JPRN-jRCTb030190173已完成2 期
A clinical study for validity and provision method of periodontal tissue regeneration with autologous adipose derived stem cells and platelet rich plasma - Periodontal tissue regeneration using adipose derived stem cells and platelet rich plasma
Tobita Morikuni0 个研究点目标入组 15 人开始时间: 2020年1月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
This clinical study was accepted on March 15, 2019, and case enrollment began in March of the same year. Autologous ASCs and PRP transplantation or Emdogain transplantation was completed for all 15 patients in this study. The results suggest that ASCs and PRP transplantation has a certain degree of alveolar bone regeneration for periodontal tissue defect.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Have a Periodontal pocket more than 5 mm at baseline examination.
- •2. Intrabony defect is 5 mm and more depth, and 2 mm and more width at interproximal site of the experimental tooth by X-ray examination.
- •3. Already have received initial preparation at the screening.
- •4. Mobility of experimental tooth is 0, 1, or 2, and exist keratinized gingiva.
- •5. Good oral health.
- •6. Subcutaneous fat tissue can be harvest normally and safely
- •7. 20 years and older.
- •8. Signed informed consent.
排除标准
- •1. Can not be measured clinical attachment level of experimental tooth.
- •2. Have a history of Complicate malignant tumor.
- •3. Suspected of oral malignant tumor or precancerous lesion.
- •4. Need to undergo the treatment, such as surgical treatment, restorative treatment or root canal treatment, at the experimental tooth within 36 weeks after transplant.
- •5. Pregnancy, during breastfeeding, or possibility of pregnancy.
- •6. Have serious cardiac diseases.
- •7. Have serious liver diseases.
- •8. Have end-stage renal diseases or on hemodialysis.
- •9. Serious coagulopathies.
- •10. Hemoglobin A1c is more than 6.8% at the screening.
- •11. Have active infectious diseases.
- •12. Alcoholism or Drug dependence.
- •13. Mental or consciousness disorder.
- •14. HCV antibody, HBs antigen, ATLA virus antibody or HIV antibody positive person.
- •15. Smoke more than 10 pieces per day.
- •16. Other, the investigator believes makes him/her unsuitable for participation in the clinical study.
研究者
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