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Safety study of periodontal tissue regeneration using the combination of adipose-derived stem cells, platelet-rich plasma and autologous bone transplantation (Safety study of periodontal tissue regeneration using the combination of adipose-derived stem cells, platelet-rich plasma and autologous bone transplantation )

Safety study of periodontal tissue regeneration using the combination of adipose-derived stem cells, platelet-rich plasma and autologous bone transplantation (Safety study of periodontal tissue regeneration using the combination of adipose-derived stem cells, platelet-rich plasma and autologous bone transplantation)

Yamaji Ken

Tobita Morikuni

Juntendo University

2-1-1Hongo,Bunkyou-ku,Tokyo,Japan

mtobita@juntendo.ac.jp

Nagai Shigeru

Juntendo University

2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan

+81-3-3813-3111

s.nagai.ul@juntendo.ac.jp

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(1) Those who have completed basic periodontal treatment by the time of transplantation
(2) Persons who have determined that it is possible to collect adipose tissue normally and safely.
(3) Persons who are 18 years of age or older at the time of obtaining consent
(4) Persons who have given written consent to participate in this clinical research
(5) When considering alveolar bone regeneration for vertical bone defects due to chronic periodontitis, those who have a periodontal pocket with a probing depth of 5 mm or more on one or more consecutive teeth after basic periodontal treatment.
(6) When considering alveolar bone regeneration for vertical bone defects due to chronic periodontitis, those whose vertical bone defects with a depth of 5 mm or more and a width of 2 mm or more are found in the interdental region by X-ray examination.
(7) When considering alveolar bone regeneration for vertical bone defects due to chronic periodontitis, subjects with a degree of tooth mobility of 2 degrees or less and keratinized gingiva for which flap surgery is considered appropriate.
(8) When considering alveolar bone regeneration or socket preservation during dental implant treatment for tooth loss accompanied by alveolar bone atrophy, there is insufficient alveolar bone volume for dental implant insertion, and alveolar bone regeneration is insufficient. Patients deemed necessary

(1) Persons with malignant tumor or a history of malignant tumor less than 5 years prior to registration
(2) Persons who have malignant tumor, precancerous lesion, or findings suspected of these in pre-registration oral diagnosis
(3) Patients who have used or need to use bisphosphonate drugs
(4) Persons who are pregnant, may become pregnant, or wish to become pregnant
(5) Persons with serious complications such as kidney disorder, liver disorder, heart disease, or blood disorder.
(6) Persons who have been diagnosed with diabetes and whose doctor has determined that they cannot medically control their blood sugar.
(7) Patients who have been diagnosed with hypertension and whose blood pressure has been determined by a doctor to be medically uncontrollable.
(8) Persons with unstable angina, myocardial infarction, cerebral infarction, cerebral hemorrhage, or transient ischemic attack less than 3 months after onset
(9) Persons with comorbid mental illness
(10) Persons who currently smoke
(11) Any other person whose participation in this research is considered inappropriate according to the judgment of the implementation director.

Both

Chronic periodontitis with moderate or more severe vertical bone defects .Tooth loss with alveolar

Collection of subcutaneous adipose tissue and blood, implantation of adipose-derived stem cells

Safety

Amount of change in the height of the alveolar bone in the transplanted area based on dental X-ray standard photographic images (evaluation period: 3 months after transplantation and post-observation period (6 months and 9 months after transplantation)).
Amount of change in alveolar bone height in the transplanted area due to increased dental CBCT imaging (evaluation period: 3 months after transplantation and post-observation period (9 months after transplantation)).
Periodontal tissue examination (3 months after transplantation, follow-up period (6 and 9 months after transplantation)).

Not Recruiting

+81-533-66-2226

July. 05, 2024