Effect of Residual Dental Pulp Tissue and Cord Blood Stem Cells on Regeneration of Dental
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Regeneration of pulp
研究概览
简要总结
The experiments outlined in this proposal are designed to test the hypothesis that the in vivo injection of cord blood stem cells (InvitRx®) into the root canal system will facilitate teeth initially diagnosed with irreversible pulpitis, to form normal healthy pulpal tissue.
详细描述
Patients will be recruited from the various dental clinics at UCSF (student clinic, Advanced Education in General Dentistry clinic, post-graduate endodontics clinic, etc) that meet the inclusion and exclusion criteria. Patients in the control group will have root canal therapy initiated; instrumentation and cleaning up to 4mm from the radiographic apex. Bleeding will be induced and blood clot formed 3mm from the CEJ. MTA followed by glass ionomer and composite will be placed over the clot. Patients in the experimental group will have root canal therapy initiatied; instrumentation and cleaning up to 4mm from the radiographic apex. Bleeding will be induced and blood clot formed 3mm from the CEJ. 1 cc (30 million cord blood stem cells) will then be injected into the clot formation. MTA followed by glass ionomer and composite will be placed over the clot.
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 (Participant, Care Provider)
盲法说明
Syringe with the intervention and control will be covered with masking tape in order for both the provider and the participant to be blind.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A. Patients must be systemically healthy, Class I dental category. B. Involved teeth must have no periodontal disease detectible by periodontal examination.
- •C. Patients must present without radiographic signs of endodontic disease (i.e. no periapical radiolucencies).
排除标准
- •A. Presence of any disease or medication that alters the immune system or interferes with healing ability B. Smokers (more than 10 cigarettes per day) C. External or internal tooth resorption D. Tooth perforation from the pulp cavity through the tip of the root exposing the tissue to material in the oral cavity.
- •E. Pregnant or nursing mothers because hormonal factors may influence the condition.
- •F. Allergies or adverse reactions to local anesthetic medications G. Patients under the age of
- •H. Patients with an ASA Classification II or higher
结局指标
主要结局
Regeneration of pulp
时间窗: 6-9 months
Absence of clinical symptoms and signs as well as response to thermal testing.
次要结局
未报告次要终点