Bioactive Glass Composite Implants in Cranial Bone Reconstruction

NCT01202838 | Unknown

• 1 other identifier: MP125/2008
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bone Substitutes

Keywords

Cranial bone reconstruction, composite

Outcome Measures

Primary Outcomes (1)

• Clinical success

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

  3 years

Study Arms (1)

Composite Implant

Subject receiving composite implant

Device: Composite Implant

Interventions

Composite Implant DEVICE

Subjects receiving composite implants

Composite Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients of Turku university hospital needing cranial bone defect reconstruction

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead
• University of Turku: collaborator

Study Sites (1)

Turku University Hospital

Turku, 20521, Finland

RECRUITING

Related Publications (5)

• 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.

  PMID: 18634960 BACKGROUND

• 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.

  PMID: 16823870 BACKGROUND

• 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.

  PMID: 17618510 BACKGROUND

• 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.

  PMID: 17619981 BACKGROUND

• 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.

  PMID: 17569007 BACKGROUND

Study Officials

• Matti J Peltola, MD, PhD, DDS

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matti J Peltola, MD, PhD, DDS

CONTACT

+35823130000; matti.peltola@tyks.fi

Kalle MJ Aitasalo, MD, PhD, DDS

CONTACT

+35823130000; kalle.aitasalo@tyks.fi

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: September 16, 2010
• Study Start: June 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 16, 2010

Record last verified: 2010-09

Locations

FI (1)