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Comparison of Synthetic Bone Substitute and a Bovine-derived Xenograft in Horizontal Bone Augmentation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Straumann AG
ClinicalTrials.gov Identifier:
NCT00901017
First received: May 11, 2009
Last updated: October 4, 2012
Last verified: October 2012
History of Changes
Results First Received: August 30, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Jaw, Edentulous
Jaw, Edentulous, Partially
Interventions: Device: Straumann BoneCeramic
Device: Bio-Oss

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Straumann BoneCeramic and Geistlich Bio-Oss Each patient received both treatments in a split-mouth design.

Participant Flow:   Overall Study
    Straumann BoneCeramic and Geistlich Bio-Oss  
STARTED     14  
COMPLETED     14  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Straumann BoneCeramic and Geistlich Bio-Oss Each patient received both treatments in a split-mouth design.

Baseline Measures
    Straumann BoneCeramic and Geistlich Bio-Oss  
Number of Participants  
[units: participants]
 		  14  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     12  
>=65 years     2  
Age  
[units: years]
Mean ± Standard Deviation 		  55.1  ± 9.9  
Gender  
[units: participants]
 		 
Female     12  
Male     2  
Region of Enrollment  
[units: participants]
 		 
Belgium     14  



  Outcome Measures
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1.  Primary:   Change of Vertical Height of Buccal Defects   [ Time Frame: Baseline to 26 weeks ]
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2.  Secondary:   Implant Success Rate   [ Time Frame: 6 months ]
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3.  Secondary:   Implant Survival Rate   [ Time Frame: 6 Months ]
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4.  Secondary:   Implant Success Rate   [ Time Frame: 12 months ]
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5.  Secondary:   Implant Survival Rate   [ Time Frame: 12 months ]
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  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
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Results Point of Contact:  
Name/Title: Marc Quirynen, Professor
Organization: Institut Straumann AG
phone: +4161965 ext 1235
e-mail: michael.hotze@straumann.com


No publications provided


Responsible Party: Institut Straumann AG
ClinicalTrials.gov Identifier: NCT00901017     History of Changes
Other Study ID Numbers: CR 04/05
Study First Received: May 11, 2009
Results First Received: August 30, 2012
Last Updated: October 4, 2012
Health Authority: Belgium: Institutional Review Board