Trial Outcomes & Findings for Ridge Preservation Following Tooth Extraction Using Porcine and Bovine Xenograft Materials (NCT NCT02802319)
NCT ID: NCT02802319
Last Updated: 2019-01-08
Results Overview
histologic determination of % vital bone formation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
18-20 weeks after ridge preservation
Results posted on
2019-01-08
Participant Flow
Participant milestones
| Measure |
Test: Porcine Xenograft (Zcore)
Ridge preservation bone grafting surgery with porcine xenograft (Zcore)
Porcine Xenograft (Zcore): Ridge preservation bone grafting after tooth extraction
|
Active Control: Bovine Xenograft (Bio-Oss)
Ridge preservation bone grafting surgery with bovine xenograft (Bio-Oss)
Bovine Xenograft (Bio-Oss): Ridge preservation bone grafting after tooth extraction
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
20
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Test: Porcine Xenograft (Zcore)
Ridge preservation bone grafting surgery with porcine xenograft (Zcore)
Porcine Xenograft (Zcore): Ridge preservation bone grafting after tooth extraction
|
Active Control: Bovine Xenograft (Bio-Oss)
Ridge preservation bone grafting surgery with bovine xenograft (Bio-Oss)
Bovine Xenograft (Bio-Oss): Ridge preservation bone grafting after tooth extraction
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
Baseline Characteristics
Ridge Preservation Following Tooth Extraction Using Porcine and Bovine Xenograft Materials
Baseline characteristics by cohort
| Measure |
Test: Porcine Xenograft (Zcore)
n=22 Participants
Ridge preservation bone grafting surgery with porcine xenograft (Zcore)
Porcine Xenograft (Zcore): Ridge preservation bone grafting after tooth extraction
|
Active Control: Bovine Xenograft (Bio-Oss)
n=22 Participants
Ridge preservation bone grafting surgery with bovine xenograft (Bio-Oss)
Bovine Xenograft (Bio-Oss): Ridge preservation bone grafting after tooth extraction
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
n=99 Participants
|
58 years
n=107 Participants
|
57 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
20 participants
n=107 Participants
|
41 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 18-20 weeks after ridge preservationhistologic determination of % vital bone formation
Outcome measures
| Measure |
Test: Porcine Xenograft (Zcore)
n=20 Participants
Ridge preservation bone grafting surgery with porcine xenograft (Zcore)
Porcine Xenograft (Zcore): Ridge preservation bone grafting after tooth extraction
|
Active Control: Bovine Xenograft (Bio-Oss)
n=17 Participants
Ridge preservation bone grafting surgery with bovine xenograft (Bio-Oss)
Bovine Xenograft (Bio-Oss): Ridge preservation bone grafting after tooth extraction
|
|---|---|---|
|
% Vital Bone Formation (Histological)
|
31.27 % vital bone
Standard Deviation 16.23
|
36.21 % vital bone
Standard Deviation 26.51
|
SECONDARY outcome
Timeframe: 18-20 weeks after ridge preservationhistologic determination of % residual bone graft material
Outcome measures
| Measure |
Test: Porcine Xenograft (Zcore)
n=20 Participants
Ridge preservation bone grafting surgery with porcine xenograft (Zcore)
Porcine Xenograft (Zcore): Ridge preservation bone grafting after tooth extraction
|
Active Control: Bovine Xenograft (Bio-Oss)
n=17 Participants
Ridge preservation bone grafting surgery with bovine xenograft (Bio-Oss)
Bovine Xenograft (Bio-Oss): Ridge preservation bone grafting after tooth extraction
|
|---|---|---|
|
% Residual Graft Material (Histological)
|
19.52 % residual graft material
Standard Deviation 9.19
|
20.47 % residual graft material
Standard Deviation 15.29
|
Adverse Events
Test: Porcine Xenograft (Zcore)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Active Control: Bovine Xenograft (Bio-Oss)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test: Porcine Xenograft (Zcore)
n=22 participants at risk
Ridge preservation bone grafting surgery with porcine xenograft (Zcore)
Porcine Xenograft (Zcore): Ridge preservation bone grafting after tooth extraction
|
Active Control: Bovine Xenograft (Bio-Oss)
n=22 participants at risk
Ridge preservation bone grafting surgery with bovine xenograft (Bio-Oss)
Bovine Xenograft (Bio-Oss): Ridge preservation bone grafting after tooth extraction
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Squamous cell carcinoma
|
0.00%
0/22 • 18 months
|
4.5%
1/22 • 18 months
|
Other adverse events
| Measure |
Test: Porcine Xenograft (Zcore)
n=22 participants at risk
Ridge preservation bone grafting surgery with porcine xenograft (Zcore)
Porcine Xenograft (Zcore): Ridge preservation bone grafting after tooth extraction
|
Active Control: Bovine Xenograft (Bio-Oss)
n=22 participants at risk
Ridge preservation bone grafting surgery with bovine xenograft (Bio-Oss)
Bovine Xenograft (Bio-Oss): Ridge preservation bone grafting after tooth extraction
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
fractured arm
|
4.5%
1/22 • Number of events 1 • 18 months
|
0.00%
0/22 • 18 months
|
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