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临床试验/NCT02274142
NCT02274142已完成不适用

Minimally Invasive Restorations in Primary Molars Using Encapsulated ou Hand-mixed Glass Ionomer Cement: Clinical Trial With 24 Months of Follow-up

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
145
试验地点
2
主要终点
Restorations survival

研究概览

简要总结

The aim of this RCT is to evaluate the survival of different glass ionomer cement in minimally invasive restorations, with different handling characteristics: hand-mixed versus encapsulated.

详细描述

Detailed Description: This study was approved by the research ethics committee of the School of Dentistry (University of São Paulo, Brazil) and written informed consent will be obtained from the parents or legal guardians. The sample size was calculated based on the data obtained in a systematic review, which reported average longevity of 78% after 2 years of follow up (mean survival of occlusal and occlusoproximal surfaces). The minimum difference of 15% in the success rate between the control and treatment groups after 2 years of follow-up, with and α of 5% and power (strength) of 80% using paired test. As more than one tooth per children might be included, we must add a 20% for clustering. Adding 20% for possible losses the final estimate is 116 teeth per group, reaching a final sample of 232 teeth.

Inclusion Criteria:

  • Children who have sought treatment in the School of Dentistry, University of Sao Paulo;
  • Children between 3 and 10 years old without systemic diseases;
  • Children presenting at least one dentin caries cavity in primary teeth (occlusal or oclusoproximal) with no signs of pulp involvement.

Exclusion Criteria:

  • Children whose parents did not agree to participate in the study;
  • Children with behavioural issues at the initial exam or who did not assent to participate in the study.

研究设计

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

入排标准

年龄范围
3 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Children whose parents did not agree to participate in the study;
  • Children with behavioural issues at the initial exam or who did not assent to participate in the study.

结局指标

主要结局

Restorations survival

时间窗: 24 months

The survival of restorations will be evaluated over 24 months according to the Frencken and Holmgren (1999) index for occlusal cavities and Roeleveld (2006) for occlusoproximal cavities.

次要结局

  • Cost-Effectiveness(24 months)

研究者

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

Daniela Prócida Raggio

Associate Professor

University of Sao Paulo

研究点 (2)

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