TiO2-scaffolds for Alveolar Ridge Preservation

Alveolar Bone Resorption Clinical Trial

— TIOSCAFF  

Official title:

TiO2-scaffolds for Alveolar Ridge Preservation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06269497
• Other study ID #: 2018/2300
• Status: Completed
• Phase: N/A
• Start date: November 9, 2021
• Est. completion date: August 10, 2023

Study information

• Verified date: February 2024
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 10, 2023
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Alveolar Bone Resorption
• Bone Resorption

Intervention

Procedure:
• Scaffold placement
The scaffold is placed in the alveola following extraction

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

Locations

Country	Name	City	State
Norway	Faculty of Dentistry, University of Oslo	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse reactions	Evaluate and register any adverse reactions following placement of the scaffold	Through study completion, an average of 1 year
Secondary	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
Secondary	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.	Through study completion, an average of 1 year
Secondary	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.