Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Assessment of pulp vitality
研究概览
简要总结
The aim of the present study is to assess clinically and radio-graphically the regenerative potential of immature permanent teeth with necrotic pulp using blood clot and Platelet rich fibrin scaffolds.
详细描述
30 immature necrotic permanent teeth in patients will be allocated and divided into two groups. Group 1 will be treated by regenerative procedure using blood clot as a scaffold and Group 2 will be treated with regenerative procedures using combined blood clot and Platelet rich fibrin as a scaffold.
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)
盲法说明
The radiographic specialist and the statistician will be blinded to treatment group
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Necrotic incisors with immature roots
- •Pulp space not needed for post and core.
- •The patient has to be free from any coagulation disorders, with normal platelets count.
- •Good oral hygiene
- •Cooperative patient
排除标准
- •Internal or external root resorption.
- •Root fracture and/or alveolar fracture.
- •Previous root canal treatment.
- •Medically compromised patients
- •Uncooperative patient
结局指标
主要结局
Assessment of pulp vitality
时间窗: 12 months
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
Subjective pain assessment
时间窗: 12 months
The patient will be asked about the presence of any pain or discomfort. Pain severity will be categorized as: no pain - mild pain - moderate pain - severe pain
Assessment of root development
时间窗: 12 months
Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
Assessment of the size of periapical radiolucency
时间窗: 12 months
Size of the lesion will be assessed using the periapical index (PAI) score. The PAI provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features).
次要结局
未报告次要终点
研究者
Nourhan M.Aly
Teaching Assistant of Dental Public Health and Statistician
University of Alexandria