Trial Outcomes & Findings for Bone Tissue Engineering Using Autologous Bone Repair Cell (BRC) Therapy for Sinus Floor Bone Augmentation (NCT NCT00980278)
NCT ID: NCT00980278
Last Updated: 2015-12-23
Results Overview
Bone mineral density of bone core was measured by histological and µCT analyses
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
26 participants
Primary outcome timeframe
4 months
Results posted on
2015-12-23
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
11
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bone Tissue Engineering Using Autologous Bone Repair Cell (BRC) Therapy for Sinus Floor Bone Augmentation
Baseline characteristics by cohort
| Measure |
Sinus Lift Plus Dental Implant
n=13 Participants
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
n=13 Participants
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
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>20 and <70
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsBone mineral density of bone core was measured by histological and µCT analyses
Outcome measures
| Measure |
Sinus Lift Plus Dental Implant
n=11 Participants
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
n=13 Participants
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
|
|---|---|---|
|
Bone Mineral Density of Bone Core
|
.79 mg/mm^3
Standard Deviation .05
|
.78 mg/mm^3
Standard Deviation .02
|
PRIMARY outcome
Timeframe: 4 monthsBone volume fraction of bone core histological and µCT analyses
Outcome measures
| Measure |
Sinus Lift Plus Dental Implant
n=11 Participants
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
n=13 Participants
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
|
|---|---|---|
|
Bone Volume Fraction of Bone Core
|
.43 ratio
Standard Deviation 8.1
|
.49 ratio
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: Screening and 1 week post-op from baselineChange in linear radiographic bone heights were measured before and after bone graft reconstruction
Outcome measures
| Measure |
Sinus Lift Plus Dental Implant
n=11 Participants
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
n=13 Participants
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
|
|---|---|---|
|
Change in Linear Radiographic Bone Height
|
12.8 mm
Standard Deviation 2.8
|
12.2 mm
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Pre-baseline and within 2 weeks of 4 Month visitCBCT was used to evaluated 3-D changes in the bone volume within the treated areas of the sinus cavity
Outcome measures
| Measure |
Sinus Lift Plus Dental Implant
n=11 Participants
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
n=13 Participants
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
|
|---|---|---|
|
Change in Sinus Bone Volume
|
2.1 cm3
Standard Deviation .9
|
1.8 cm3
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 4 monthsBone volume fraction of bone core histological and µCT analyses
Outcome measures
| Measure |
Sinus Lift Plus Dental Implant
n=11 Participants
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
n=13 Participants
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
|
|---|---|---|
|
Final Bone Volume: Initial Graft Volume Ratio
|
.64 ratio
Standard Deviation .2
|
.51 ratio
Standard Deviation .3
|
Adverse Events
Sinus Lift Plus Dental Implant
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Sinus Lift Plus BRCs and Dental Implant
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sinus Lift Plus Dental Implant
n=13 participants at risk
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
n=13 participants at risk
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
|
|---|---|---|
|
Infections and infestations
Sinus
|
0.00%
0/13 • 4 years
|
7.7%
1/13 • Number of events 13 • 4 years
|
|
Surgical and medical procedures
Surgery
|
7.7%
1/13 • Number of events 13 • 4 years
|
0.00%
0/13 • 4 years
|
Other adverse events
| Measure |
Sinus Lift Plus Dental Implant
n=13 participants at risk
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
n=13 participants at risk
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
|
|---|---|---|
|
General disorders
Lesion
|
7.7%
1/13 • Number of events 1 • 4 years
|
0.00%
0/13 • 4 years
|
|
General disorders
Bleeding
|
0.00%
0/13 • 4 years
|
7.7%
1/13 • Number of events 1 • 4 years
|
|
Infections and infestations
Infection
|
7.7%
1/13 • Number of events 1 • 4 years
|
0.00%
0/13 • 4 years
|
|
Injury, poisoning and procedural complications
Soft Tissue Opening
|
15.4%
2/13 • Number of events 2 • 4 years
|
0.00%
0/13 • 4 years
|
|
General disorders
Broken Tooth
|
15.4%
2/13 • Number of events 2 • 4 years
|
0.00%
0/13 • 4 years
|
|
General disorders
Suture Loss
|
0.00%
0/13 • 4 years
|
7.7%
1/13 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Vomitting
|
7.7%
1/13 • Number of events 1 • 4 years
|
15.4%
2/13 • Number of events 2 • 4 years
|
|
Skin and subcutaneous tissue disorders
Shingles
|
7.7%
1/13 • Number of events 1 • 4 years
|
0.00%
0/13 • 4 years
|
|
General disorders
Pain and Swelling
|
0.00%
0/13 • 4 years
|
15.4%
2/13 • Number of events 2 • 4 years
|
|
General disorders
Flap Mobility
|
7.7%
1/13 • Number of events 1 • 4 years
|
0.00%
0/13 • 4 years
|
|
General disorders
Sore Throat
|
0.00%
0/13 • 4 years
|
7.7%
1/13 • Number of events 1 • 4 years
|
|
General disorders
Non-restoreable Tooth
|
0.00%
0/13 • 4 years
|
7.7%
1/13 • Number of events 1 • 4 years
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/13 • 4 years
|
23.1%
3/13 • Number of events 3 • 4 years
|
|
General disorders
Headaches
|
0.00%
0/13 • 4 years
|
7.7%
1/13 • Number of events 1 • 4 years
|
|
General disorders
Oral Ulcer
|
7.7%
1/13 • Number of events 1 • 4 years
|
0.00%
0/13 • 4 years
|
|
General disorders
Tingling
|
0.00%
0/13 • 4 years
|
7.7%
1/13 • Number of events 1 • 4 years
|
|
General disorders
Lack of Bone
|
7.7%
1/13 • Number of events 1 • 4 years
|
7.7%
1/13 • Number of events 1 • 4 years
|
|
General disorders
Rash
|
7.7%
1/13 • Number of events 1 • 4 years
|
0.00%
0/13 • 4 years
|
|
General disorders
Pain
|
15.4%
2/13 • Number of events 2 • 4 years
|
7.7%
1/13 • Number of events 1 • 4 years
|
|
General disorders
Discomfort
|
0.00%
0/13 • 4 years
|
7.7%
1/13 • Number of events 1 • 4 years
|
|
General disorders
Prosthesis Came Off
|
46.2%
6/13 • Number of events 6 • 4 years
|
15.4%
2/13 • Number of events 2 • 4 years
|
|
Injury, poisoning and procedural complications
Swelling
|
0.00%
0/13 • 4 years
|
7.7%
1/13 • Number of events 1 • 4 years
|
|
General disorders
Sensitivity
|
0.00%
0/13 • 4 years
|
7.7%
1/13 • Number of events 1 • 4 years
|
|
General disorders
Tenderness
|
0.00%
0/13 • 4 years
|
7.7%
1/13 • Number of events 1 • 4 years
|
|
General disorders
Ovarian Ulcer Rupture
|
7.7%
1/13 • Number of events 1 • 4 years
|
0.00%
0/13 • 4 years
|
|
Injury, poisoning and procedural complications
Exostosis
|
0.00%
0/13 • 4 years
|
7.7%
1/13 • Number of events 1 • 4 years
|
|
Injury, poisoning and procedural complications
Perforations
|
0.00%
0/13 • 4 years
|
7.7%
1/13 • Number of events 1 • 4 years
|
Additional Information
Dr. William Giannobile, Chair Department of Periodontics and Oral Medicine
University of Michigan School of Dentistry
Phone: 734-763-2105
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place