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

January 13, 2025 updated by: Pedro C Aravena, Universidad Austral de Chile

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

A parallel-arm randomized clinical trial will be designed. The participants will be elderly patients from the city of Valdivia, Chile, regardless of sex, from the Dental Health Service of the Base Hospital of Valdivia for dental rehabilitation with dental implants. Clinical characteristics and complete medical history (such as sex, age and comorbidities) will be recorded and all the information that allows the identification of the patients will be encrypted.

Patients requiring bone regeneration at the time of examination should have an atrophic bilateral mandible with poor bone available according to periodontal diseases classification behind tooth #3.3 or #4.3; with an edentulous alveolar ridge with a remaining bone height of ≤ 6 mm. Patients will be excluded if they have had previous dental implant surgeries, with maxillary sinus pathologies, with oral tissue lesions, diseases that produce acute/chronic pain, smokers of more than 5 cigarettes per day, with excessive alcohol consumption (more than three times per week), and 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. Also excluded are patients with diabetes that is not well controlled or who have difficulty achieving an Hb ≥ 7 g/dL in a preoperative examination; patients taking any anti-platelet or anticoagulant drug and patients with a history of heart disease.

- Sample size calculation Considering as the main objective of this study the formation of vital and functional bone analyzed in histological specimens, for the sample calculation the researcher relied on the previously randomized clinical trial who demonstrated a difference in the percentage of bone formation using PCL bone matrices in bone preservation was 9.5%. As a result of using this effect size with a given alpha level of 0.05, a power of 80% and an allocation ratio of 1, the sample size was 4 patients per group (algorithm: mean power 1 9.5, sd(3.6). STATA v.14.0..

Furthermore, taking into account that each patient will use both sides of their jaw (left and right), with two study groups and a 25% loss to follow-up or sample processing error, estimating that a total of 10 patients will participate in this study.

  • Study groups and randomization

    • Osteoprint group: Patients with a jaw/maxilla atrophy in which the 3D scaffold with PCL will be inserted.
    • Control group: Patients with a jaw/maxilla atrophy 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 Pharma Agency. Germany).
  • Randomization: The mechanism to perform the randomization sequence will be using the "RANDBETWEEN" function of Microsoft Excel® v.15.24.2016 (Microsoft, Sacramento. USA). An researcher will randomize in a spreadsheet with three columns: the first column with the patient number, the second column with the maxilla/mandible side to be used (#1 right side; #2 left side) and the third column with the type of study group to be used (#1: experimental group; #2: control group). This sequence will be previously determined by an investigator and will be informed before surgery, according to the number of patients to be operated.
  • Experimental Design To analyze the osteogenic capacity of the 3D printed bone scaffold with PCL, an researcher will compare the volume of bone formed in the area using the 3D printed bone scaffold with PCL+ βTCP (experimental group) versus the volume of bone regenerated using a titanium-reinforced polytetrafluoroethylene (PTFE) membrane (control group). The outcome will be measured in histomorphometry and immunohistochemistry of bone biopsies obtained at six months.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Valdivia, Chile, 5110434
        • Valdivia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • patients had previous dental implant surgeries,
  • with maxillary sinus pathologies or oral tissue lesions,
  • diseases that produce acute/chronic pain,
  • smokers of more than 5 cigarettes per day,
  • with excessive alcohol consumption (more than three times per week),
  • 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 diabetes that is not well controlled or who have difficulty achieving an Hb ≥ 7 g/dL in a preoperative examination,
  • patients taking any antiplatelet or anticoagulant drug,
  • patients with a history of heart disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Osteoprint group
Patients with of their jaw/jawbone in which the 3D scaffold printed with PCL will be inserted.
Device: PCL Scaffold
patients with their jaw/maxilla in which the 3D scaffold with PCL will be inserted.
Active Comparator: Control group
Patients with of their jaw/mandible 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 Pharma AG. Germany).
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histology: area new bone tissue
Time Frame: 6 months
Bone biopsies obtained during implant installation surgery will be used. Once mounted on slides and stained with hematoxylin-eosin (H&E) and immunohistochemical markers, they will show the presence of vital bone as bone tissue with osteocyte lacunae, soft connective tissue and blood vessels. The amount of new bone tissue will be quantified as the percentage of area encompassed by the new bone sample versus the field of view observed under the light microscope at 40X magnification.
6 months
Biomarkers
Time Frame: 6 months
In bone biopsies with inmunohistochemistry markers, optical densities of interferon-α, IL-1β, interleukin -10 t Runx-2 positive stains as percentage of the total area observed in the microscope field will be registered.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Health Quality of life.
Time Frame: 6 months
All patients will be given the "Health-related quality of life (HRQOL) scale in its Spanish version 'HRQOL-sp'. The scale evaluates symptoms, psychological aspects and oral function. This instrument is specifically used to measure patients' perception after surgery in four domains (oral function, general activity, signs and symptoms, and pain) and the recording of postoperative associated signs or symptoms, complications and pain level measured by the Verbal Rating Scale (VRS). The patients will be choice between four Likert scale alternatives: "no problems", "little problems", "quite a lot of problems" and "many problems".
6 months
Postoperative complications
Time Frame: 6 months
The presence of dichotomous (yes/no) signs of: swelling, ecchymosis, bleeding, nausea, vomiting, fever will be quantified.
6 months
Level of pain
Time Frame: 6 months
The level of pain felt during the follow-up between 1st to 14th day will be measured with a visual analog scale from 0 (no pain) to 10 points (worst pain imaginable).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Austral de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Osteoprint_2025
  • 23IRLR-249819 (Other Grant/Funding Number: Innova CORFO. Government of Chile)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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