Bone defect resulting from maxillofacial injury, tumor/cyst removal in maxillomandibular regionr
Conditions
Interventions
Transplantation of bone marrow-derived mesenchymal cells, platelet rich plasma, thrombin, calcium chloride and beta-TCP.
Transplantation of platelet rich plasma, thrombin, calcium chloride and beta-TC
Sponsors
Nagoya University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients who require bone regeneration satisfying all of the inclusion criteria below: >=20-year-old patients who have a maxillomandibular bone defect that lies over 1/3 of the maxillomandibular area with remaining bone of <=10 mm in height due to maxillofacial injury or tumor/cyst removal (Patients who had surgical tumor removal in maxillomandibular region must not have relapse/metastasis for 5 year of observation period after the procedure) 2.Patients who have received plaque control instructions by a dentist or a dental hygienist and are in a good management of it 3.Patients who are willing and able to give signed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of procedure sites with successful bone regeneration | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactShinobu Shimizu
Nagoya University Hospital Department of Advanced Medicine
Outcome results
None listed