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

NCT06773923 | Enrolling By Invitation Phase 3 FDA Device

• 2 other identifiers: Osteoprint_202523IRLR-249819
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Polycaprolactone; Scaffold; Bone regeneration; Printing, three dimensional; Dentistry; Clinical Trial

Outcome Measures

Primary Outcomes (2)

• Histology: area new bone tissue

  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

  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 Outcomes (3)

• Oral Health Quality of life.

  6 months

• Postoperative complications

  6 months

• Level of pain

  6 months

Study Arms (2)

Osteoprint group

EXPERIMENTAL

Patients with of their jaw/jawbone in which the 3D scaffold printed with PCL will be inserted.

Device: PCL Scaffold

Control group

ACTIVE COMPARATOR

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®

Interventions

PCL Scaffold DEVICE

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

Osteoprint group

PTFE + Bio-Oss® DEVICE

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

Control group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Austral de Chile: lead

Study Sites (1)

Valdivia

Valdivia, 5110434, Chile

Location

Related Publications (9)

• Dalfino S, Olaret E, Piazzoni M, Savadori P, Stancu I, Tartaglia G, Dolci C, Moroni L. Polycaprolactone/beta-Tricalcium Phosphate Composite Scaffolds with Advanced Pore Geometries Promote Human Mesenchymal Stromal Cells' Osteogenic Differentiation. Tissue Eng Part A. 2025 Jan;31(1-2):13-28. doi: 10.1089/ten.TEA.2024.0030. Epub 2024 Apr 30.

  PMID: 38613813 BACKGROUND

• Rai B, Lin JL, Lim ZX, Guldberg RE, Hutmacher DW, Cool SM. Differences between in vitro viability and differentiation and in vivo bone-forming efficacy of human mesenchymal stem cells cultured on PCL-TCP scaffolds. Biomaterials. 2010 Nov;31(31):7960-70. doi: 10.1016/j.biomaterials.2010.07.001. Epub 2010 Aug 4.

  PMID: 20688388 BACKGROUND

• Park H, Kim JS, Oh EJ, Kim TJ, Kim HM, Shim JH, Yoon WS, Huh JB, Moon SH, Kang SS, Chung HY. Effects of three-dimensionally printed polycaprolactone/beta-tricalcium phosphate scaffold on osteogenic differentiation of adipose tissue- and bone marrow-derived stem cells. Arch Craniofac Surg. 2018 Sep;19(3):181-189. doi: 10.7181/acfs.2018.01879. Epub 2018 Sep 20.

  PMID: 30282427 BACKGROUND

• Safiaghdam H, Nokhbatolfoghahaei H, Farzad-Mohajeri S, Dehghan MM, Farajpour H, Aminianfar H, Bakhtiari Z, Jabbari Fakhr M, Hosseinzadeh S, Khojasteh A. 3D-printed MgO nanoparticle loaded polycaprolactone beta-tricalcium phosphate composite scaffold for bone tissue engineering applications: In-vitro and in-vivo evaluation. J Biomed Mater Res A. 2023 Mar;111(3):322-339. doi: 10.1002/jbm.a.37465. Epub 2022 Nov 5.

  PMID: 36334300 BACKGROUND

• Rodrigues MT, Martins A, Dias IR, Viegas CA, Neves NM, Gomes ME, Reis RL. Synergistic effect of scaffold composition and dynamic culturing environment in multilayered systems for bone tissue engineering. J Tissue Eng Regen Med. 2012 Nov;6(10):e24-30. doi: 10.1002/term.499. Epub 2012 Mar 27.

  PMID: 22451140 BACKGROUND

• Ivanovski S, Breik O, Carluccio D, Alayan J, Staples R, Vaquette C. 3D printing for bone regeneration: challenges and opportunities for achieving predictability. Periodontol 2000. 2023 Oct;93(1):358-384. doi: 10.1111/prd.12525. Epub 2023 Oct 12.

  PMID: 37823472 BACKGROUND

• Obregon F, Vaquette C, Ivanovski S, Hutmacher DW, Bertassoni LE. Three-Dimensional Bioprinting for Regenerative Dentistry and Craniofacial Tissue Engineering. J Dent Res. 2015 Sep;94(9 Suppl):143S-52S. doi: 10.1177/0022034515588885. Epub 2015 Jun 29.

  PMID: 26124216 BACKGROUND

• Ivanovski S, Staples R, Arora H, Vaquette C, Alayan J. Alveolar bone regeneration using a 3D-printed patient-specific resorbable scaffold for dental implant placement: A case report. Clin Oral Implants Res. 2024 Dec;35(12):1655-1668. doi: 10.1111/clr.14340. Epub 2024 Aug 7.

  PMID: 39109582 BACKGROUND

• Park JY, Jeon SH, Lee JY, Park JM, Cha JK. Vertical and Horizontal Ridge Augmentation Using Customized Three-Dimensionally Printed Polycaprolactone Mesh in Atrophic Posterior Maxillae: A Case Report. J Oral Implantol. 2025 Aug 8;51(4):326-336. doi: 10.1563/aaid-joi-D-22-00007.

  PMID: 36796059 BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic; Jaw, Edentulous; Mouth, Edentulous; Jaw Fractures; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Jaw Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, PhD, Dental Implant and Periodontal Plastic Surgery Specialist

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 14, 2025
• Study Start: July 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)