NCT06773923Enrolling by invitationPhase 3
Effectiveness of 3D-printed Patient-specific Resorbable Scaffolds for Maxillary Bone Regeneration
Effectiveness of Patient-specific 3D-printed Resorbable Scaffolds of Polycaprolactone, Beta-tricalcium Phosphate, and Metformin Used for Maxillary Bone Regeneration: Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 15 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 7 Jan 2025
- Start date
- 1 Jul 2024
- Primary completion date
- 1 Mar 2025
- Lead sponsor
- Universidad Austral de Chile
- Diseases
- Osteoporosis
- NCT number
- NCT06773923
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 10
- From 1 Jul 2024 to the primary completion date, 1 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- patients had previous dental implant surgeries,
- patients taking any antiplatelet or anticoagulant drug,
Other illness
- diseases that produce acute/chronic pain,
- who suffer from any systemic disease whose surgical intervention is prohibited, for example: severe heart disease, congenital coagulation factor deficiency, dialysis, or malignant tumor in terminal phase,
- patients with a history of heart disease.
Lab values
- patients with diabetes that is not well controlled or who have difficulty achieving an Hb ≥ 7 g/dL in a preoperative examination,
Other
- with maxillary sinus pathologies or oral tissue lesions,
- smokers of more than 5 cigarettes per day,
- with excessive alcohol consumption (more than three times per week),
Who the study is looking for
- patients from the city of Valdivia, Chile, from Dental Health Service of the Base Hospital of Valdivia for the rehabilitation of their teeth with dental implants,
- age between 30 and 70 years old,
- regardless of sex,
- complete medical history (such as sex, age and comorbidities) will be recorded.
- patients requiring bone regeneration at the time of examination should have an atrophic bilateral mandible with poor bone available according to periodontal deseases classification behind tooth #3.3 or #4.3; with an edentulous alveolar ridge with a remaining bone height of ≤ 6 mm.
Age in the registry: 30 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Valdivia Coordinator of this site? Confirm its status | Valdivia | Chile | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.