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Straumann Bone Ceramic Versus BioOss in Sinus Elevation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Straumann AG
ClinicalTrials.gov Identifier:
NCT00900822
First received: May 11, 2009
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
Results First Received: June 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Jaw, Edentulous, Partially
Alveolar Bone Loss
Interventions: Device: Straumann Bone Ceramic
Device: BioOss

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment started Oct 2005 and was completed June 2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Split-mouth design (test and control in the same patient).

Reporting Groups
  Description
Straumann BoneCeramic Synthetic bone graft material

Participant Flow for 2 periods

 Period 1:   9 Months Histological Evaluation
    Straumann BoneCeramic  
STARTED     11  
COMPLETED     11  
NOT COMPLETED     0  

Period 2:   12 Months Clinical Evaluation
    Straumann BoneCeramic  
STARTED     11  
COMPLETED     11  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Straumann Bone Ceramic Synthetic bone graft material

Baseline Measures
    Straumann Bone Ceramic  
Number of Participants  
[units: participants]
 		  11  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     7  
Age  
[units: years]
Mean ± Standard Deviation 		  65.27  ± 9.06  
Gender  
[units: participants]
 		 
Female     7  
Male     4  
Region of Enrollment  
[units: participants]
 		 
Sweden     11  



  Outcome Measures
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1.  Primary:   Histologically Measured Bone to Implant Contact (BIC)   [ Time Frame: 9 months after implant placement ]
  Show Outcome Measure 1

2.  Secondary:   Implant Survival Rate   [ Time Frame: 12 months after loading the implant ]
  Show Outcome Measure 2

3.  Secondary:   Implant Success Rate   [ Time Frame: 12 months after loading the implant ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Clinial Trial Manager
Organization: Institut Straumann AG
phone: +41 61 965 11 11
e-mail: info@straumann.com


Publications of Results:


Responsible Party: Institut Straumann AG
ClinicalTrials.gov Identifier: NCT00900822     History of Changes
Other Study ID Numbers: CR 02/05
Study First Received: May 11, 2009
Results First Received: June 6, 2012
Last Updated: July 31, 2012
Health Authority: Sweden: Medical Products Agency