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ENROLLING BY INVITATION
NCT06773923
PHASE3

Effectiveness of 3D-printed Patient-specific Resorbable Scaffolds for Maxillary Bone Regeneration

Sponsor: Universidad Austral de Chile

View on ClinicalTrials.gov

Summary

The objective of this study is to test the bone formation capacity of a 3D printed scaffold with a plastic material called Polycaprolactone (PCL), compared to the use of synthetic bone grafts, for bone formation in the maxilla or mandible of elderly patients in the city of Valdivia between the years 2023-2024. The main beneficiaries will be patients, users of the public or private health system, who require bone regeneration. The intermediate beneficiaries are the health team: doctors specializing in surgery and orthopedics, dentists, maxillofacial surgeons, dedicated to bone reconstruction and regeneration. The innovation of this new material is based on the provision of a biocompatible plastic, easy to handle, for domestic 3D printing of bone matrices that can be grafted in areas requiring bone regeneration.

Official title: Effectiveness of Patient-specific 3D-printed Resorbable Scaffolds of Polycaprolactone, Beta-tricalcium Phosphate, and Metformin Used for Maxillary Bone Regeneration: Randomized Clinical Trial

Key Details

Gender

All

Age Range

30 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2024-07-01

Completion Date

2025-12-01

Last Updated

2025-01-15

Healthy Volunteers

Yes

Interventions

DEVICE

PCL Scaffold

patients with their jaw/maxilla in which the 3D scaffold with PCL will be inserted.

DEVICE

PTFE + Bio-Oss®

patients with jaw/maxilla which will be regenerated using the conventional technique using a titanium reinforced polytetrafluoroethylene (PTFE) membrane (Cytoplast® brand) and filling the space with Bio-Oss xenograft (Geistlich

Locations (1)

Valdivia

Valdivia, Chile