Trial Outcomes & Findings for Bone Remodeling After Immediate Implant Placement With and Without Bone Grafting (NCT NCT02174198)
NCT ID: NCT02174198
Last Updated: 2019-06-13
Results Overview
The horizontal dimensional change from a digital superimposition at 3mm apical to the baseline free gingival margin position was measured.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Baseline and 12 months
Results posted on
2019-06-13
Participant Flow
Participant milestones
| Measure |
BioOss Collagen
Intervention: BioOss Collagen at the time of implant placement
BioOss Collagen at the time of implant placement: Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen
|
No Bone Graft
No placement of BioOss at the time of implant placement
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bone Remodeling After Immediate Implant Placement With and Without Bone Grafting
Baseline characteristics by cohort
| Measure |
BioOss Collagen
n=16 Participants
Intervention: BioOss Collagen at the time of implant placement
BioOss Collagen at the time of implant placement: Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen
|
No Bone Graft
n=16 Participants
No placement of BioOss at the time of implant placement
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 3.3 • n=7 Participants
|
52.3 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Number of Smokers
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsThe horizontal dimensional change from a digital superimposition at 3mm apical to the baseline free gingival margin position was measured.
Outcome measures
| Measure |
BioOss Collagen
n=16 Participants
Intervention: BioOss Collagen at the time of implant placement
BioOss Collagen at the time of implant placement: Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen
|
No Bone Graft
n=16 Participants
No placement of BioOss at the time of implant placement
|
|---|---|---|
|
Mean Bucco-Lingual Change at 3mm
|
-0.84 mm
Standard Deviation 0.64
|
-1.01 mm
Standard Deviation 0.45
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsThe horizontal dimensional change from a digital superimposition at 4mm apical to the baseline free gingival margin position was measured.
Outcome measures
| Measure |
BioOss Collagen
n=16 Participants
Intervention: BioOss Collagen at the time of implant placement
BioOss Collagen at the time of implant placement: Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen
|
No Bone Graft
n=16 Participants
No placement of BioOss at the time of implant placement
|
|---|---|---|
|
Mean Bucco-Lingual Change at 4mm
|
-0.64 mm
Standard Deviation 0.62
|
-0.80 mm
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsThe mean change was calculated from a tooth-supported stent to the free gingival margin.
Outcome measures
| Measure |
BioOss Collagen
n=16 Participants
Intervention: BioOss Collagen at the time of implant placement
BioOss Collagen at the time of implant placement: Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen
|
No Bone Graft
n=16 Participants
No placement of BioOss at the time of implant placement
|
|---|---|---|
|
Change in Vertical Dimension of Buccal Soft Tissue (Distal Papilla)
|
-0.4 mm
Standard Deviation 1.2
|
-1.4 mm
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsThe mean change was calculated from a tooth-supported stent to the free gingival margin.
Outcome measures
| Measure |
BioOss Collagen
n=16 Participants
Intervention: BioOss Collagen at the time of implant placement
BioOss Collagen at the time of implant placement: Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen
|
No Bone Graft
n=16 Participants
No placement of BioOss at the time of implant placement
|
|---|---|---|
|
Change in Vertical Dimension of Buccal Soft Tissue (Mid-buccal)
|
-0.9 mm
Standard Deviation 1.2
|
-1.3 mm
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsThe mean change was calculated from a tooth-supported stent to the free gingival margin.
Outcome measures
| Measure |
BioOss Collagen
n=16 Participants
Intervention: BioOss Collagen at the time of implant placement
BioOss Collagen at the time of implant placement: Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen
|
No Bone Graft
n=16 Participants
No placement of BioOss at the time of implant placement
|
|---|---|---|
|
Change in Vertical Dimension of Buccal Soft Tissue (Mesial Papilla)
|
-0.6 mm
Standard Deviation 1.2
|
-0.9 mm
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data for this outcome measure was not collected and analyzed since all the patients on the study were periodontally healthy and showed no signs of soft tissue inflammation.
The periodontal probing depth will be measured in mm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsTissue thickness was measured at 3mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper.
Outcome measures
| Measure |
BioOss Collagen
n=16 Participants
Intervention: BioOss Collagen at the time of implant placement
BioOss Collagen at the time of implant placement: Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen
|
No Bone Graft
n=16 Participants
No placement of BioOss at the time of implant placement
|
|---|---|---|
|
Thickness of Keratinized Tissue at 3mm
|
1.7 mm
Standard Deviation 0.6
|
1.7 mm
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 12 monthsTissue thickness was measured at 4mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper.
Outcome measures
| Measure |
BioOss Collagen
n=16 Participants
Intervention: BioOss Collagen at the time of implant placement
BioOss Collagen at the time of implant placement: Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen
|
No Bone Graft
n=16 Participants
No placement of BioOss at the time of implant placement
|
|---|---|---|
|
Thickness of Keratinized Tissue at 4mm
|
1.4 mm
Standard Deviation 0.4
|
1.6 mm
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 12 monthsTissue thickness was measured at 8mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper.
Outcome measures
| Measure |
BioOss Collagen
n=16 Participants
Intervention: BioOss Collagen at the time of implant placement
BioOss Collagen at the time of implant placement: Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen
|
No Bone Graft
n=16 Participants
No placement of BioOss at the time of implant placement
|
|---|---|---|
|
Thickness of Keratinized Tissue at 8mm
|
1.5 mm
Standard Deviation 0.5
|
1.8 mm
Standard Deviation 0.8
|
Adverse Events
BioOss Collagen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Bone Graft
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place