Regenerative medicine using bone marrow-derived mesenchymal cells for maxillomandibular bone defect.
- Conditions
- Bone defect resulting from maxillofacial injury, tumor/cyst removal in maxillomandibular regionr
- Registration Number
- JPRN-UMIN000020398
- Lead Sponsor
- agoya University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 4
Not provided
1. Patients with bone defect as a result of periodontitis 2. Patients for whom surgical procedure is prohibited e.g, severe heart disease, congenital coagulation factor deficiency, leukemia, dialysis, end-stage malignant tumor 3. Patients with or with a history of infection 4. Patients with diabetes that is not well-controlled 5. Patients taking bisphosphonates for more than 3 months or denosumab for more than 6 months before the consent 6. Patients with or with a history of malignant tumor 7. Patients taking steroids or immunosuppressive drugs who cannot stop such medication for 4 weeks after trial intervention 8. Patients in a serious condition of certain diseases 9. Patients with difficulty in bone marrow aspiration 10. Patients from whom a sufficient amount of blood cannot be taken for PRP preparation 11. Patients with contraindications to local anesthetics 12. Patients with a history of hypersensitivity to antibiotics, antifungals, thrombin products, or bovine blood-derived products 13. Patients taking hemocoagulase products, tranexamic acid products, or aprotinin products 14. Female patients who are pregnant, suspected to be pregnant, breastfeeding, or those who do not agree to practice contraception 15. Any other patients whom the trial investigator deemed ineligible to this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of procedure sites with successful bone regeneration
- Secondary Outcome Measures
Name Time Method 1)Regenerated bone height 2)Percentage of the regenerated bone height over the height of the initial defect 3)CT value 4)Rate of successful implant placement 5)Time from transplantation to implant placement 6)Survival rate and time of implant 7)Tooth mobility 8)Masticatory force 9)Histological assessment