None listed
Conditions
Interventions
Medical Device : Orthopedic product PRIMARY-M (A medical device used to replace or support bone defects in the mandible and cheekbones. It is a custom implant manufactured using a 3D printer, which is
s medical image to identify patient'
s bone shape and predicts the expected bone defect for customization.
Sponsors
CusMedi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) patients 7 years of age or older (2) Patients who require jaw bone reconstruction after excision of jaw bone due to oral cancer or jaw necrosis (3) Patients with orthognathic surgery planned for maxillofacial malformations (4) Orthodontic treatment using bone fixation miniplate due to malocclusion (5) Patients requiring reduction and reconstruction of facial bone fractures due to maxillofacial trauma (6) Patients who have consented to participate in the clinical trial and signed the subject consent form
Exclusion criteria
Exclusion criteria: (1) pregnant women (2) patients with metabolic disease (uncontrolled diabetes, etc.) (3) Patients with allergies to implants and sheet metal materials (4) Patients with uncontrolled gingivitis, periodontitis and dental caries (5) Patients who have received radiation treatment at the treatment site (6) patients with hemorrhagic disease or need anticoagulant (7) The investigator judges that participation in the clinical trial is inappropriate because it may affect the results of other clinical studies or ethics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure the accuracy of the surgery;Evaluation of Intraosseous Stability of Titanium Implants;Measure efficiency of surgery;Safety evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the impact of MRI | — |
Countries
Korea, Republic of
Contacts
Public ContactSUNHYUN KIM
Ewha Womans University
Outcome results
None listed