Trial Outcomes & Findings for Ridge Preservation After Tooth Extraction Using Cortical Versus Cancellous Freeze Dried Bone Allograft (NCT NCT01588444)
NCT ID: NCT01588444
Last Updated: 2015-10-22
Results Overview
Histologic percentage of vital bone formation in bone cores
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
18-20 weeks after grafting
Results posted on
2015-10-22
Participant Flow
Participant milestones
| Measure |
Cancellous FDBA (LifeNet)
grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)
Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)
|
Cortical FDBA (LifeNet)
CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)
cortical FDBA: cortical mineralized freeze-dried bone allograft
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ridge Preservation After Tooth Extraction Using Cortical Versus Cancellous Freeze Dried Bone Allograft
Baseline characteristics by cohort
| Measure |
Cancellous FDBA (LifeNet)
n=20 Participants
grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)
Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)
|
Cortical FDBA (LifeNet)
n=20 Participants
CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)
cortical FDBA: cortical mineralized freeze-dried bone allograft
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.4 years
n=99 Participants
|
55.6 years
n=107 Participants
|
54 years
n=206 Participants
|
|
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
|
17 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
20 participants
n=107 Participants
|
40 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 18-20 weeks after graftingHistologic percentage of vital bone formation in bone cores
Outcome measures
| Measure |
Cancellous FDBA (LifeNet)
n=20 Participants
grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)
Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)
|
Cortical FDBA (LifeNet)
n=20 Participants
CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)
cortical FDBA: cortical mineralized freeze-dried bone allograft
|
|---|---|---|
|
Histologic Percentage of Vital Bone Formation
|
12.98 percentage of vital bone
Interval 10.06 to 31.04
|
16.08 percentage of vital bone
Interval 12.12 to 30.25
|
Adverse Events
Cancellous FDBA (LifeNet)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cortical FDBA (LifeNet)
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