Feasibility Study of Periodontal Tissue Regeneration Using Adipose Stem Cells, Platelet Plasma, and Autologous Bone

Phase 2

Suspended

• Conditions: Marginal periodontitis

• Registration Number: JPRN-jRCTb030220370
• Lead Sponsor: Tobita Morikuni

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety

Secondary Outcome Measures

Name	Time	Method
1. Evaluation of safety<br>1) Serious adverse events in the target disease<br>2) Serious defects in the final cell product<br>2. Evaluation of efficacy<br>1) Height of new alveolar bone at the transplantsite (dental radiograph)<br>2) Height of new alveolar bone at the transplantsite (CBCT)<br>3) Periodontal histology (attachment level, probing,degree of tooth movement, gingival bleeding duringprobing, gingivitis index).