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Status unknownNCT01202838Updated Sep 16, 2010

Bioactive Glass Composite Implants in Cranial Bone Reconstruction

An observational study in Bone Substitutes, sponsored by Turku University Hospital. Status unknown at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-09-16.

Sponsored by Turku University Hospital · Observational

The sponsor has not verified this record recently (last verified Sep 2010), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to study composites of bioactive glass and methylmetacrylate with glass fibre reinforcement in cranial bone defect reconstruction.

Read the detailed description

Traditional skull and facial bone reconstructions with hard tissues have a long history with good clinical outcomes. However, they have certain disadvantages. The benefits of synthetic materials are the avoidance of donor-site morbidity and scars, but also shorter hospitalization time, lower expenses and known composition. Custom-made skull bone implant can produced based on patients clinical need utilizing rapid prototyping technologies. This will result in very high accuracy of the form of the skull defect.

Polymethylmetacrylate (PMMA) is one of the most widely used alloplastic material in surgery. Bioactive glass S53P4 (BAG) particles have been used in various clinical indications. BAG was added to composite implant of PMMA with glass fibre reinforcement to enhance bone ingrowth to implant, and to utilize BAG's antimicrobial effects. Ten patients cranial defects are treated with composite implants.

02

Conditions studied

  • Bone Substitutes

Keywords

  • Cranial bone reconstruction, composite
03

In context

Lead sponsor

Turku University Hospital is the lead sponsor of 280 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients of Turku university hospital needing cranial bone defect reconstruction

Inclusion criteria

  • patients with cranial bone defect larger than 4x4 cm after trauma or tumor surgery
  • patient signs written study consent

Exclusion criteria

Exclusion Criteria:

  • patient is unlikely to adhere to study procedures
  • patient has a disease or condition that in the opinion of investigator is contraindicating participation
  • patient is participating another medical device or drug trial
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
10 participants (estimated)

Groups and cohorts

  • Composite Implant

    Subject receiving composite implant

    Device: Composite Implant

Interventions

  • DeviceComposite Implant

    Subjects receiving composite implants

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What researchers measure

Primary outcomes

  1. Clinical success

    Clinical success is evaluated using clinical and radiographic examination, and blood count.

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • Turku University Hospital
    Turku, 20521, Finland
    • Matti J Peltola, MD, PhD, DDS · Principal investigator
    Recruiting
08

References and documents

Publications

  • Peltola MJ, Aitasalo KM, Aho AJ, Tirri T, Suonpaa JT. Long-term microscopic and tissue analytical findings for 2 frontal sinus obliteration materials. J Oral Maxillofac Surg. 2008 Aug;66(8):1699-707. doi: 10.1016/j.joms.2007.11.020. No abstract available. PubMed 18634960 ↗
  • Peltola M, Aitasalo K, Suonpaa J, Varpula M, Yli-Urpo A. Bioactive glass S53P4 in frontal sinus obliteration: a long-term clinical experience. Head Neck. 2006 Sep;28(9):834-41. doi: 10.1002/hed.20436. PubMed 16823870 ↗
  • Tuusa SM, Peltola MJ, Tirri T, Puska MA, Roytta M, Aho H, Sandholm J, Lassila LV, Vallittu PK. Reconstruction of critical size calvarial bone defects in rabbits with glass-fiber-reinforced composite with bioactive glass granule coating. J Biomed Mater Res B Appl Biomater. 2008 Feb;84(2):510-9. doi: 10.1002/jbm.b.30898. PubMed 17618510 ↗
  • Lepparanta O, Vaahtio M, Peltola T, Zhang D, Hupa L, Hupa M, Ylanen H, Salonen JI, Viljanen MK, Eerola E. Antibacterial effect of bioactive glasses on clinically important anaerobic bacteria in vitro. J Mater Sci Mater Med. 2008 Feb;19(2):547-51. doi: 10.1007/s10856-007-3018-5. Epub 2007 Jul 10. PubMed 17619981 ↗
  • Munukka E, Lepparanta O, Korkeamaki M, Vaahtio M, Peltola T, Zhang D, Hupa L, Ylanen H, Salonen JI, Viljanen MK, Eerola E. Bactericidal effects of bioactive glasses on clinically important aerobic bacteria. J Mater Sci Mater Med. 2008 Jan;19(1):27-32. doi: 10.1007/s10856-007-3143-1. Epub 2007 Jun 14. PubMed 17569007 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01202838
Lead sponsor
Turku University Hospital
Collaborators
University of Turku
First posted
Sep 16, 2010
Start date
Jun 2008
Primary completion
Dec 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Sep 16, 2010

Study contacts

Matti J Peltola, MD, PhD, DDS
Contact
matti.peltola@tyks.fi
+35823130000
Kalle MJ Aitasalo, MD, PhD, DDS
Contact
kalle.aitasalo@tyks.fi
+35823130000
Matti J Peltola, MD, PhD, DDS
principal investigator · Turku University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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