NCT06269497

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

November 30, 2023

Last Update Submit

February 12, 2024

Conditions

Alveolar Bone Resorption

Keywords

ScaffoldBone resorption

Outcome Measures

Primary Outcomes (1)

  • Adverse reactions

    Evaluate and register any adverse reactions following placement of the scaffold

    Through study completion, an average of 1 year

Secondary Outcomes (3)

  • Anatomy

    6 months after surgery

  • Inflammation

    Through study completion, an average of 1 year

  • Mineralization

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

Study Arms (1)

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.

Procedure: Scaffold placementRadiation: CBCT

Interventions

Scaffold placementPROCEDURE

The scaffold is placed in the alveola following extraction

Scaffold
CBCTRADIATION

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

Scaffold

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, University of Oslo

Oslo, Postboks 1142 Blindern, Norway

Location

Related Publications (11)

  • 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.

    PMID: 25394623BACKGROUND

  • 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.

    PMID: 20711636BACKGROUND

  • 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.

    PMID: 20089606BACKGROUND

  • 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.

    PMID: 22395069BACKGROUND

  • 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.

    PMID: 20057018BACKGROUND

  • 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.

    PMID: 23091493BACKGROUND

  • 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.

    PMID: 34823602BACKGROUND

  • 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.

    PMID: 33420723BACKGROUND

  • 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.

    PMID: 36222116BACKGROUND

  • 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.

    PMID: 28824306BACKGROUND

  • 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. 2025 Nov 30. doi: 10.1111/clr.70074. Online ahead of print.

    PMID: 41320732DERIVED

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Officials

  • Jan Eirik Ellingsen, DDS, PhD

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Observational study / clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 30, 2023

First Posted

February 21, 2024

Study Start

November 9, 2021

Primary Completion

June 20, 2022

Study Completion

August 10, 2023

Last Updated

February 21, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)