periodontitis
Conditions
Interventions
Aspiration of abdominal adipose tissue Transplantation of adipose tissue-derived stem cells to the experimental site during periodontal surgery
Sponsors
Osaka University
Osaka University Hospital Medical Center for Translational Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Persons who have at least one periodontal pocket more than 7 mm at baseline examination. (2) Persons who have at least one intra-bony defect (4mm and more depth and 2mm and more width) at interproximal sites of the experimental tooth diagnosed by x-ray examination. (3) Persons who had received initial preparation at the time of screening for subjects. (4) Persons whose grade of mobility of experimental teeth is 0, 1 or 2 and whose width of keratinized gingiva is diagnosed to be appropriate for flap surgery. (5) Persons whose oral hygiene is established and who are judged to hold good compliance for oral hygiene methods instructed by the investigators after the transplantation of adipose tissue derived stem cells. (6) Persons who are older than 20 years old when obtained informed consents are obtained (7) Persons whose informed consents to join this study are obtained by the written document
Exclusion criteria
Exclusion criteria: (1) Persons whose clinical attachment level of experimental teeth cannot be measured. (2) Persons who have or have had malignant tumor. (3) Persons who are suspected to have malignant tumor or precancerous lesions at the oral cavity inspection before the registration. (4) Persons who have administered bisphosphonates, or are to administer the drug after the registration. (5) Persons who need to undergo the treatments, such as surgical treatment, restorative treatment or root canal treatment, which affect the experimental sites within 36 weeks after the transplantation of adipose tissue-derived stem cells. (6) Persons who are either pregnant, breast-feeding or possibly pregnant by the pregnancy test before the registration, or who hope to become pregnant within 36 weeks after the transplantation of adipose tissue-derived stem cells. (7) Persons who suffer from disorders of kidney, liver or blood. (8) Persons whose hemoglobinA1c is more than 6.5% in the blood test before the entry (9) Persons who suffer from active infectious diseases. (10) Persons who have the history of dependence on alcohol or drugs within 6 months before the registrarion. (11) Persons who suffer from mental or consciousness disorders. (12) Persons who have the positive reaction to the tests for hepatitis C virus antibody, hepatitis B virus antigen, human T-lymphotropic virus-1 antibody or human immunodeficiency virus antibody. (13) Persons who are judged not eligible for the subjects of this study by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence, severity, frequency and period of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Increase (%) in alveolar bone height Clinical attachment level (CAL) Probing pocket depth (PD) Bleeding on probing (BOP) Gingival index (GI) Tooth mobility | — |
Countries
Japan
Contacts
Public ContactMasahiro KITAMURA
Osaka University Graduate School of Dentistry Department of Periodontology, Division of Oral Biology and Disease Control
Outcome results
None listed