Bone regeneration of 3D printed customized ceramic scaffold with PDRN(Polydeoxyribonucleotide): clinical trial
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0009145
- Lead Sponsor
- Hallym University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 6
1) Patients over 20 years of age who has completed the skeletal growth
2) Patients with bone loss after removal of severe atrophy of alveolar ridge and cyst
3) If the patient is a non-smoker or smokes less than 1 pack (20 cigarettes) per day
4) Patients who voluntarily decided to participate in this clinical trial and agreed to the consent form of the subject in writing.
1) Patients who are pregnant
2) Patients who have metabolic diseases (uncontrolled diabetes, etc.)
3) Patients taking drugs that can affect bone metabolism – bisphosphonates, rhPTH, denosumab, etc.
4) Patients with uncontrolled gingivitis, periodontitis, or dental caries
5) Patients who have received radiation therapy in the treatment area
6) Patients with the hemorrhagic disease or need to take anticoagulants
7) Patients allergic to bone graft/implant materials
8) If the patient smokes more than 1 pack (20 cigarettes) per day
9) Other improper patients who are thought to be inappropriate for participation due to the ethical issue, or because it may affect the results of the clinical trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the stability of the grafted bone material
- Secondary Outcome Measures
Name Time Method Verification of the clinical safety/efficacy, assessment of the abnormal response, evaluation of the new bone through Micro CT analysis