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

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ClinicalTrials.gov Identifier: NCT00980278
Recruitment Status : Completed
First Posted : September 21, 2009
Results First Posted : December 23, 2015
Last Update Posted : December 23, 2015
Sponsor:
Information provided by (Responsible Party):
William Giannobile, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tooth Loss
Interventions Procedure: Sinus lift augmentation and dental implant
Biological: Aastrom BRCs
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sinus Lift Plus Dental Implant Sinus Lift Plus BRCs and Dental Implant
Hide Arm/Group Description

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.

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

Period Title: Overall Study
Started 13 13
Completed 11 13
Not Completed 2 0
Arm/Group Title Sinus Lift Plus Dental Implant Sinus Lift Plus BRCs and Dental Implant Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 13 13 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
>20 and <70 Number Analyzed 13 participants 13 participants 26 participants
13 13 26
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Female
10
  76.9%
10
  76.9%
20
  76.9%
Male
3
  23.1%
3
  23.1%
6
  23.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 13 participants 26 participants
13 13 26
1.Primary Outcome
Title Bone Mineral Density of Bone Core
Hide Description Bone mineral density of bone core was measured by histological and µCT analyses
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sinus Lift Plus Dental Implant Sinus Lift Plus BRCs and Dental Implant
Hide Arm/Group Description:

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.

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

Overall Number of Participants Analyzed 11 13
Mean (Standard Deviation)
Unit of Measure: mg/mm^3
.79  (.05) .78  (.02)
2.Primary Outcome
Title Bone Volume Fraction of Bone Core
Hide Description Bone volume fraction of bone core histological and µCT analyses
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sinus Lift Plus Dental Implant Sinus Lift Plus BRCs and Dental Implant
Hide Arm/Group Description:

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.

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

Overall Number of Participants Analyzed 11 13
Mean (Standard Deviation)
Unit of Measure: ratio
.43  (8.1) .49  (7.2)
3.Secondary Outcome
Title Change in Linear Radiographic Bone Height
Hide Description Change in linear radiographic bone heights were measured before and after bone graft reconstruction
Time Frame Screening and 1 week post-op from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sinus Lift Plus Dental Implant Sinus Lift Plus BRCs and Dental Implant
Hide Arm/Group Description:

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.

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

Overall Number of Participants Analyzed 11 13
Mean (Standard Deviation)
Unit of Measure: mm
12.8  (2.8) 12.2  (3.3)
4.Secondary Outcome
Title Change in Sinus Bone Volume
Hide Description CBCT was used to evaluated 3-D changes in the bone volume within the treated areas of the sinus cavity
Time Frame Pre-baseline and within 2 weeks of 4 Month visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sinus Lift Plus Dental Implant Sinus Lift Plus BRCs and Dental Implant
Hide Arm/Group Description:

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.

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

Overall Number of Participants Analyzed 11 13
Mean (Standard Deviation)
Unit of Measure: cm3
2.1  (.9) 1.8  (1.0)
5.Secondary Outcome
Title Final Bone Volume: Initial Graft Volume Ratio
Hide Description Bone volume fraction of bone core histological and µCT analyses
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sinus Lift Plus Dental Implant Sinus Lift Plus BRCs and Dental Implant
Hide Arm/Group Description:

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.

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

Overall Number of Participants Analyzed 11 13
Mean (Standard Deviation)
Unit of Measure: ratio
.64  (.2) .51  (.3)
Time Frame 4 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sinus Lift Plus Dental Implant Sinus Lift Plus BRCs and Dental Implant
Hide Arm/Group Description

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.

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

All-Cause Mortality
Sinus Lift Plus Dental Implant Sinus Lift Plus BRCs and Dental Implant
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sinus Lift Plus Dental Implant Sinus Lift Plus BRCs and Dental Implant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/13 (7.69%)      1/13 (7.69%)    
Infections and infestations     
Sinus   0/13 (0.00%)  0 1/13 (7.69%)  13
Surgical and medical procedures     
Surgery   1/13 (7.69%)  13 0/13 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sinus Lift Plus Dental Implant Sinus Lift Plus BRCs and Dental Implant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/13 (69.23%)      9/13 (69.23%)    
Gastrointestinal disorders     
Vomitting *  1/13 (7.69%)  1 2/13 (15.38%)  2
General disorders     
Lesion *  1/13 (7.69%)  1 0/13 (0.00%)  0
Bleeding *  1/13 (7.69%)  1 0/13 (0.00%)  0
Broken Tooth *  2/13 (15.38%)  2 0/13 (0.00%)  0
Suture Loss *  0/13 (0.00%)  0 1/13 (7.69%)  1
Pain and Swelling *  0/13 (0.00%)  0 2/13 (15.38%)  2
Flap Mobility *  1/13 (7.69%)  1 0/13 (0.00%)  0
Sore Throat *  0/13 (0.00%)  0 1/13 (7.69%)  1
Non-restoreable Tooth *  0/13 (0.00%)  0 1/13 (7.69%)  1
Headaches *  0/13 (0.00%)  0 1/13 (7.69%)  1
Oral Ulcer *  1/13 (7.69%)  1 0/13 (0.00%)  0
Tingling *  0/13 (0.00%)  0 1/13 (7.69%)  1
Lack of Bone *  1/13 (7.69%)  1 1/13 (7.69%)  1
Rash *  1/13 (7.69%)  1 0/13 (0.00%)  0
Pain *  2/13 (15.38%)  2 1/13 (7.69%)  1
Discomfort *  0/13 (0.00%)  0 1/13 (7.69%)  1
Prosthesis Came Off *  6/13 (46.15%)  6 2/13 (15.38%)  2
Sensitivity *  0/13 (0.00%)  0 1/13 (7.69%)  1
Bleeding *  0/13 (0.00%)  0 1/13 (7.69%)  1
Tenderness *  0/13 (0.00%)  0 1/13 (7.69%)  1
Ovarian Ulcer Rupture *  1/13 (7.69%)  1 0/13 (0.00%)  0
Infections and infestations     
Infection *  1/13 (7.69%)  1 0/13 (0.00%)  0
Injury, poisoning and procedural complications     
Soft Tissue Opening *  2/13 (15.38%)  2 0/13 (0.00%)  0
Injury *  0/13 (0.00%)  0 3/13 (23.08%)  3
Swelling *  0/13 (0.00%)  0 1/13 (7.69%)  1
Exostosis *  0/13 (0.00%)  0 1/13 (7.69%)  1
Perforations *  0/13 (0.00%)  0 1/13 (7.69%)  1
Skin and subcutaneous tissue disorders     
Shingles *  1/13 (7.69%)  1 0/13 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
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
Other Publications:
Responsible Party: William Giannobile, University of Michigan
ClinicalTrials.gov Identifier: NCT00980278     History of Changes
Other Study ID Numbers: HUM00014299
First Submitted: September 18, 2009
First Posted: September 21, 2009
Results First Submitted: July 10, 2015
Results First Posted: December 23, 2015
Last Update Posted: December 23, 2015