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Study to Evaluate Implant Survival Rate of Astra Tech Fixture ST in the Posterior Maxilla With One-stage Surgery and Early Loading

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT00748241
First received: September 5, 2008
Last updated: January 12, 2012
Last verified: January 2012
History of Changes
Results First Received: August 23, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Jaw, Edentulous, Partially
Intervention: Device: Astra Tech Fixture ST

  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
Astra Tech Fixture ST Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.

Participant Flow:   Overall Study
    Astra Tech Fixture ST  
STARTED     19  
COMPLETED     11  
NOT COMPLETED     8  
Implant failure                 1  
Lost to Follow-up                 5  
Death                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Astra Tech Fixture ST Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.

Baseline Measures
    Astra Tech Fixture ST  
Number of Participants  
[units: participants]
 		  19  
Age  
[units: years]
Mean ± Standard Deviation 		  61.0  ± 11.3  
Gender  
[units: participants]
 		 
Female     2  
Male     17  
Region of Enrollment  
[units: participants]
 		 
United States     19  



  Outcome Measures
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1.  Primary:   Implant Survival Rate   [ Time Frame: At follow-up visit: 6 months after implants have been loaded ]
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2.  Primary:   Implant Survival Rate   [ Time Frame: At follow-up visit: 1 year after implants have been loaded ]
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3.  Primary:   Implant Survival Rate   [ Time Frame: At follow-up visit: 2 years after implants have been loaded ]
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4.  Primary:   Implant Survival Rate   [ Time Frame: At follow-up visit: 3 years after implants have been loaded ]
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5.  Secondary:   Implant Failure   [ Time Frame: 3 years after implant placement ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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