NCT06029023已完成1 期
Clinical And Radiographic Evaluation of Nano-Propolis, Nano-Curcumin and MTA as Direct Pulp Capping Agents in Young Permanant Teeth
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Incidence of pain or swelling
研究概览
简要总结
The aim of the study is to evaluate clinical and radiographic effect of nano propolis and nano curcumin as direct pulp capping agents in young permanent teeth.
.
详细描述
I. Materials:
- Mineral trioxide aggregate (MTA)
- Nano propolis
- Nano curcumin
- Glass ionomer
II. Methods:
Sample size calculation:
Sample size calculation was performed using G*Power version 3.1.9.7 based on the results of a previous study. The predicted sample size (n) was (54), i.e., 18 samples per group of the three groups, to detect results of dentin bridge thickness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Young permanent teeth with deep carious lesions that led to a caries-exposed pulp after spoon excavation and a diagnosis of reversible pulpitis.
- •The tooth has a pulp exposure caused by trauma that occurred within 48 h.
排除标准
- •The patient has a history of systemic disease that interferes with pulp healing.
- •The tooth has clinical signs and symptoms of irreversible pulpitis, e.g., spontaneous throbbing pain, tenderness to percussion, abnormal tooth mobility, swelling, or sinus tract.
- •Radiographic evidence of internal or external resorption, inter-radicular bone loss, or periapical pathology.
- •The tooth was non-restorable. During the study, if any symptoms of irreversible pulpitis, apical periodontitis, or infection occurred, the patients received the appropriate treatment following the institute protocol, including regenerative and root canal treatment.
结局指标
主要结局
Incidence of pain or swelling
时间窗: 1 week ,3 month , 6 month
questionnaire applied for patient
次要结局
- increase thickness of dentin bridge(baseline ,6 month)
研究者
Dalia Mohamed Elasser
Principal Investigator
Al-Azhar University
研究点 (2)
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