Horizontal defect length of jawbone =10cm
Conditions
Interventions
experimental group:Bio-Oss bone graft + 3D-printed WE43 magnesium alloy scaffold + WE43 magnesium alloy screws + collagen membrane
control group:Vascularized autologous bone + titanium plate + titanium screws
Sponsors
Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-65 years (inclusive), regardless of gender; 2.Jaw bone defect length >=10 cm; 3.Capable of understanding the trial objectives, voluntarily participating, and signing the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. Individuals allergic to magnesium or magnesium alloys; 2. Those known to be allergic to bovine or porcine-derived implants or who refuse them; 3. Patients requiring the use of autologous bone or other bone substitutes not provided in non-clinical trials; 4. Those with a history of head and neck radiotherapy or chemotherapy, currently undergoing such treatment, or planning to receive it; 5. Those currently receiving or within the past three months have received medications that may affect bone metabolism or have abnormal bone metabolism; 6. Patients with osteoporosis or osteomalacia; 7. Those with acute or chronic inflammation at the repair site; 8. Those with metal dentures, porcelain teeth, or other devices in adjacent teeth that could cause artifacts on imaging tests; 9. Smokers who average more than 5 cigarettes per day; 10. Alcoholics, drug addicts, or those addicted to other substances; 11. Individuals with severe cardiovascular or immunological disorders, serious blood diseases (such as leukemia); 12. Those with abnormal coagulation function or long-term use of anticoagulants (activated partial thromboplastin time, prothrombin time, thrombin time >= 1.5 times the upper limit of normal values); 13. Diabetic patients with fasting blood glucose >= 8.0mmol/L or systolic pressure >= 160mmHg and/or diastolic pressure = 100mmHg; 14. Those with liver or kidney dysfunction (aspartate aminotransferase, alanine aminotransferase, creatinine >= 1.5 times the upper limit of normal values); 15. Those with thyroid dysfunction; 16. Pregnant women, breastfeeding mothers, or those planning to become pregnant within 6 months; 17. Those who have participated in or are currently participating in other clinical trials within the past 3 months; 18. Those deemed unsuitable for inclusion by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgery success rate;Incidence of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Imaging new bone volume percentage; | — |
Countries
China
Contacts
Public ContactZhe Shao
Hospital of Stomatology, Wuhan University
Outcome results
None listed