JPRN-jRCTb070230008
Recruiting
未知
Clinical Study of Safety and Efficacy of Autologous Mesenchymal Stem Cells for Periodontal Tissue Regeneration Therapy
Cho Yasushi0 sites22 target enrollmentApril 17, 2023
ConditionsPeriodontal Disease
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Periodontal Disease
- Sponsor
- Cho Yasushi
- Enrollment
- 22
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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