A 2-year Clinical Study on Postoperative Pulpal Complications Arising From the Absence of a Glass-ionomer Lining in Deep Occlusal Resin Composite Restorations
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Postoperative pulpal complications
研究概览
简要总结
The purpose of this study is to observe the effects of glass-ionomer cement (GIC) lining on risk of pulpal complications in deep occlusal cavities with resin-based restorations.
详细描述
Fifty three patients aged 18-30 years who had one or two deep occlusal carious lesions (≥ 3 mm in depth) in molars were recruited. Dental caries was removed and the prepared cavity was restored with resin composite using one of two restorative procedures: (1) without GIC lining; (2) with (resin-modified) GIC lining. Restored teeth were evaluated for any pulpal complications (subjective symptoms, objective signs or loss of tooth vitality) at one month (baseline), one year and two years after restoration.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Deep dental caries on occlusal surfaces of molar teeth
排除标准
- •Shallow and moderate-depth caries
- •Caries exposed pulp
研究组 & 干预措施
Glass-ionomer cement lining
Presence of glass-ionomer cement lining in posterior resin composite restorations.
干预措施: Glass ionomer cement lining (Procedure)
No glass-ionomer cement lining
Absence of glass-ionomer cement lining in posterior resin composite restorations
干预措施: Glass ionomer cement lining (Procedure)
结局指标
主要结局
Postoperative pulpal complications
时间窗: 2 years
Signs and symptoms (subjective/objective) of pulpal \& periapical diseases. Response to electrical pulp testing.
次要结局
未报告次要终点