A Single-arm Clinical Trial Evaluating the Efficacy and Safety of Pulp Regeneration Induced by SHED Polymerization in Patients With Pulp Necrosis of Permanent Teeth
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Assessment of pulp vitality
研究概览
简要总结
Dental pulp necrosis is one of the most common pathological conditions that results in tooth loss. However, regeneration of functional dental pulp has proved difficult. Therefore, the investigators conduct a single-arm study to evaluate the efficacy and safety of pulp regeneration induced by SHED mixed with hyaluronic acid polymerization in patients with pulp necrosis of permanent teeth.
详细描述
This study is a single-center, prospective, single-arm study to evaluate the efficacy and safety of pulp regeneration induced by SHED mixed with hyaluronic acid polymerization in patients with pulp necrosis of permanent teeth. This study plans to include 30 subjects from the Department of Stomatology of the Fifth Affiliated Hospital of Guangzhou Medical University. All participants in this study will receive stem cells from human exfoliated deciduous teeth (SHED) mixed with hyaluronic acid polymers after the preparation and disinfection of the root canal of the affected teeth. All participants will undergo screening and baseline visits. After surgery, the participants will be followed up for 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 to 45 years
- •Patients with pulp necrosis of a single canal permanent tooth due to trauma or caries
- •Patients who have signed informed consent
排除标准
- •Patients with pulp necrosis caused by severe trauma to the tooth, such as crown root fracture, tooth root fracture, tooth displacement, etc
- •Patients with calcification of the apical foramen at the root of the tooth
- •History of hereditary disorders of abnormal tooth development
- •Dental occlusal trauma, bruxism, malocclusion
- •Bad oral habits (sticking out the tongue, biting lips, biting nails, sucking fingers, etc.)
- •Presence of uncontrollable pathological processes in the oral cavity (presence of acute advanced diseases in the oral cavity)
- •Malnutrition (serum albumin concentration<2 g/dl)
- •Patients with history of other systemic, communicable or hereditary diseases have been diagnosed
- •Pregnant, nursing, planning to become pregnant
- •The investigators determined that the patient was not suitable for the study
研究组 & 干预措施
single-arm
干预措施: Allogeneic human pulp mesenchymal stem cells mixed with hyaluronic acid polymers (Drug)
结局指标
主要结局
Assessment of pulp vitality
时间窗: 1、3、6、12、18、24 months
Change in pulpal vitality will be assessed through pulpal response to sensitivity tests (cold, hot and electrical test) in affected tooth.
次要结局
- Blood flow in the root of tooth(1、3、6、12、18、24 months)
研究者
Xueli Mao
Chief physician
Fifth Affiliated Hospital of Guangzhou Medical University