JPRN-jRCTb030220370SuspendedPhase 2
Feasibility study of periodontal tissue regene ration using the combination of adipose-derived stem cells, platelet-rich plasma and autologous bone transplantation
Tobita Morikuni0 sites10 target enrollmentStarted: October 7, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Suspended
- Sponsor
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •(1) Teeth that have been diagnosed with marginal periodontitis andthe dentist has determined that flap surgery is necessary.
- •(2) Vertical bone defects with a probing depth of 6 mm or more and adepth of 5 mm or more are found in the mesial or distal side of thetarget tooth.
- •(3) Teeth with keratinized gingivadetermined to be suitable for flapsurgery with a tooth mobility of 2 degrees or less.
- •(4) Patients who are capable of oral hygienemanagement.
- •(5) Must be able to perform normal subcutaneous fat tissue sampling.
- •(6) 20 years of age or older at the time of obtaining consent.
- •(7) Patients who have consented in writing to participate in thisclinical trial.
Exclusion Criteria
- •(1) Teeth for which it is impossible to measure the clinical attachmentlevel
- •(2) Patients with concomitant or history of malignancy
- •(3) Patients with malignant tumors, allcancerous lesions, or suspiciousfindings in the pre-registration oral examination
- •(4) Patients who have been diagnosed with osteoporosis.
- •(5) Teeth with concomitant diseases other than marginal periodontitisthat may affect periodontal tissue regeneration therapy (periodontitis,root fracture, etc.)
- •(6) Tooth that is scheduled to undergo a procedure (surgical treatment,prosthetic treatment, root canal treatment, etc.) that may affect theevaluation of the implantation site within 36 weeks after implantation
- •(7) Pregnant, lactating, possibly pregnant according to a pregnancytest prior to enrollment, or planning to become pregnant within 36weeks of implantation
- •(8) Patients with serious hematological diseases or abnormal bonemetabolism
- •(9) Patients with abnormalities in the kidney, digestive organs, orother organs of calcium metabolism, or suspected collagen disease.
- •(10) Patients on dialysis or receiving steroids.
- •(11) Patients with unmanageable complications that limit compliancewith clinical research requirements, such as serious complications (e.g.,serious heart disease, liver disease) or psychiatric disorders.
- •(12) Patients with a blood hemoglobin A1c of 6.8% or higher prior toenrollment
- •(13) Patients with active infections
- •(14) Patients with a history of alcohol ordrug intoxication
- •(15) Those who are positive for HCV antibody, HBs antigen, ATLAvirus antibody, or HIV antibody
- •(16) Smokers (average of 10 cigarettes/day or more)
- •(17) Those who, in the judgment of the principal investigator, areconsidered inappropriateto participate in this research.
Investigators
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