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Bioactive Glass Composite Implants in Cranial Bone Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01202838
Recruitment Status : Unknown
Verified September 2010 by Turku University Hospital.
Recruitment status was:  Recruiting
First Posted : September 16, 2010
Last Update Posted : September 16, 2010
University of Turku
Information provided by:
Turku University Hospital

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.

Condition or disease Intervention/treatment
Bone Substitutes Device: Composite Implant

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.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Bioactive Glass Composite Implants in Cranial Bone Reconstruction
Study Start Date : June 2008
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Composite Implant
Subject receiving composite implant
Device: Composite Implant
Subjects receiving composite implants

Primary Outcome Measures :
  1. Clinical success [ Time Frame: 3 years ]
    Clinical success is evaluated using clinical and radiographic examination, and blood count.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01202838

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Contact: Matti J Peltola, MD, PhD, DDS +35823130000
Contact: Kalle MJ Aitasalo, MD, PhD, DDS +35823130000

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Turku University Hospital Recruiting
Turku, Finland, 20521
Principal Investigator: Matti J Peltola, MD, PhD, DDS         
Sponsors and Collaborators
Turku University Hospital
University of Turku
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Principal Investigator: Matti J Peltola, MD, PhD, DDS Turku University Hospital
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Responsible Party: Matti Peltola, adjunct professor, Turku University Hospital Identifier: NCT01202838    
Other Study ID Numbers: MP125/2008
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: September 16, 2010
Last Verified: September 2010
Keywords provided by Turku University Hospital:
Cranial bone reconstruction, composite