Longevity of Restoration Repairs Using Composite Resin Versus High Viscosity Glass Ionomer in Primary Molars: Randomized Clinical Trial
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
- 否
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
Daniela Prócida Raggio
Professor Doctor
University of Sao Paulo
