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Alveolar Bone ResorptionTIOSCAFFNCT06269497

TiO2-scaffolds for Alveolar Ridge Preservation

A study testing Scaffold placement and CBCT in people with Alveolar Bone Resorption, run by University of Oslo at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Alveolar Bone Resorption
What is being tested?
Scaffold placement and CBCT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteNorway
Study dates
9 Nov 2021to 10 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

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 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subject must be ≥ 20 years, and present with a molar or premolar planned for extraction

Who cannot join

  • Individuals with medical conditions that may affect soft tissue or bone metabolism
  • Previous local radiotherapy
  • Current use of chemotherapy
  • Systemic long-term corticosteroid treatment.
  • Diabetes
  • Smokers (> 10 cigarettes/day).
Show all 11Show fewer
  • Patients with active of untreated periodontal disease.
  • Present or past use of bisphosphonate treatment
  • Pregnant or nursing subjects
  • > class 2 according to the ASA (American Society of Anesthesiologists) physical status classification
  • Acute infection or no apical periodontitis visible on radiograph of tooth planned for extraction.

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Faculty of Dentistry, University of Oslo

    Oslo, Postboks 1142 Blindern

Other trials in Norway

About this study

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.

Read the detailed description

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.

Being tested
Scaffold placement, CBCT
Keywords
Scaffold, Bone resorption
Medical subject headings
Bone Resorption

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Scaffold placementProcedure or surgery

    The scaffold is placed in the alveola following extraction

  • CBCTRadiation

    A Cone Beam Computer Tomography (CBCT) is taken of the area of interest after surgery

Study groups in NCT06269497
Study groupRoleWhat they receive
ScaffoldExperimentalAfter tooth extraction will one scaffold be placed in the extraction alveola, covered by a membrane and then covered by the gingival tissue.
Receives: Procedure: Scaffold placement; Radiation: CBCT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse reactions

    Evaluate and register any adverse reactions following placement of the scaffold

    Measured: Through study completion, an average of 1 year

Secondary outcomes (3)

  1. 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.

    Measured: 6 months after surgery

  2. Inflammation

    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.

    Measured: Through study completion, an average of 1 year

  3. Mineralization

    Evaluate bone ingrowth and mineralization of the pores in the scaffold material by the use of micro-ct analysis, histology and immune histology

    Measured: Evaluation of the histology, specimens tasken 6 months after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2024
  2. Study start9 Nov 2021
  3. Primary completion20 Jun 2022
  4. Study completion10 Aug 2023

Resources

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 N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Observational study / clinical trial
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06269497
Sponsor's protocol ID
2018/2300
Acronym
TIOSCAFF
Status last verified
Feb 2024
First submitted
30 Nov 2023
Last updated
21 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25394623

  • 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.

    PubMed 20711636

  • 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.

    PubMed 20089606

  • 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.

    PubMed 22395069

  • 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.

    PubMed 20057018

  • 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.

    PubMed 23091493

  • 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.

    PubMed 34823602

  • 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.

    PubMed 33420723

  • 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.

    PubMed 36222116

  • 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.

    PubMed 28824306

  • Jamous R, Nysaether I, Haugen HJ, Lyngstadaas SP, Fredriksson MV, Ellingsen JE, Khassawna TE. Multi-Scale Assessment of Scaffold-Guided Regeneration in Human Extraction Sockets Using an Ultra-Porous TiO(2) Biomaterial. Acta Biomater. 2026 Aug 20:S1742-7061(26)00573-8. doi: 10.1016/j.actbio.2026.08.041. Online ahead of print.

    PubMed 42624348

  • 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.

    PubMed 41320732

Questions about this trial

What is this clinical trial studying?

A study testing Scaffold placement and CBCT in people with Alveolar Bone Resorption, run by University of Oslo at 1 site in Norway.

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 1 inclusion and 11 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: finished, as of the sponsor's last update on 21 Feb 2024. 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 Norway. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Adverse reactions (time frame: Through study completion, an average of 1 year). 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 NCT06269497, which also lists 12 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 21 Feb 2024.

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