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临床试验/NCT04491981
NCT04491981Unknown不适用

Longevity of Restoration Repairs Using Composite Resin Versus High Viscosity Glass Ionomer in Primary Molars: Randomized Clinical Trial

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 312 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
312
试验地点
2
主要终点
Clinical success of restorations after repair

研究概览

简要总结

The objective of this randomized clinical study is to evaluate the survival of repairs in restorations using composite resin (CR) or high viscosity glass ionomer cement (GIC) in primary molars. This trial is nested to another study (NCT03520309), so patients will be enrolled from CARDEC 3. 312 restorations will be included and randomized into two groups: glass ionomer cement (Riva Self Cure, SDI, Australia) and composite resin (Filtek Bulk Fill and Filtek Bulk Fill Flow, 3M ESPE, USA). After the end of treatments, patients will be followed for 24 months to assess the success of the restorations, which will be considered as the absence of the need for reintervention. The Kaplan-Meier survival curves and the log-rank tests will be performed to assess survival between groups and Cox regression analysis will be used to compare the outcome with the variables (α = 5%).

详细描述

Failed restorations in primary teeth will be repaired using GIC or composite resin.

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
None

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

  • Children who have sought treatment in the School of Dentistry, University of Sao Paulo
  • Children between 3 and 10 years old
  • Children presenting at least one restoration (of any material, any surface and any integrity status) in primary teeth

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

Clinical success of restorations after repair

时间窗: 24 months

Visual assessment using Frencken criteria for occlusal restoration and Roeleveld et al. criteria for occlusoproximal restorations

次要结局

  • Cost- effectiveness of restorations repairs(24 months)
  • Patient's discomfort(baseline)

研究者

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

Daniela Prócida Raggio

Professor Doctor

University of Sao Paulo

研究点 (2)

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