Bone LossPhase 3OSTEOPRINTNCT06773923
Effectiveness of 3D-printed Patient-specific Resorbable Scaffolds for Maxillary Bone Regeneration
A Phase 3 study testing PCL Scaffold and PTFE + Bio-Oss® in people with Bone Loss and Jaw, Edentulous, run by Universidad Austral de Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Jaw, Edentulous, Edentulous Mouth
- What is being tested?
- PCL Scaffold and PTFE + Bio-Oss®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChile
- Study dates
- 1 Jul 2024to 1 Dec 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Being tested
- PCL Scaffold, PTFE + Bio-Oss®
- Keywords
- Polycaprolactone, Scaffold, Bone regeneration, Printing, three dimensional, Dentistry, Clinical Trial
- Medical subject headings
- Bone Diseases, Metabolic, Jaw, Edentulous, Mouth, Edentulous, Jaw Fractures, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCL ScaffoldDevice
patients with their jaw/maxilla in which the 3D scaffold with PCL will be inserted.
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
| Study group | Role | What they receive |
|---|---|---|
| Osteoprint group | Experimental | Patients with of their jaw/jawbone in which the 3D scaffold printed with PCL will be inserted. Receives: 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). Receives: Device: PTFE + Bio-Oss® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (3)
Oral Health Quality of life.
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".
Measured: 6 months
Postoperative complications
The presence of dichotomous (yes/no) signs of: swelling, ecchymosis, bleeding, nausea, vomiting, fever will be quantified.
Measured: 6 months
Level of pain
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 Jul 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Austral de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro C Aravena, Universidad Austral de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773923
- Sponsor's protocol ID
- Osteoprint_2025
- Other IDs
- 23IRLR-249819
- Acronym
- OSTEOPRINT
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 38613813Rai 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.
PubMed 20688388Park 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.
PubMed 30282427Safiaghdam 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.
PubMed 36334300Rodrigues 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.
PubMed 22451140Ivanovski 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.
PubMed 37823472Obregon 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.
PubMed 26124216Ivanovski 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.
PubMed 39109582Park 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.
PubMed 36796059
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06773923
- Acronym / sponsor ID
- OSTEOPRINT / Osteoprint_2025
- Keywords
- Polycaprolactone, Scaffold, Bone regeneration, Printing, three dimensional, Dentistry, Clinical Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universidad Austral de ChileUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteoprint group | Experimental | Device: PCL ScaffoldPatients with of their jaw/jawbone in which the 3D scaffold printed with PCL will be inserted. |
| Control group | Active comparator | Device: PTFE + Bio-Oss®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). |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCL Scaffoldpatients with their jaw/maxilla in which the 3D scaffold with PCL will be inserted. | Device | Osteoprint group |
| 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 | Device | Control group |
Primary outcome
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.
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.
3 secondary outcomes
Oral Health Quality of life.
Time frame: 6 months
Postoperative complications
Time frame: 6 months
Level of pain
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Background: PubMed 38613813Dalfino 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.
- Background: PubMed 20688388Rai 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.
- Background: PubMed 30282427Park 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.
- Background: PubMed 36334300Safiaghdam 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.
- Background: PubMed 22451140Rodrigues 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.
- Background: PubMed 37823472Ivanovski 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.
- Background: PubMed 26124216Obregon 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.
- Background: PubMed 39109582Ivanovski 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.
- Background: PubMed 36796059Park 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.
- Individual participant dataSharing planned: No
Related trials for Bone Loss
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Not yet recruitingPhase 2
Melatonin in Posterior Mandible Extraction Socket
Bone Loss
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
Active, not recruiting
AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone Density
Osteopenia
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PCL Scaffold and PTFE + Bio-Oss® in people with Bone Loss and Jaw, Edentulous, run by Universidad Austral de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histology: area new bone tissue (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06773923, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.