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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.

Bone Regeneration Clinical Trial

Official title:
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.

Clinical Trial 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 indications. The primary objective is to evaluate the capacity of MimetikOss 3D to perform bone substitute requirements, i.e long-term regeneration of bony tissue in complex defects without detrimental resorption. The secondary main objectives are to assess the versatility of MimetikOss 3D by the variety of maxillofacial sites regenerated and the surgical technique improvement (in terms of surgery duration, blood loss, ease-of-use of the product and surgeon satisfaction).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04773847
Study type Interventional
Source Mimetis Biomaterials S.L.
Contact Emilie Thorel
Phone +33672121897
Email emilie.thorel@mimetis.es
Status Not yet recruiting
Phase N/A
Start date April 2021
Completion date October 2022
View Details
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