Clinical Study of Safety and Efficacy of Autologous Mesenchymal Stem Cells for Periodontal Tissue Regeneration Therapy
- Conditions
- Periodontal Disease
- Registration Number
- JPRN-jRCTb070230008
- Lead Sponsor
- Cho Yasushi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 22
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1) Probing Depth<br>(2) Presence of Serious Adverse Events
- Secondary Outcome Measures
Name Time Method (1) Plaque Adhesion<br>(2) X-Ray Examination