Alternative Treatment of Deep Caries Lesions Based on Biological Evidences
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 329
- 试验地点
- 3
- 主要终点
- Pulp sensitivity
研究概览
简要总结
The aim of this multicenter randomized controlled clinical trial is to evaluate the effectiveness of an alternative treatment for deep caries lesions in Public Health Services. The alternative treatment consists of partial removal of carious dentine followed by restoration. The subjects were assigned to test or control groups: test - carious dentine partial removal and restoration in one session, and control - stepwise excavation. The stepwise excavation consists of partial removal of carious tissue from the cavity floor, indirect pulp capping with calcium hydroxide cement; temporary filling; cavity re-opening after 60 days, removal of the remaining soft carious tissue and filling. Each group was divided according to the filling material: amalgam or resin. The radiological exams are being performed before and after the treatment and then annually. Clinical evaluation of the restorations is performed right after the treatment and then annually (modified USPHS System). All evaluations are performed by calibrated and trained dentists.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients ≥ nine years old;
- •permanent molars with primary deep caries lesion reaching dentine inner half (radiographic exam);
- •pulpal sensibility positive (cold test);
- •absence of spontaneous pain;
- •absence of periapical alterations (radiographic exam);
- •negative percussion test.
排除标准
- •subjects with general diseases affecting their caries experience;
- •caries lesion evolving an entire cusp;
- •caries lesion with cervical margin in dentine.
结局指标
主要结局
Pulp sensitivity
时间窗: Once a year during at least five years
次要结局
- Remineralization of the residual caries (measure through digital substraction of radiographic exams)(Once a year during at least five years)
- Cost-effectiveness analysis(During five years of follow-up)
- Clinical evaluation of amalgam and resin restorations (USPHS criteria)(Once a year during at least five years)