Trial Outcomes & Findings for Dental Implant Study Comparing Two Types of Metals Used for Dental Implants (NCT NCT01714024)
NCT ID: NCT01714024
Last Updated: 2017-10-12
Results Overview
Samples were analyzed comparing the osteogenic potential associated with titanium and porous tantalum dental implants (cylinders) at 2 and 4 weeks using transcriptome analyses. The primary outcome data are displayed showing the Average Delta ∆ (Ct) for osteogenic genes relative to the housekeeping markers. The numerical value of the CT is inversely related to the amount of amplicon in the reaction (i.e., the lower the CT, the greater the amount of amplicon).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
2 weeks & 4 weeks post placement
Results posted on
2017-10-12
Participant Flow
Participant milestones
| Measure |
Healthy Volunteers
Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.
Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
|
Diabetic Subjects
Subjects must have Type 2 diabetes mellitus as diagnosed by a physician or in medication history. The condition must be currently diagnosed and treated by medications and/or insulin.
Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
|
Osteopenic Subjects
Subjects must be diagnosed with osteoporosis or osteopenia and must be currently under the care of a physician and treatment with oral bisphosphonates
Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
18
|
11
|
|
Overall Study
COMPLETED
|
12
|
12
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dental Implant Study Comparing Two Types of Metals Used for Dental Implants
Baseline characteristics by cohort
| Measure |
Healthy Volunteers
n=12 Participants
Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.
Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
|
Diabetic Subjects
n=12 Participants
Subjects must have Type 2 diabetes mellitus as diagnosed by a physician or in medication history. The condition must be currently diagnosed and treated by medications and/or insulin.
Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
|
Osteopenic Subjects
n=8 Participants
Subjects must be diagnosed with osteoporosis or osteopenia and must be currently under the care of a physician and treatment with oral bisphosphonates
Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Age, Continuous
|
59.33 years
n=5 Participants
|
64.33 years
n=7 Participants
|
66.38 years
n=5 Participants
|
64.22 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
36 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 weeks & 4 weeks post placementSamples were analyzed comparing the osteogenic potential associated with titanium and porous tantalum dental implants (cylinders) at 2 and 4 weeks using transcriptome analyses. The primary outcome data are displayed showing the Average Delta ∆ (Ct) for osteogenic genes relative to the housekeeping markers. The numerical value of the CT is inversely related to the amount of amplicon in the reaction (i.e., the lower the CT, the greater the amount of amplicon).
Outcome measures
| Measure |
Healthy/Tantalum
n=12 Participants
Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.
For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks.
|
Healthy/Titanium
n=12 Participants
Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.
For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks.
|
Osteopenic/Tantalum
n=8 Participants
Subjects must be diagnosed with osteoporosis or osteopenia, non-diabetic, with no history of smoking within the past two years
For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks.
|
Osteopenic/Titanium
n=8 Participants
Subjects must be diagnosed with osteoporosis or osteopenia, non-diabetic, with no history of smoking within the past two years
For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks.
|
Diabetic/Tantalum
n=12 Participants
Subjects who are diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis
For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks.
|
Diabetic/Titanium
n=12 Participants
Subjects who are diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis
For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks.
|
|---|---|---|---|---|---|---|
|
Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium.
BMP2 (2 weeks)
|
7.6758 Average Delta ∆ (Ct)
Standard Deviation 0.12
|
9.2208 Average Delta ∆ (Ct)
Standard Deviation 1.15
|
4.6085 Average Delta ∆ (Ct)
Standard Deviation 2.67
|
5.2331 Average Delta ∆ (Ct)
Standard Deviation 1.69
|
7.1463 Average Delta ∆ (Ct)
Standard Deviation 1.67
|
6.5207 Average Delta ∆ (Ct)
Standard Deviation 1.73
|
|
Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium.
DLX5 (2 week)
|
10.4258 Average Delta ∆ (Ct)
Standard Deviation .038
|
12.2275 Average Delta ∆ (Ct)
Standard Deviation 1.08
|
5.9966 Average Delta ∆ (Ct)
Standard Deviation 1.56
|
6.1543 Average Delta ∆ (Ct)
Standard Deviation 1.75
|
9.4077 Average Delta ∆ (Ct)
Standard Deviation 1.09
|
9.4038 Average Delta ∆ (Ct)
Standard Deviation 1.12
|
|
Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium.
BMP1 (2 weeks)
|
4.2225 Average Delta ∆ (Ct)
Standard Deviation 0.46
|
5.9042 Average Delta ∆ (Ct)
Standard Deviation 0.84
|
1.8624 Average Delta ∆ (Ct)
Standard Deviation 1.49
|
2.4895 Average Delta ∆ (Ct)
Standard Deviation 1.31
|
3.9986 Average Delta ∆ (Ct)
Standard Deviation 1.77
|
3.5056 Average Delta ∆ (Ct)
Standard Deviation 1.57
|
|
Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium.
BGN (2 Weeks)
|
0.6525 Average Delta ∆ (Ct)
Standard Deviation 0.63
|
3.0942 Average Delta ∆ (Ct)
Standard Deviation 1.25
|
-1.9201 Average Delta ∆ (Ct)
Standard Deviation 0.31
|
-0.6761 Average Delta ∆ (Ct)
Standard Deviation 0.22
|
0.9032 Average Delta ∆ (Ct)
Standard Deviation 1.86
|
.03906 Average Delta ∆ (Ct)
Standard Deviation 2.30
|
|
Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium.
COL14A1 (2 weeks)
|
2.9192 Average Delta ∆ (Ct)
Standard Deviation 0.52
|
4.4442 Average Delta ∆ (Ct)
Standard Deviation 0.33
|
0.5529 Average Delta ∆ (Ct)
Standard Deviation 0.42
|
0.9162 Average Delta ∆ (Ct)
Standard Deviation 0.66
|
2.4111 Average Delta ∆ (Ct)
Standard Deviation 1.31
|
3.0112 Average Delta ∆ (Ct)
Standard Deviation 1.18
|
|
Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium.
CSF1 (2 weeks)
|
5.2292 Average Delta ∆ (Ct)
Standard Deviation 0.51
|
6.4042 Average Delta ∆ (Ct)
Standard Deviation 0.23
|
0.8180 Average Delta ∆ (Ct)
Standard Deviation 0.95
|
2.1533 Average Delta ∆ (Ct)
Standard Deviation 0.81
|
4.5506 Average Delta ∆ (Ct)
Standard Deviation 1.39
|
4.6397 Average Delta ∆ (Ct)
Standard Deviation 1.21
|
|
Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium.
GLI1 (4 weeks)
|
5.7365 Average Delta ∆ (Ct)
Standard Deviation 0.27
|
8.2807 Average Delta ∆ (Ct)
Standard Deviation 0.23
|
4.8091 Average Delta ∆ (Ct)
Standard Deviation 0.33
|
4.7381 Average Delta ∆ (Ct)
Standard Deviation 1.41
|
8.7988 Average Delta ∆ (Ct)
Standard Deviation 3.77
|
9.1999 Average Delta ∆ (Ct)
Standard Deviation 2.04
|
|
Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium.
IGF1R (4 weeks)
|
1.5259 Average Delta ∆ (Ct)
Standard Deviation 0.31
|
3.8134 Average Delta ∆ (Ct)
Standard Deviation 1.08
|
2.6811 Average Delta ∆ (Ct)
Standard Deviation 1.08
|
3.0398 Average Delta ∆ (Ct)
Standard Deviation 0.30
|
5.6048 Average Delta ∆ (Ct)
Standard Deviation 2.31
|
6.3467 Average Delta ∆ (Ct)
Standard Deviation 0.65
|
|
Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium.
PHEX (4 weeks)
|
2.1578 Average Delta ∆ (Ct)
Standard Deviation 0.58
|
6.4186 Average Delta ∆ (Ct)
Standard Deviation 2.08
|
0.2916 Average Delta ∆ (Ct)
Standard Deviation 0.26
|
3.9890 Average Delta ∆ (Ct)
Standard Deviation 0.41
|
5.7960 Average Delta ∆ (Ct)
Standard Deviation 1.62
|
6.8678 Average Delta ∆ (Ct)
Standard Deviation 0.80
|
|
Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium.
FGF1 (4 weeks)
|
4.0907 Average Delta ∆ (Ct)
Standard Deviation 0.19
|
5.3543 Average Delta ∆ (Ct)
Standard Deviation 0.85
|
2.5977 Average Delta ∆ (Ct)
Standard Deviation 0.23
|
3.1967 Average Delta ∆ (Ct)
Standard Deviation 1.77
|
6.3124 Average Delta ∆ (Ct)
Standard Deviation 4.51
|
5.8513 Average Delta ∆ (Ct)
Standard Deviation 0.53
|
|
Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium.
FGFR2 (4 weeks)
|
1.5910 Average Delta ∆ (Ct)
Standard Deviation 0.38
|
3.8245 Average Delta ∆ (Ct)
Standard Deviation 1.98
|
0.8745 Average Delta ∆ (Ct)
Standard Deviation 0.10
|
2.9709 Average Delta ∆ (Ct)
Standard Deviation 0.34
|
4.3674 Average Delta ∆ (Ct)
Standard Deviation 2.19
|
5.4090 Average Delta ∆ (Ct)
Standard Deviation 0.71
|
|
Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium.
TGFBR2 (4weeks)
|
0.3029 Average Delta ∆ (Ct)
Standard Deviation 0.25
|
0.9102 Average Delta ∆ (Ct)
Standard Deviation 0.79
|
-0.9658 Average Delta ∆ (Ct)
Standard Deviation 1.74
|
-0.2509 Average Delta ∆ (Ct)
Standard Deviation 2.96
|
2.2868 Average Delta ∆ (Ct)
Standard Deviation 1.89
|
2.9935 Average Delta ∆ (Ct)
Standard Deviation 1.23
|
|
Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium.
FGF2 (4 weeks)
|
4.7981 Average Delta ∆ (Ct)
Standard Deviation 0.26
|
5.9102 Average Delta ∆ (Ct)
Standard Deviation 0.71
|
-0.9658 Average Delta ∆ (Ct)
Standard Deviation 1.33
|
4.2644 Average Delta ∆ (Ct)
Standard Deviation 1.97
|
6.8459 Average Delta ∆ (Ct)
Standard Deviation 3.20
|
7.7363 Average Delta ∆ (Ct)
Standard Deviation 1.34
|
|
Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium.
FGFR1 (4 weeks)
|
0.3229 Average Delta ∆ (Ct)
Standard Deviation 0.71
|
1.4584 Average Delta ∆ (Ct)
Standard Deviation 0.41
|
-0.5135 Average Delta ∆ (Ct)
Standard Deviation 0.20
|
-0.9003 Average Delta ∆ (Ct)
Standard Deviation 0.24
|
2.4234 Average Delta ∆ (Ct)
Standard Deviation 2.36
|
2.7818 Average Delta ∆ (Ct)
Standard Deviation 2.16
|
|
Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium.
IGF1 (4 weeks)
|
0.5603 Average Delta ∆ (Ct)
Standard Deviation 1.09
|
3.3670 Average Delta ∆ (Ct)
Standard Deviation 1.25
|
2.1275 Average Delta ∆ (Ct)
Standard Deviation 2.47
|
1.8615 Average Delta ∆ (Ct)
Standard Deviation 0.40
|
4.2738 Average Delta ∆ (Ct)
Standard Deviation 1.55
|
5.4869 Average Delta ∆ (Ct)
Standard Deviation 1.68
|
|
Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium.
BMP2 (4 weeks)
|
7.0738 Average Delta ∆ (Ct)
Standard Deviation 1.26
|
4.3821 Average Delta ∆ (Ct)
Standard Deviation 0.50
|
3.3444 Average Delta ∆ (Ct)
Standard Deviation 1.30
|
3.6476 Average Delta ∆ (Ct)
Standard Deviation 0.94
|
7.1463 Average Delta ∆ (Ct)
Standard Deviation 2.56
|
6.5207 Average Delta ∆ (Ct)
Standard Deviation 0.91
|
|
Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium.
BMP1 (4 weeks)
|
3.6543 Average Delta ∆ (Ct)
Standard Deviation 0.43
|
2.2410 Average Delta ∆ (Ct)
Standard Deviation 0.59
|
0.6949 Average Delta ∆ (Ct)
Standard Deviation 0.14
|
1.0592 Average Delta ∆ (Ct)
Standard Deviation 0.20
|
3.9986 Average Delta ∆ (Ct)
Standard Deviation 2.71
|
1.5697 Average Delta ∆ (Ct)
Standard Deviation 1.63
|
SECONDARY outcome
Timeframe: 4 weeksFindings from expression arrays will be used to perform quantitative PCR analyses using SAB Superarrays (SuperArray GEArray), to enable a quantitativeassay of mRNA levels of specific inflammatory and growth factor molecules
Outcome measures
| Measure |
Healthy/Tantalum
n=12 Participants
Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.
For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks.
|
Healthy/Titanium
n=12 Participants
Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.
For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks.
|
Osteopenic/Tantalum
n=12 Participants
Subjects must be diagnosed with osteoporosis or osteopenia, non-diabetic, with no history of smoking within the past two years
For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks.
|
Osteopenic/Titanium
n=12 Participants
Subjects must be diagnosed with osteoporosis or osteopenia, non-diabetic, with no history of smoking within the past two years
For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks.
|
Diabetic/Tantalum
n=8 Participants
Subjects who are diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis
For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks.
|
Diabetic/Titanium
n=8 Participants
Subjects who are diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis
For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders were implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two were removed at 4 weeks.
|
|---|---|---|---|---|---|---|
|
Group Based Differences (i.e. Healthy, Osteopenic and Diabetic) in Gene Expression Using Fold Changes Between Titanium and Trabecular at 4 Weeks.
PHEX
|
2.158 Fold Change
Standard Deviation 0.58
|
6.419 Fold Change
Standard Deviation 2.08
|
5.796 Fold Change
Standard Deviation 1.62
|
6.868 Fold Change
Standard Deviation 0.80
|
0.292 Fold Change
Standard Deviation 0.26
|
3.989 Fold Change
Standard Deviation 0.41
|
|
Group Based Differences (i.e. Healthy, Osteopenic and Diabetic) in Gene Expression Using Fold Changes Between Titanium and Trabecular at 4 Weeks.
FGF1
|
40.91 Fold Change
Standard Deviation 0.19
|
5.3454 Fold Change
Standard Deviation 0.85
|
6.312 Fold Change
Standard Deviation 4.51
|
5.851 Fold Change
Standard Deviation 0.53
|
2.598 Fold Change
Standard Deviation 0.23
|
3.197 Fold Change
Standard Deviation 1.77
|
|
Group Based Differences (i.e. Healthy, Osteopenic and Diabetic) in Gene Expression Using Fold Changes Between Titanium and Trabecular at 4 Weeks.
FGFR2
|
1.591 Fold Change
Standard Deviation 0.38
|
3.824 Fold Change
Standard Deviation 1.98
|
4.367 Fold Change
Standard Deviation 2019
|
5.409 Fold Change
Standard Deviation 0.71
|
0.875 Fold Change
Standard Deviation 0.10
|
2.971 Fold Change
Standard Deviation 0.34
|
|
Group Based Differences (i.e. Healthy, Osteopenic and Diabetic) in Gene Expression Using Fold Changes Between Titanium and Trabecular at 4 Weeks.
TGFBR2
|
0.303 Fold Change
Standard Deviation 0.25
|
0.901 Fold Change
Standard Deviation 0.79
|
2.287 Fold Change
Standard Deviation 1.89
|
2.994 Fold Change
Standard Deviation 1.23
|
-0.966 Fold Change
Standard Deviation 1.74
|
-0.251 Fold Change
Standard Deviation 2.96
|
|
Group Based Differences (i.e. Healthy, Osteopenic and Diabetic) in Gene Expression Using Fold Changes Between Titanium and Trabecular at 4 Weeks.
FGF2
|
4.79 Fold Change
Standard Deviation 0.26
|
5.910 Fold Change
Standard Deviation 0.71
|
6.846 Fold Change
Standard Deviation 3.20
|
7.736 Fold Change
Standard Deviation 1.34
|
-0.966 Fold Change
Standard Deviation 1.33
|
4.264 Fold Change
Standard Deviation 1.97
|
|
Group Based Differences (i.e. Healthy, Osteopenic and Diabetic) in Gene Expression Using Fold Changes Between Titanium and Trabecular at 4 Weeks.
FGFR1
|
0.323 Fold Change
Standard Deviation 0.71
|
1.458 Fold Change
Standard Deviation 0.41
|
2.423 Fold Change
Standard Deviation 2.36
|
2.782 Fold Change
Standard Deviation 2.16
|
-0.513 Fold Change
Standard Deviation 0.20
|
-0.9 Fold Change
Standard Deviation 0.24
|
|
Group Based Differences (i.e. Healthy, Osteopenic and Diabetic) in Gene Expression Using Fold Changes Between Titanium and Trabecular at 4 Weeks.
IGF1
|
0.56 Fold Change
Standard Deviation 1.09
|
3.367 Fold Change
Standard Deviation 1.25
|
4.2474 Fold Change
Standard Deviation 1.55
|
5.487 Fold Change
Standard Deviation 1.68
|
2.128 Fold Change
Standard Deviation 2.47
|
1.861 Fold Change
Standard Deviation 0.4
|
|
Group Based Differences (i.e. Healthy, Osteopenic and Diabetic) in Gene Expression Using Fold Changes Between Titanium and Trabecular at 4 Weeks.
BMP2
|
7.074 Fold Change
Standard Deviation 1.26
|
4.382 Fold Change
Standard Deviation 0.5
|
7.146 Fold Change
Standard Deviation 2.56
|
6.521 Fold Change
Standard Deviation 0.91
|
3.344 Fold Change
Standard Deviation 1.30
|
3.648 Fold Change
Standard Deviation 0.94
|
|
Group Based Differences (i.e. Healthy, Osteopenic and Diabetic) in Gene Expression Using Fold Changes Between Titanium and Trabecular at 4 Weeks.
BMP1
|
3.654 Fold Change
Standard Deviation 0.43
|
2.241 Fold Change
Standard Deviation 0.59
|
3.999 Fold Change
Standard Deviation 2.71
|
1.570 Fold Change
Standard Deviation 1.63
|
0.695 Fold Change
Standard Deviation 0.14
|
1.059 Fold Change
Standard Deviation 0.2
|
|
Group Based Differences (i.e. Healthy, Osteopenic and Diabetic) in Gene Expression Using Fold Changes Between Titanium and Trabecular at 4 Weeks.
CSF1
|
5.229 Fold Change
Standard Deviation 0.51
|
6.404 Fold Change
Standard Deviation 0.23
|
4.551 Fold Change
Standard Deviation 1.39
|
4.64 Fold Change
Standard Deviation 1.21
|
0.818 Fold Change
Standard Deviation 0.95
|
2.153 Fold Change
Standard Deviation 0.81
|
|
Group Based Differences (i.e. Healthy, Osteopenic and Diabetic) in Gene Expression Using Fold Changes Between Titanium and Trabecular at 4 Weeks.
GLI1
|
5.736 Fold Change
Standard Deviation 0.27
|
8.281 Fold Change
Standard Deviation 0.23
|
8.799 Fold Change
Standard Deviation 3.77
|
9.2 Fold Change
Standard Deviation 2.04
|
4.809 Fold Change
Standard Deviation 0.33
|
4.738 Fold Change
Standard Deviation 1.41
|
|
Group Based Differences (i.e. Healthy, Osteopenic and Diabetic) in Gene Expression Using Fold Changes Between Titanium and Trabecular at 4 Weeks.
IGF1R
|
1.526 Fold Change
Standard Deviation 0.31
|
3.813 Fold Change
Standard Deviation 1.08
|
5.605 Fold Change
Standard Deviation 2.31
|
6.347 Fold Change
Standard Deviation 0.65
|
2.681 Fold Change
Standard Deviation 1.08
|
3.04 Fold Change
Standard Deviation 0.30
|
Adverse Events
Healthy Volunteers
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Diabetic Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Osteopenic Subjects
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Volunteers
n=12 participants at risk
Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.
Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
|
Diabetic Subjects
n=12 participants at risk
Subjects must have Type 2 diabetes mellitus as diagnosed by a physician or in medication history. The condition must be currently diagnosed and treated by medications and/or insulin.
Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
|
Osteopenic Subjects
n=8 participants at risk
Subjects must be diagnosed with osteoporosis or osteopenia and must be currently under the care of a physician and treatment with oral bisphosphonates
Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
|
|---|---|---|---|
|
Infections and infestations
Gingival Swelling & Pain
|
16.7%
2/12 • Number of events 2 • 2 years, 4 months
|
0.00%
0/12 • 2 years, 4 months
|
12.5%
1/8 • Number of events 1 • 2 years, 4 months
|
|
General disorders
Delayed healing response
|
0.00%
0/12 • 2 years, 4 months
|
0.00%
0/12 • 2 years, 4 months
|
12.5%
1/8 • Number of events 1 • 2 years, 4 months
|
Additional Information
Steven Offenbacher, DDS, PhD, MMSc
UNC School of Dentistry
Phone: 919-537-3205
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place