Performance of Universal Adhesive in Primary Molars: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Longevity of restoration
研究概览
简要总结
The aim of this study is to evaluate the 18-month clinical performance of a multimode adhesive (Scotchbond Universal Adhesive, 3M ESPE, St Paul, MN, USA) in primary molars after partial carious removal. This randomized clinical trial will include subjects (5-10 year-old children) selected at two university centers (UFSM and FOUSP). The sample will consist of 132 primary molars presenting active cavitated carious lesions (with radiographic involvement of the outer half of the dentin), located on the occlusal and occlusal-proximal surface. The sample will be randomly divided into two groups according to bonding approach: etch-and-rinse or self-etch strategy. The restorations will be clinically followed every 6 months for up to 18 months using the USPHS modified criteria for clinical evaluation. Survival estimates for restoration longevity will be evaluated using the Kaplan-Meier method.
详细描述
Randomized clinical trials of performance of universal adhesive in primary molars
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •active carious lesion in middle dentin limited to the occlusal or occluso-proximal surfaces of primary molars;
- •children (male or female) in good general health.
排除标准
- •children who refuse or fail to cooperate with the completion of clinical procedure; - teeth without antagonist;
- •carious lesions in inner half of dentin;
- •presence of painful symptoms or signs of pulpal changes.
结局指标
主要结局
Longevity of restoration
时间窗: 18-month follow up
The outcome of the study is the failure of restorations in primary teeth. Failures will be assessed by clinical evaluation and will be considered in the presence of loss of restoration or fracture requiring a reintervation (restoration repair or replacement) or symptoms requiring pulp intervention or tooth extraction.
次要结局
未报告次要终点
研究者
Rachel de Oliveira Rocha
Rachel de Oliveira Rocha
Universidade Federal de Santa Maria