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

NCT06773923 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-01-15

No results posted yet for this study

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.

Conditions

  • Bone Loss
  • Jaw, Edentulous
  • Edentulous Mouth
  • Jaw Fractures
  • Bone Loss, Age Related

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

Sponsors & Collaborators

  • Universidad Austral de Chile

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-03-01
Completion
2025-12-01
FDA Device
Yes

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06773923 on ClinicalTrials.gov