Bone Tissue Engineering Using Autologous Bone Repair Cell (BRC) Therapy for Sinus Floor Bone Augmentation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William Giannobile, University of Michigan
ClinicalTrials.gov Identifier:
NCT00980278
First received: September 18, 2009
Last updated: November 18, 2015
Last verified: November 2015
Results First Received: July 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tooth Loss
Interventions: Procedure: Sinus lift augmentation and dental implant
Biological: Aastrom BRCs

  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
Sinus Lift Plus Dental Implant

Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.

Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.

Biological/Vaccine: N/A; only sinus augmentation and dental implant

Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.

Sinus Lift Plus BRCs and Dental Implant

transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.

Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.

Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant

Aastrom BRCs: sinus augmentation, BRC application, dental implant


Participant Flow:   Overall Study
    Sinus Lift Plus Dental Implant     Sinus Lift Plus BRCs and Dental Implant  
STARTED     13     13  
COMPLETED     11     13  
NOT COMPLETED     2     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
Sinus Lift Plus Dental Implant

Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.

Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.

Biological/Vaccine: N/A; only sinus augmentation and dental implant

Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.

Sinus Lift Plus BRCs and Dental Implant

transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.

Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.

Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant

Aastrom BRCs: sinus augmentation, BRC application, dental implant

Total Total of all reporting groups

Baseline Measures
    Sinus Lift Plus Dental Implant     Sinus Lift Plus BRCs and Dental Implant     Total  
Number of Participants  
[units: participants]
  13     13     26  
Age, Customized  
[units: participants]
     
>20 and <70     13     13     26  
Gender  
[units: participants]
     
Female     10     10     20  
Male     3     3     6  
Region of Enrollment  
[units: participants]
     
United States     13     13     26  



  Outcome Measures
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1.  Primary:   Bone Mineral Density of Bone Core   [ Time Frame: 4 months ]

2.  Primary:   Bone Volume Fraction of Bone Core   [ Time Frame: 4 months ]

3.  Secondary:   Change in Linear Radiographic Bone Height   [ Time Frame: Screening and 1 week post-op from baseline ]

4.  Secondary:   Change in Sinus Bone Volume   [ Time Frame: Pre-baseline and within 2 weeks of 4 Month visit ]

5.  Secondary:   Final Bone Volume: Initial Graft Volume Ratio   [ Time Frame: 4 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 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.


Results Point of Contact:  
Name/Title: Dr. William Giannobile, Chair Department of Periodontics and Oral Medicine
Organization: University of Michigan School of Dentistry
phone: 734-763-2105
e-mail: wgiannob@umich.edu


Publications of Results:
Other Publications:


Responsible Party: William Giannobile, University of Michigan
ClinicalTrials.gov Identifier: NCT00980278     History of Changes
Other Study ID Numbers: HUM00014299
Study First Received: September 18, 2009
Results First Received: July 10, 2015
Last Updated: November 18, 2015
Health Authority: United States: Food and Drug Administration