass Ionomer Cement for ART Occlusoproximal Restorations: a Randomized Clinical Trial

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2017年11月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
182
试验地点
2
主要终点
Longevity of atraumatic restoration using Roeleveld et al. (2006) criteria

研究概览

简要总结

Although the Atraumatic Restorative Treatment (ART) is well settled in the literature regarding occlusal-proximal cavities, the longevity of these restorations is still lower when compared to occlusal ones. This factor is often associated with low mechanical properties of glass ionomer cements (GIC). The objective of this randomized clinical trial is to evaluate the long-term cost-effectiveness of two different materials: an encapsulated GIC - Equia (GC Corp), compared with Giomer (Beautifill Bulk Restorative - Shofu) used as restoratives materials in occlusal-proximal ART restorations of primary molars. Children aged between 4 and 8 years, will be selected in schools in the city of Cerquilho, São Paulo. All restorations will be held following the precepts of the ART and the manufacturer's instructions. The restorations will be evaluated after 3, 6, 12, 18 and 24 months according to Roeleveld et al. (2006) criteria. To verify the survival of the restorations will be used Kaplan-Meier survival analysis and log rank test. To evaluate the association between the clinical variables, Cox regression test will be applied. For the cost analysis will be used analysis of variance. The level of significance for all tests will be considered to 5%.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aging between 4 and 8 years
  • Children presenting good health conditions
  • Children whose parents or legal guardians accept and sign the consent form
  • Children with at least one occlusal proximal caries lesion in primary molars
  • only occlusal-proximal surfaces with caries lesions with dentin involvement

排除标准

  • severe behavioral issues
  • presence of fistula or abscess near the selected tooth
  • presence of pulp exposure in the selected tooth
  • presence of mobility in the selected tooth

结局指标

主要结局

Longevity of atraumatic restoration using Roeleveld et al. (2006) criteria

时间窗: up to 24 months

The treatments will be classified as successful when they present a clinical satisfactory aspect. Otherwise, "minor failure" will be analyzed. "Minor failures" are those in which there is a defect in the restoration, but it does not interfere in the tooth health.

次要结局

  • Cost-effiectiveness assessment(an average of 24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniela Prócida Raggio

Professor

University of Sao Paulo

研究点 (2)

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