Clinical Evaluation of a Bioactive Material
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Clinical performances of different restorative systems according to FDI criteria
研究概览
简要总结
The clinical performance of a bioactive composite and a posterior resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. All caries lesions will be removed before restoring. Cavities will be divided into two groups: a bioactive composite [Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)] and a posterior resin composite [G-ænial Posterior (GC, Tokyo, Japan) (GP)] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using FDI criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age range will be 18 to 65
- •patients should have at least 2 approximal caries lesions require restoration
- •healthy periodontal status
- •a good likelihood of recall availability
排除标准
- •poor gingival health
- •adverse medical history
- •potential behavioral problems
结局指标
主要结局
Clinical performances of different restorative systems according to FDI criteria
时间窗: two years
Two year results according to FDI criteria
次要结局
未报告次要终点
研究者
Dr. Fatma Dilşad Öz
Assoc. Prof. Dr.
Hacettepe University