Bioactive Glass Composite Implants in Cranial Bone Reconstruction
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Bone Substitutes||Device: Composite Implant||Early Phase 1|
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.
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|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|
Subject receiving composite implant
Device: Composite Implant
Subjects receiving composite implants
- Clinical success [ Time Frame: 3 years ]Clinical success is evaluated using clinical and radiographic examination, and blood count.
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 ClinicalTrials.gov identifier (NCT number): NCT01202838
|Contact: Matti J Peltola, MD, PhD, DDSfirstname.lastname@example.org|
|Contact: Kalle MJ Aitasalo, MD, PhD, DDSemail@example.com|
|Turku University Hospital||Recruiting|
|Turku, Finland, 20521|
|Principal Investigator: Matti J Peltola, MD, PhD, DDS|
|Principal Investigator:||Matti J Peltola, MD, PhD, DDS||Turku University Hospital|