Effect of Shortening the Etching Time on the Clinical Performance of Resin Composite Restorations in Primary Teeth
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Failure of restorations
研究概览
简要总结
The aim of this study is to evaluate the effect of shortening the etching time on the 18-month clinical performance of resin composite restorations in primary molars after partial carious removal. This randomized clinical trial will include subjects (5-10 year-old children) selected at Pediatric Clinic of Federal University of Santa Maria. The sample will consist of 70 primary molars presenting active cavitated carious lesions (with radiographic involvement of the outer half of the dentin), located on the occlusal surface. The sample will be randomly divided into two groups according to the etching time of the dentin prior adhesive application (Adper Single Bond 2; 3M ESPE): recommend by manufacturers (15 seconds) and half-reduced etching time (7 seconds). The restorations will be clinically followed every 6 months for up to 18-month using the FDI criteria for clinical evaluation. Survival estimates for restoration longevity will be evaluated using the Kaplan-Meier method.
详细描述
The aim of this study is to evaluate the effect of shortening the etching time on the 18-month clinical performance of resin composite restorations in primary molars after partial carious removal. This randomized clinical trial will include subjects (5-10 year-old children) selected at Pediatric Clinic of Federal University of Santa Maria. The sample will consist of 70 primary molars presenting active cavitated carious lesions (with radiographic involvement of the outer half of the dentin), located on the occlusal surface. The sample will be randomly divided into two groups according to the etching time of the dentin prior adhesive application (Adper Single Bond 2; 3M ESPE): applying of 35% phosphoric acid by 15 s - recommend by manufacturers and half-reduced etching time (7 s). The restorations will be clinically followed every 6 months for up to 18-month using the FDI criteria for clinical evaluation. Survival estimates for restoration longevity will be evaluated using the Kaplan-Meier method.
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 surfaces of primary molars.
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.
研究组 & 干预措施
Total etching time
Dentin etching (35% phosphoric acid) by time recommend by manufacturer (15 seconds)
干预措施: Total etching time (Other)
Half-reduced etching time
Dentin etching (35% phosphoric acid) by 7 seconds
干预措施: Half-reduced etching time (Other)
结局指标
主要结局
Failure of restorations
时间窗: 18 months after restorations' placement
次要结局
未报告次要终点
研究者
Tathiane Lenzi
Principal investigator
Universidade Federal de Santa Maria