Study to Evaluate an Implant With a Sloped Top in Patients With a Sloped Jaw Bone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT00807456
First received: December 11, 2008
Last updated: April 26, 2016
Last verified: April 2016
Results First Received: March 16, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Edentulism
Intervention: Device: ASTRA TECH Implant System, OsseoSpeed™

  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
No text entered.

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 Implant System, OsseoSpeed™ Profile ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.

Participant Flow:   Overall Study
    ASTRA TECH Implant System, OsseoSpeed™ Profile  
STARTED     65  
COMPLETED     65  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
ASTRA TECH Implant System, OsseoSpeed™ Profile ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.

Baseline Measures
    ASTRA TECH Implant System, OsseoSpeed™ Profile  
Number of Participants  
[units: participants]
  65  
Age  
[units: years]
Mean (Standard Deviation)
  49.05  (13.974)  
Gender  
[units: participants]
 
Female     33  
Male     32  



  Outcome Measures

1.  Primary:   Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to 16 Weeks After Implant Placement   [ Time Frame: At baseline and 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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 more than 60 days but less than or equal to 180 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.


Results Point of Contact:  
Name/Title: Manager Global Clinical Affairs
Organization: DENTSPLY Implants
phone: +46313763500
e-mail: ClinicalResearchMolndal@dentsplysirona.com


Publications of Results:

Responsible Party: Dentsply Implants
ClinicalTrials.gov Identifier: NCT00807456     History of Changes
Other Study ID Numbers: YA-PRO-0001
Study First Received: December 11, 2008
Results First Received: March 16, 2016
Last Updated: April 26, 2016
Health Authority: Germany: Ethics Commission
Italy: Ethics Committee
Sweden: Regional Ethical Review Board
United States: Institutional Review Board