Trial Outcomes & Findings for Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts (NCT NCT02515058)
NCT ID: NCT02515058
Last Updated: 2018-01-23
Results Overview
histologic determination of % of vital bone formation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
3 months after ridge preservation
Results posted on
2018-01-23
Participant Flow
After enrollment, one subject was withdrawn as a screen failure. This left a total of 43 subjects enrolled to take part in the study
Participant milestones
| Measure |
Non-Freeze-Dried Bone Allograft (PUROS)
Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)
PUROS (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction
|
Freeze-Dried Bone Allograft (FDBA)
Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)
FDBA (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
22
|
|
Overall Study
COMPLETED
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts
Baseline characteristics by cohort
| Measure |
Non-Freeze-Dried Bone Allograft (PUROS)
n=21 Participants
Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)
PUROS (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction
|
Freeze-Dried Bone Allograft (FDBA)
n=22 Participants
Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)
FDBA (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 months after ridge preservationhistologic determination of % of vital bone formation
Outcome measures
| Measure |
Non-Freeze-Dried Bone Allograft (PUROS)
n=17 Participants
Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)
PUROS (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction
|
Freeze-Dried Bone Allograft (FDBA)
n=20 Participants
Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)
FDBA (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction
|
|---|---|---|
|
% Vital Bone Formation (Histological)
|
27.19 percentage
Standard Deviation 17.5
|
24.08 percentage
Standard Deviation 12.49
|
SECONDARY outcome
Timeframe: 3 months after ridge preservationhistologic determination of % of residual bone graft material
Outcome measures
| Measure |
Non-Freeze-Dried Bone Allograft (PUROS)
n=17 Participants
Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)
PUROS (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction
|
Freeze-Dried Bone Allograft (FDBA)
n=20 Participants
Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)
FDBA (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction
|
|---|---|---|
|
% Residual Graft Material (Histological)
|
23.38 percentage
Standard Deviation 13.45
|
22.96 percentage
Standard Deviation 21.04
|
Adverse Events
Non-Freeze-Dried Bone Allograft (PUROS)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Freeze-Dried Bone Allograft (FDBA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Non-Freeze-Dried Bone Allograft (PUROS)
n=21 participants at risk
Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)
PUROS (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction
|
Freeze-Dried Bone Allograft (FDBA)
n=22 participants at risk
Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)
FDBA (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction
|
|---|---|---|
|
Injury, poisoning and procedural complications
Head trauma
|
4.8%
1/21 • Number of events 1 • 20 months
|
0.00%
0/22 • 20 months
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Brian Mealey
UT Health Science Center at San Antonio
Phone: 210-567-3567
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place