NCT04488679Unknown不适用
Clinical and Radiographic Assessment of Platelet Rich Fibrin and Mineral Trioxide Aggregate as Pulp Capping Biomaterials: A Randomized Control Trial
Rahma Ahmed Ibrahem Hafiz2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2022年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- clinical success rate
研究概览
简要总结
eligible carious teeth with exposed pulp by the undergraduate students will be randomly divided into two groups to be treated with direct pulp capping (A), where (A1) represents the comparator group where teeth will be treated with direct application of MTA over the exposed pulp, (A2) represents teeth to be treated with the application of PRF directly over exposed pulp followed by MTA application. clinical and radiographic assessment of tooth vitality, history of pain, pain on percussion, and dentin bridge formation will be performed at baseline, 6 months, and 1 year
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 (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient aged 15:40 years old.
- •Patients exhibiting pulp exposure (carious, traumatic, or mechanical) during management of active carious lesions with less than 2 mm of carious exposure.
- •Signs and symptoms indicative of pulp vitality, i.e. a positive response to thermal stimulation during a cold test.
- •periapical radiograph showing closed apex and normal periapex
排除标准
- •Teeth with spontaneous pain or sensitivity to percussion (signs of irreversible pulpitis).
- •Teeth with periodontal lesions, internal or external root resorption, calcified canals, mobility of tooth, sinus opening, or abscessed tooth.
- •Non restorable tooth.
- •Radiographic examination revealed, interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency.
- •Pulp bleeding that could not be controlled within 10 minutes using 2.5% sodium hypochlorite
- •Immune-compromised patients or with systemic medical disorders.
- •pregnant females
结局指标
主要结局
clinical success rate
时间窗: 1 year
pulp vitality by thermal pulp testing
次要结局
- radiographic assessment of incidence of regenerative dentin (dentin bridge)(1 year)
研究者
Rahma Ahmed Ibrahem Hafiz
assisstant lecturer- faculty of dentistry- beni suef university
Cairo University
研究点 (2)
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