Feasibility study of periodontal tissue regene ration using the combination of adipose-derived stem cells, platelet-rich plasma and autologous bone transplantation

未提供0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年2月29日

试验速览

阶段: 不适用
状态: 已完成
入组人数: 10
主要终点: -

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Single Arm Study
干预模型: Single Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 20age old over 至 No limit（—）
性别: All

入选标准

•(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.

排除标准

•(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.

结局指标

主要结局

Safety

次要结局

Serious adverse events in the target disease
Serious defects in the final cell product
Height of new alveolar bone at the transplantsite (dental radiograph)
Height of new alveolar bone at the transplantsite (CBCT)
Periodontal histology (attachment level, probing, degree of tooth movement, gingival bleeding during probing, gingivitis index)

研究者

发起方

未提供

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