NCT07432724尚未招募不适用
A Prospective Clinical Evaluation of Bioactive Restorative System in Controlled Diabetic and Non Diabetic Patients: An 18-Month Non-Randomized Comparative Study.
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Marginal discoloration
研究概览
简要总结
This study is conducted to evaluate the 18-month clinical performance of complete bioactive restorative system for occlusal restorations between diabetic and non-diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients indicated for a Class I posterior composite restoration
- •permanent tooth
- •ICDAS 3 or 4
排除标准
- •uncontrolled diabetic patients
- •primary dentition
- •special needs
研究组 & 干预措施
diabetic patients
Experimental
干预措施: bioactive composite (Other)
Non diabetic patients
Experimental
干预措施: bioactive composite (Other)
结局指标
主要结局
Marginal discoloration
时间窗: T0: Baseline T1: 6 months T2: 12 months T3: 18 month
Measuring device: Modified USPHS criteria
次要结局
- Marginal adaptation, color match, secondary caries, Retention, wear, and postoperative sensitivity.(T0: baseline T1: 6 months T2: 12 months T3: 18 months)
研究者
Sara Mohamed Hassan
Assistant lecturer
Cairo University
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