Incomplete load-bearing bone defects in oral and maxillofacial regions
Conditions
Interventions
Experimental group:absorbable bone-repairing material by additive manufacturing
Control group: bone filling material of Geistlich Bio-Oss
Sponsors
Huashan Hospital affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 68 Years
Inclusion criteria
Inclusion criteria: 1, 18 years old = age =75 years old, gender is not limited; 2. Maxillofacial bone defect restorers: oral and maxillofacial bone defects are not completely load-bearing; 3. Subjects voluntarily participate in clinical trials and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Participated in other clinical trials within 4 weeks before the start of this trial; 2. For stomatological indications: A. The longest end of the jaw cyst is more than 2cm; b. No teeth on both sides of the extraction site or abnormal teeth. c. The alveolar bone height at the extraction site is not sufficient, or bone increment surgery has been received, such as maxillary sinus lift. d. Subjects whose surgical sites may produce artifacts due to various conditions caused by CT examination, such as metal dentures and porcelain teeth; e, a large number of smokers, smoking more than 5 cigarettes per day in the past three months; 3. Various bone defects caused by invasive and malignant bone tumors; 4. Patients who are undergoing tumor treatment, have a history of radiotherapy or chemotherapy, or are receiving immunosuppressive therapy; 5. Patients who are receiving or have received within the last 3 months drugs that may affect or promote bone metabolism; Systemic diseases that may affect surgical wound healing, such as bone marrow inflammation, osteochondrosis, and bone metabolic diseases; 6. Patients with severe cardiovascular, pulmonary, or other systemic diseases that researchers believe cannot tolerate surgery, such as heart insufficiency (New York Heart Function Scale II or higher); 7, have serious liver and kidney disease or abnormal liver and kidney function (ALT, AST > 2.5 times the normal value, creatinine > 2 times the normal value; Abnormal blood calcium and phosphorus results); 8. Poorly controlled diabetic patients (fasting blood glucose still =8.0mmol/L after drug control); 9. Severely obese patients (BMI=40kg/m2); 10. Known autoimmune disease; 11, long-term adrenal corticosteroid therapy; 12, mental abnormality without behavioral autonomy; 13. Patients with allergic constitution to polymer materials; 14, pregnant, lactating or menstruating women, or people with pregnancy plans within six months; 15. Other conditions that the researcher determines cannot participate in the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone fusion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound healing;Site retention rate;Orbital floor repair rate;Product performance satisfaction; | — |
Countries
China
Contacts
Public ContactXiongzheng Mu
Huashan Hospital affiliated to Fudan University
Outcome results
None listed