Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to evaluate the safety of placing TiO2 scaffolds in alveolar ridge and to evaluate if the scaffold material contributes to maintain the anatomy and the volume of the alveolar process after tooth extraction.
The primary objective of the clinical trial is to evaluate the safety of placing TiO2 scaffolds in alveolar ridge.
The secondary objectives are; (1) to assess anatomical changes as measured by intraoral digital scanning at the time of extraction, after 6 months. (2) to evaluate soft tissue inflammation at 1, 2, 4, 12 and 24 weeks post-surgery, (3) to assess the preservation of the alveolar ridge following placement of TiO2 scaffold in the alveolae after tooth extraction, (4) to assess bone mineralization and quantitative healing in bone biopsies obtained at implant installation in the preserved site 6 months following treatment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scaffold | Experimental | After tooth extraction will one scaffold be placed in the extraction alveola, covered by a membrane and then covered by the gingival tissue. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scaffold placement | Procedure | The scaffold is placed in the alveola following extraction |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse reactions | Evaluate and register any adverse reactions following placement of the scaffold | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Anatomy | Evaluate if the anatomy of the alveolar process is maintained or changed, analysis with use of cone-beam-computer-tomography showing the bone at the site immediately after surgery and 6 months after surgery. Any difference in bone volume will be recorded. | 6 months after surgery |
| Inflammation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jan Eirik Ellingsen, DDS, PhD | University of Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, University of Oslo | Oslo | Postboks 1142 Blindern | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25394623 | Background | Muller B, Reseland JE, Haugen HJ, Tiainen H. Cell growth on pore-graded biomimetic TiO2 bone scaffolds. J Biomater Appl. 2015 Apr;29(9):1284-95. doi: 10.1177/0885328214559859. Epub 2014 Nov 13. | |
| 20711636 | Background | Tiainen H, Lyngstadaas SP, Ellingsen JE, Haugen HJ. Ultra-porous titanium oxide scaffold with high compressive strength. J Mater Sci Mater Med. 2010 Oct;21(10):2783-92. doi: 10.1007/s10856-010-4142-1. Epub 2010 Aug 14. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Observational study / clinical trial
Not provided
Not provided
Not provided
Not provided
| CBCT |
| Radiation |
A Cone Beam Computer Tomography (CBCT) is taken of the area of interest after surgery |
|
Evaluate if any inflammatory response appeared in the surrounding tissues following placement of the scaffold according to the modified Landry index (Pippi 2017), The inflammation parameters are recorded with "yes" or "no" regarding presence. |
| Through study completion, an average of 1 year |
| Mineralization | Evaluate bone ingrowth and mineralization of the pores in the scaffold material by the use of micro-ct analysis, histology and immune histology | Evaluation of the histology, specimens tasken 6 months after surgery. |
| 20089606 | Background | Sabetrasekh R, Tiainen H, Lyngstadaas SP, Reseland J, Haugen H. A novel ultra-porous titanium dioxide ceramic with excellent biocompatibility. J Biomater Appl. 2011 Feb;25(6):559-80. doi: 10.1177/0885328209354925. Epub 2010 Jan 20. |
| 22395069 | Background | Tiainen H, Wohlfahrt JC, Verket A, Lyngstadaas SP, Haugen HJ. Bone formation in TiO2 bone scaffolds in extraction sockets of minipigs. Acta Biomater. 2012 Jul;8(6):2384-91. doi: 10.1016/j.actbio.2012.02.020. Epub 2012 Mar 3. |
| 20057018 | Background | Sabetrasekh R, Tiainen H, Reseland JE, Will J, Ellingsen JE, Lyngstadaas SP, Haugen HJ. Impact of trace elements on biocompatibility of titanium scaffolds. Biomed Mater. 2010 Feb;5(1):15003. doi: 10.1088/1748-6041/5/1/015003. Epub 2010 Jan 7. |
| 23091493 | Background | Tiainen H, Verket A, Haugen HJ, Lyngstadaas SP, Wohlfahrt JC. Dimensional Ridge Preservation with a Novel Highly Porous TiO(2) Scaffold: An Experimental Study in Minipigs. Int J Biomater. 2012;2012:851264. doi: 10.1155/2012/851264. Epub 2012 Oct 3. |
| 34823602 | Background | Le Thieu MK, Homayouni A, Haeren LR, Tiainen H, Verket A, Ellingsen JE, Ronold HJ, Wohlfahrt JC, Cantalapiedra AG, Munoz FMG, Mendana MP, Lyngstadaas SP, Haugen HJ. Impact of simultaneous placement of implant and block bone graft substitute: an in vivo peri-implant defect model. Biomater Res. 2021 Nov 25;25(1):43. doi: 10.1186/s40824-021-00245-3. |
| 33420723 | Background | Thieu MKL, Haugen HJ, Sanz-Esporrin J, Sanz M, Lyngstadaas SP, Verket A. Guided bone regeneration of chronic non-contained bone defects using a volume stable porous block TiO2 scaffold: An experimental in vivo study. Clin Oral Implants Res. 2021 Mar;32(3):369-381. doi: 10.1111/clr.13708. Epub 2021 Jan 28. |
| 36222116 | Background | Thieu MKL, Stoetzel S, Rahmati M, El Khassawna T, Verket A, Sanz-Esporrin J, Sanz M, Ellingsen JE, Haugen HJ. Immunohistochemical comparison of lateral bone augmentation using a synthetic TiO2 block or a xenogeneic graft in chronic alveolar defects. Clin Implant Dent Relat Res. 2023 Feb;25(1):57-67. doi: 10.1111/cid.13143. Epub 2022 Oct 12. |
| 28824306 | Background | Pippi R. Post-Surgical Clinical Monitoring of Soft Tissue Wound Healing in Periodontal and Implant Surgery. Int J Med Sci. 2017 Jul 18;14(8):721-728. doi: 10.7150/ijms.19727. eCollection 2017. |
| 41320732 | Derived | Nysaether I, Haugen HJ, El Khassawna T, Jamous R, Afnan S, Santacroce M, Arvidsson LZ, Hildebrand T, Lyngstadaas SP, Ellingsen JE. Clinical Performance of Ultra-Porous TiO2 Scaffold as Bone Graft Substitute in Human Alveolar Ridge Preservation-A Feasibility Study. Clin Oral Implants Res. 2026 Mar;37(3):327-344. doi: 10.1111/clr.70074. Epub 2025 Nov 30. |