NCT04773847

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Mimetis Biomaterials S.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Bone Regeneration

Interventions

Type	Name	Description
PROCEDURE	Surgical reconstruction of maxillofacial osseous defect with MimetikOss 3D.	Surgical reconstruction of maxillofacial osseous defect with MimetikOss 3D.

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-04-01
• Completion: 2022-10-01
• First posted: 2021-02-26
• Last updated: 2021-02-26