Trial Outcomes & Findings for Comparative Volumetric Assessment of Alveolar Ridge Preservation Utilizing Different Bone Grafting Materials (NCT NCT02532543)
NCT ID: NCT02532543
Last Updated: 2019-12-09
Results Overview
The change in bone volume at 3 months following extraction will be calculated using data from DICOM images acquired by Cone Beam Computed Tomography (CBCT) using 3D software
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
time of extraction to 3 months post extraction
Results posted on
2019-12-09
Participant Flow
Participant milestones
| Measure |
Group A- Allograft, Membrane
Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
Allograft, Membrane: Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
|
Group B- Alloplast, Membrane
Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
Alloplast, Membrane: Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
|
Group C- Xenograft, Membrane
OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane
Xenograft, Membrane: Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane
|
Group D- Membrane
Symbios OsteoShield Collagen Resorbable Membrane
Membrane: Membrane - Symbios OsteoShield Collagen Resorbable Membrane
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
5
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group A- Allograft, Membrane
Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
Allograft, Membrane: Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
|
Group B- Alloplast, Membrane
Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
Alloplast, Membrane: Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
|
Group C- Xenograft, Membrane
OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane
Xenograft, Membrane: Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane
|
Group D- Membrane
Symbios OsteoShield Collagen Resorbable Membrane
Membrane: Membrane - Symbios OsteoShield Collagen Resorbable Membrane
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group A- Allograft, Membrane
n=3 Participants
Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
Allograft, Membrane: Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
|
Group B- Alloplast, Membrane
n=4 Participants
Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
Alloplast, Membrane: Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
|
Group C- Xenograft, Membrane
n=5 Participants
OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane
Xenograft, Membrane: Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane
|
Group D- Membrane
n=4 Participants
Symbios OsteoShield Collagen Resorbable Membrane
Membrane: Membrane - Symbios OsteoShield Collagen Resorbable Membrane
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.3 years
STANDARD_DEVIATION 4.5 • n=3 Participants
|
63.2 years
STANDARD_DEVIATION 5.7 • n=4 Participants
|
49.2 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
50.7 years
STANDARD_DEVIATION 20.7 • n=4 Participants
|
53.0 years
STANDARD_DEVIATION 13.3 • n=16 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=16 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
3 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: time of extraction to 3 months post extractionPopulation: One participant was lost to follow up.
The change in bone volume at 3 months following extraction will be calculated using data from DICOM images acquired by Cone Beam Computed Tomography (CBCT) using 3D software
Outcome measures
| Measure |
Group A- Allograft, Membrane
n=3 Participants
Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
Allograft, Membrane: Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
|
Group B- Alloplast, Membrane
n=4 Participants
Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
Alloplast, Membrane: Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
|
Group C- Xenograft, Membrane
n=4 Participants
OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane
Xenograft, Membrane: Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane
|
Group D- Membrane
n=4 Participants
Symbios OsteoShield Collagen Resorbable Membrane
Membrane: Membrane - Symbios OsteoShield Collagen Resorbable Membrane
|
|---|---|---|---|---|
|
Total Mean Change in Bone Volume
|
-91.64 mm^3
Standard Deviation 51.97
|
-107.47 mm^3
Standard Deviation 52.31
|
-77.31 mm^3
Standard Deviation 30.99
|
-99.41 mm^3
Standard Deviation 66.00
|
SECONDARY outcome
Timeframe: time of extraction to 3 months post extractionPopulation: One participant was lost to follow up. Measurements were taken at 2 and 4 mm instead of 3, 6 and 9 mm due to difficulties in data collection and patient variability
The amount of linear (mm) horizontal bone change at 3 months following tooth extraction at a position located 2mm and 4mm vertically away from the height of the buccal plate. Data will be calculated using data from DICOM images acquired by CBCT using 3D software.
Outcome measures
| Measure |
Group A- Allograft, Membrane
n=3 Participants
Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
Allograft, Membrane: Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
|
Group B- Alloplast, Membrane
n=4 Participants
Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
Alloplast, Membrane: Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
|
Group C- Xenograft, Membrane
n=4 Participants
OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane
Xenograft, Membrane: Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane
|
Group D- Membrane
n=4 Participants
Symbios OsteoShield Collagen Resorbable Membrane
Membrane: Membrane - Symbios OsteoShield Collagen Resorbable Membrane
|
|---|---|---|---|---|
|
Mean Osseous Dimensional Changes-Horizontal
2 mm from height of crest
|
-0.87 mm
Standard Deviation 0.98
|
-1.30 mm
Standard Deviation 0.74
|
-1.77 mm
Standard Deviation 0.42
|
-1.62 mm
Standard Deviation 1.75
|
|
Mean Osseous Dimensional Changes-Horizontal
4 mm from height of crest
|
-1.03 mm
Standard Deviation 0.80
|
-0.47 mm
Standard Deviation 0.57
|
-0.92 mm
Standard Deviation 0.75
|
-0.97 mm
Standard Deviation 1.48
|
SECONDARY outcome
Timeframe: time of extraction to 3 months post extractionPopulation: One participant was lost to follow up.
The amount of linear (mm) vertical bone change at 3 months following tooth extraction at a position located mid-buccal, mid-palatal, mesial and distal of the extraction site. Data will be calculated using data from DICOM images acquired by CBCT using 3D software.
Outcome measures
| Measure |
Group A- Allograft, Membrane
n=3 Participants
Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
Allograft, Membrane: Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
|
Group B- Alloplast, Membrane
n=4 Participants
Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
Alloplast, Membrane: Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
|
Group C- Xenograft, Membrane
n=4 Participants
OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane
Xenograft, Membrane: Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane
|
Group D- Membrane
n=4 Participants
Symbios OsteoShield Collagen Resorbable Membrane
Membrane: Membrane - Symbios OsteoShield Collagen Resorbable Membrane
|
|---|---|---|---|---|
|
Mean Osseous Dimensional Changes-Vertical
Distal
|
-1.07 mm
Standard Deviation 0.25
|
-0.55 mm
Standard Deviation 0.46
|
-0.60 mm
Standard Deviation 1.07
|
-0.90 mm
Standard Deviation 0.62
|
|
Mean Osseous Dimensional Changes-Vertical
Mid Buccal
|
-1.23 mm
Standard Deviation 1.04
|
-1.77 mm
Standard Deviation 1.58
|
-2.00 mm
Standard Deviation 1.15
|
-2.92 mm
Standard Deviation 3.14
|
|
Mean Osseous Dimensional Changes-Vertical
Mid Palatal
|
-1.00 mm
Standard Deviation 0.40
|
-1.02 mm
Standard Deviation 0.39
|
-0.97 mm
Standard Deviation 0.46
|
-1.02 mm
Standard Deviation 0.82
|
|
Mean Osseous Dimensional Changes-Vertical
Mesial
|
-1.47 mm
Standard Deviation 0.55
|
-0.87 mm
Standard Deviation 0.69
|
-0.65 mm
Standard Deviation 1.14
|
-1.60 mm
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: time of extraction to 3 months post extractionPopulation: One participant was lost to follow up.
The change in soft tissue volume at 3 months following tooth extraction will be assessed through the use of 3D scans of patient dental models at two time points following extraction and ridge preservation at 3 months.
Outcome measures
| Measure |
Group A- Allograft, Membrane
n=3 Participants
Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
Allograft, Membrane: Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
|
Group B- Alloplast, Membrane
n=4 Participants
Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
Alloplast, Membrane: Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
|
Group C- Xenograft, Membrane
n=4 Participants
OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane
Xenograft, Membrane: Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane
|
Group D- Membrane
n=4 Participants
Symbios OsteoShield Collagen Resorbable Membrane
Membrane: Membrane - Symbios OsteoShield Collagen Resorbable Membrane
|
|---|---|---|---|---|
|
Total Mean Change in Soft Tissue Volume
|
-99.44 mm^3
Standard Deviation 48.93
|
-81.24 mm^3
Standard Deviation 13.24
|
-82.71 mm^3
Standard Deviation 23.15
|
-107.59 mm^3
Standard Deviation 38.59
|
SECONDARY outcome
Timeframe: time of extraction to 3 months post extractionPopulation: One participant was lost to follow up. Measurements were taken at 2 and 4 mm instead of 3, 6 and 9 mm due to difficulties in data collection and patient variability
The amount of linear (mm) horizontal soft tissue change at 3 months following tooth extraction at a position located 2mm and 4mm vertically away from the height of the buccal bone plate. Data will be calculated using data from DICOM images acquired by CBCT and overlaid 3D scans of patient dental models using 3D software.
Outcome measures
| Measure |
Group A- Allograft, Membrane
n=3 Participants
Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
Allograft, Membrane: Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
|
Group B- Alloplast, Membrane
n=4 Participants
Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
Alloplast, Membrane: Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
|
Group C- Xenograft, Membrane
n=4 Participants
OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane
Xenograft, Membrane: Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane
|
Group D- Membrane
n=4 Participants
Symbios OsteoShield Collagen Resorbable Membrane
Membrane: Membrane - Symbios OsteoShield Collagen Resorbable Membrane
|
|---|---|---|---|---|
|
Mean Soft Tissue Dimensional Changes-Horizontal
2 mm from height of crest
|
-0.47 mm
Standard Deviation 0.47
|
-0.67 mm
Standard Deviation 0.48
|
-1.30 mm
Standard Deviation 0.82
|
-0.87 mm
Standard Deviation 0.95
|
|
Mean Soft Tissue Dimensional Changes-Horizontal
4 mm from height of crest
|
-0.40 mm
Standard Deviation 0.28
|
-0.37 mm
Standard Deviation 0.25
|
-0.70 mm
Standard Deviation 0.47
|
-0.50 mm
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: time of extraction to 3 months post extractionPopulation: One participant was lost to follow up.
The amount of linear (mm) vertical soft tissue change at 3 months following tooth extraction at a position located mid-buccal, mid-palatal, mesial and distal of the extraction site. Data will be calculated using data from 3D scans of patient dental models using 3D software.
Outcome measures
| Measure |
Group A- Allograft, Membrane
n=3 Participants
Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
Allograft, Membrane: Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
|
Group B- Alloplast, Membrane
n=4 Participants
Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
Alloplast, Membrane: Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
|
Group C- Xenograft, Membrane
n=4 Participants
OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane
Xenograft, Membrane: Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane
|
Group D- Membrane
n=4 Participants
Symbios OsteoShield Collagen Resorbable Membrane
Membrane: Membrane - Symbios OsteoShield Collagen Resorbable Membrane
|
|---|---|---|---|---|
|
Mean Soft Tissue Dimensional Changes-Vertical
Mid Buccal
|
-1.60 mm
Standard Deviation 1.15
|
-1.80 mm
Standard Deviation 0.62
|
-1.72 mm
Standard Deviation 0.51
|
-2.95 mm
Standard Deviation 1.75
|
|
Mean Soft Tissue Dimensional Changes-Vertical
Mid Palatal
|
-1.20 mm
Standard Deviation 0.36
|
-1.00 mm
Standard Deviation 0.29
|
-1.02 mm
Standard Deviation 0.68
|
-1.30 mm
Standard Deviation 0.58
|
|
Mean Soft Tissue Dimensional Changes-Vertical
Mesial
|
-1.30 mm
Standard Deviation 1.04
|
-1.02 mm
Standard Deviation 0.45
|
-0.52 mm
Standard Deviation 0.59
|
-1.37 mm
Standard Deviation 0.15
|
|
Mean Soft Tissue Dimensional Changes-Vertical
Distal
|
-1.53 mm
Standard Deviation 1.00
|
-1.05 mm
Standard Deviation 0.66
|
-1.12 mm
Standard Deviation 0.89
|
-1.47 mm
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Month 6Population: Data for the Month 6 timepoint was not collected
The amount of soft tissue change will be assessed through the use of dental casts at two time points following extraction and ridge preservation at 6 months.
Outcome measures
Outcome data not reported
Adverse Events
Group A- Allograft, Membrane
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B- Alloplast, Membrane
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group C- Xenograft, Membrane
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group D- Membrane
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Gidgetta Kang
University of North Carolina at Chapel Hill
Phone: 919-537-3968
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place