Trial Outcomes & Findings for Histological Evaluation of Healing Following Ridge Preservation Using a Combined Cortical/Cancellous Mineralized Freeze-Dried Bone Allograft (NCT NCT02275767)
NCT ID: NCT02275767
Last Updated: 2016-05-11
Results Overview
histologic determination of % vital bone formation 18-20 weeks after ridge preservation surgery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
18-20 weeks after ridge preservation
Results posted on
2016-05-11
Participant Flow
Participant milestones
| Measure |
Combination 50% Cortical/50% Cancellous FDBA
Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)
50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA
|
100% Cortical FDBA
Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA
|
100% Cancellous FDBA
Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
22
|
|
Overall Study
COMPLETED
|
20
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Histological Evaluation of Healing Following Ridge Preservation Using a Combined Cortical/Cancellous Mineralized Freeze-Dried Bone Allograft
Baseline characteristics by cohort
| Measure |
Combination 50% Cortical/50% Cancellous FDBA
n=22 Participants
Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)
50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA
|
100% Cortical FDBA
n=22 Participants
Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA
|
100% Cancellous FDBA
n=22 Participants
Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.4 years
n=5 Participants
|
52.6 years
n=7 Participants
|
53.7 years
n=5 Participants
|
53.2 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 18-20 weeks after ridge preservationhistologic determination of % vital bone formation 18-20 weeks after ridge preservation surgery
Outcome measures
| Measure |
Combination 50% Cortical/50% Cancellous FDBA
n=20 Participants
Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)
50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA
|
100% Cortical FDBA
n=18 Participants
Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA
|
100% Cancellous FDBA
n=19 Participants
Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA
|
|---|---|---|---|
|
% Vital Bone Formation (Histological)
|
26.4 percentage of total area
Standard Deviation 13.2
|
24.5 percentage of total area
Standard Deviation 8.6
|
28.8 percentage of total area
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: 18-20 weeks after ridge preservationhistologic determination of % residual graft material 18-20 weeks after ridge preservation surgery
Outcome measures
| Measure |
Combination 50% Cortical/50% Cancellous FDBA
n=20 Participants
Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)
50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA
|
100% Cortical FDBA
n=18 Participants
Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA
|
100% Cancellous FDBA
n=19 Participants
Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA
|
|---|---|---|---|
|
% Residual Graft Material (Histological)
|
23.4 percentage of total area
Standard Deviation 12.5
|
28.1 percentage of total area
Standard Deviation 10.7
|
18.8 percentage of total area
Standard Deviation 8.4
|
Adverse Events
Combination 50% Cortical/50% Cancellous FDBA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
100% Cortical FDBA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
100% Cancellous FDBA
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
Brian L. Mealey DDS, MS
Univ of Texas Health Sci Ctr San Antonjio, Dept of Periodontics
Phone: 210-567-3567
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place