Status:
UNKNOWN
The Clinical and Radiographic Outcomes of a 3D-printed Patient-specific Biomimetic Bone Substitute in Maxillofacial Indications: an Interventional, Multi-centred, Open-label, Post-market Clinical Investigation.
Lead Sponsor:
Mimetis Biomaterials S.L.
Conditions:
Bone Regeneration
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the study is to evaluate the clinical and radiographic outcome of MimetikOss 3D as a patient-specific bone substitute in regeneration of osseous defects in several maxillofacial indicat...
Eligibility Criteria
Inclusion
- Male or female age 18 years or over at the time of inclusion into the study;
- Ability to obtain written informed consent from the recipient;
- Patients in need of craniomaxillofacial bone regeneration;
- Ability and capacity to comply with the procedures described in the protocol, including responding to simple questionnaires either by the recipient in person or by a next relative (spouse, parent) who lives with the recipient;
- Patients with good general hygiene;
- Radiographic exam allowing a complete observation of the osseous defect;
- Mimetis approval of the feasibility.
Exclusion
- Active tumour;
- Passive tumour with cancer recurrence within 10 years;
- Practice of intensive contact sport exercise during the clinical trial duration;
- Concomitant participation in other clinical trials;
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study;
- Women who are breastfeeding;
- Alcohol or drug abuse as noted in subject records or in subject history;
- Patients with a medical condition that may compromise the healing process or history of systemic diseases that would contraindicate the surgical treatment or any other disease that might have an influence on the involved tissues, such as: severe metabolic disorders, osteogenesis imperfecta, osteoporosis, infectious and degenerative bone diseases, immunodeficiency (congenital or acquired), autoimmune disease, Osler-Weber-Rendu syndrome, unbalanced diabetes, transient hypercalcemia, allergic disposition to phosphate calcium components, titanium or collagen etc; immunosuppressive therapy, steroid therapy, heparin treatment, corticoid treatment, treatments that interfere in the calcium-phosphate metabolism, bisphosphonate intake, Paclitaxel treatment, methotrexate medication etc);
- Acute and chronic infections in the surgery area (e.g. soft tissue infections, inflammatory and bacterial osteopathy, osteomyelitis) and / or mucosal diseases in the areas to be treated;
- In case of intraoral surgery, heavy smokers (\>10 cigarettes) excluded;
- Inability to return for follow up visits.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04773847
Start Date
April 1 2021
End Date
October 1 2022
Last Update
February 26 2021
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