jRCTb070230008暂停不适用
Clinical Study of Safety and Efficacy of Autologous Mesenchymal Stem Cells for Periodontal Tissue Regeneration Therapy
未提供0 个研究点目标入组 22 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 22
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age 0month 0week old over 至 80age 0month 0week old not（—）
- 性别
- All
入选标准
- •Those who meet all of the following criteria will be considered research subjects for this clinical study.
- •(1) Those who is more than 20 years and less than 80 years.
- •(2) Those who have recieved sufficient explanation using ICF and understand the contents, and who have obtained written consent to participate in clinical study based on their free will.
- •(3) Those who do not show improvement of periodontal symptoms after basic periodontal treatment.
- •(4) Those who have recieved sufficient explanation about periodontal surgical treatment and understand the details of the treatment, and refuses to undergo periodontal surgical treatment of their own free will.
- •(5) Those who have periodontal pockets with probing depth of 4 mm or greater on one tooth or multiple contiguous teeth after basic periodontal therapy.
- •(6) Those who are found to be bleeding after 30 seconds of the probing test.
- •(7) Those who have more than 1 degree of tooth mobility in one tooth or multiple contiguous teeth.
- •(8) Those who do not have apical periodontitis or a neoplasm (e.g., malignant tumor) that destroys periodontal tissue.
- •(9) Those who have the will and ability to visit the clinic until the expiration of the observation period.
排除标准
- •Those who meet even one of the following criteria will be excluded from this clinical study.
- •(1) Those who have experienced hypersensitivity or allergic reactions to anesthetics used during tissue collection or to substances used in the manufacturing process.
- •(2) Those who has infectious diseases (HIV, HBV, HCV, HTLV-1, Syphilis).
- •(3) Those who have diabetes mellitus, chronic pain, severe cardiopulmonary disease, thrombosis, brain tumor or cancer of other organs.
- •(4) Pregnant women, lactating women, and women who may be pregnant.
- •(5) Other persons deemed inappropriate by dentists.
结局指标
主要结局
-
(1) Probing Depth (2) Presence of Serious Adverse Events
次要结局
未报告次要终点
研究者
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