A clinical study for validity and provision method of periodontal tissue regeneration with autologous adipose derived stem cells and platelet rich plasma
- Conditions
- periodontitis
- Registration Number
- JPRN-jRCTb030190173
- Lead Sponsor
- Tobita Morikuni
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 15
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy
- Secondary Outcome Measures
Name Time Method Safety