3D printed bone grafts using BGS-7 for surgical reconstruction of zygomatic bone defect
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0002655
- Lead Sponsor
- Chung-Ang Univerisity Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
1. Adults who are over 19 years old and under 75 years old and have grown cheekbones
2. Those who have definite cheekbones defect and need reconstruction and want reconstruction
3. For women of childbearing age, those who agree to be contraceptive during the period of clinical trial participation (six months or more after surgery)
4. Those who voluntarily agree to participate in clinical trials and are willing to comply with the protocol
1. Those with uncontrolled metabolic disorders (eg diabetes, osteomalacia, thyroid disease)
2. Those who are taking or taking medications that can affect bone metabolism
? Bisphosphonate, Recombinant human parathyroid hormone (rhPTH), Denosumab, etc.
3. Those with uncontrolled gingivitis, periodontitis, or dental caries
4. Persons with severe heart disease or severe liver dysfunction
5. Persons with infectious diseases at risk of recurrence
6. Those with blood diseases (leukemia, hemophilia, sepsis, etc.)
7. Those who can not stop steroids, antithrombotics, and anticoagulants before surgery
8. Those who can not stop systemic corticosteroids or anabolic steroids for 3 months after surgery
9. People with osteomalacia and Paget's disease
10. Persons who have received radiation therapy at the surgical site
11. Allergic to implants
12. syphilis, severe epilepsy patient
13. People with substance abuse or alcoholism
14. Smokers
15. Who is currently pregnant or who has a pregnancy plan during the clinical trial
16. If the examiner determines that participation in the clinical trial is inadequate because it may affect other, ethical, or clinical trial results
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bone union rate / success rate of zygomatic bone
- Secondary Outcome Measures
Name Time Method Subject Satisfaction