A Study of Dental Implants Coated With Bone Morphogenetic Protein

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nobel Biocare
ClinicalTrials.gov Identifier:
NCT00422279
First received: January 11, 2007
Last updated: May 11, 2015
Last verified: May 2015
Results First Received: January 17, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator)
Condition: Alveolar Ridge Abnormality
Intervention: Device: Implant

  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
Four patients have been recruited to participate in this study after they met the inclusion criteria, all patients have been recruited at the Medical college of Georgia, Augusta, GA, USA

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
all the four study patients met the inclusion criteria no run in's have been encountered, all the patients completed this study at the scheduled follow up visits

Reporting Groups
  Description
Supraalveolar Position bone inductive implants placed in supraalveolar position
Extraction Sites bone inductive implants placed in tooth extraction sockets

Participant Flow:   Overall Study
    Supraalveolar Position     Extraction Sites  
STARTED     2     2  
24 Month After Loading Period     2     2  
COMPLETED     2     2  
NOT COMPLETED     0     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.
No text entered.

Reporting Groups
  Description
Supralveolar Position bone inductive implants placed in supraalveolar position
Extraction Sites bone inductive implants placed in tooth extraction sites
Total Total of all reporting groups

Baseline Measures
    Supralveolar Position     Extraction Sites     Total  
Number of Participants  
[units: participants]
  2     2     4  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     2     1     3  
>=65 years     0     1     1  
Gender  
[units: participants]
     
Female     2     2     4  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     2     2     4  



  Outcome Measures
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1.  Primary:   Primary Endpoint Was to Assess Implant Stability of the Implants( 4 Patients in Two Groups With a Total of 8 Implants) at Baseline and After 3 Months of Submerged Healing and After 6 Months of Prosthetic Loading   [ Time Frame: Implant insertion, 3 months, 6 months ]

2.  Secondary:   Number of Participants Showing Bone Growth With rhBMP-2 (15 and 30 µg Per Implant)   [ Time Frame: 3 months ]


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Dr. Ann Jannu, Clinical Research Manager
Organization: Nobel Biocare
phone: 201-529-7103
e-mail: ann.jannu@nobelbiocare.com


Publications of Results:

Responsible Party: Nobel Biocare
ClinicalTrials.gov Identifier: NCT00422279     History of Changes
Other Study ID Numbers: CR06:3393
Study First Received: January 11, 2007
Results First Received: January 17, 2012
Last Updated: May 11, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration