Trial Outcomes & Findings for Comparison of Post Tooth Extraction Healing Using Different Xenograft Materials (NCT NCT03149172)
NCT ID: NCT03149172
Last Updated: 2020-09-25
Results Overview
Histomorphometric determination of % new bone formation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
4-6 months after ridge preservation surgery
Results posted on
2020-09-25
Participant Flow
25 subjects were screened. However, only 21 subjects were enrolled. 4 patients didn't participate the study.
Participant milestones
| Measure |
Equimatrix®
Equimatrix® + Mucograft or alternatives
Equimatrix®: Ridge preservation bone grafting after tooth extraction
|
Bio-Oss®
Bio-Oss® + Mucograft or alternatives
Bio-Oss®: Ridge preservation bone grafting after tooth extraction
|
Endobon®
Endobon® + Mucograft or alternatives
Endobon®: Ridge preservation bone grafting after tooth extraction
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
7
|
|
Overall Study
COMPLETED
|
6
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Post Tooth Extraction Healing Using Different Xenograft Materials
Baseline characteristics by cohort
| Measure |
Equimatrix®
n=8 Participants
Equimatrix® + Mucograft or alternatives
Equimatrix®: Ridge preservation bone grafting after tooth extraction
|
Bio-Oss®
n=6 Participants
Bio-Oss® + Mucograft or alternatives
Bio-Oss®: Ridge preservation bone grafting after tooth extraction
|
Endobon®
n=7 Participants
Endobon® + Mucograft or alternatives
Endobon®: Ridge preservation bone grafting after tooth extraction
|
Total
n=21 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
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 8.7 • n=99 Participants
|
55.2 years
STANDARD_DEVIATION 12.6 • n=107 Participants
|
53.5 years
STANDARD_DEVIATION 7.1 • n=206 Participants
|
56.7 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
6 participants
n=107 Participants
|
7 participants
n=206 Participants
|
21 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 4-6 months after ridge preservation surgeryHistomorphometric determination of % new bone formation
Outcome measures
| Measure |
Equimatrix®
n=6 Participants
Equimatrix® + Mucograft or alternatives
Equimatrix®: Ridge preservation bone grafting after tooth extraction
|
Bio-Oss®
n=5 Participants
Bio-Oss® + Mucograft or alternatives
Bio-Oss®: Ridge preservation bone grafting after tooth extraction
|
Endobon®
n=5 Participants
Endobon® + Mucograft or alternatives
Endobon®: Ridge preservation bone grafting after tooth extraction
|
|---|---|---|---|
|
Percent New Bone Formation
|
41 percentage of new bone formation
Standard Deviation 30
|
25 percentage of new bone formation
Standard Deviation 18
|
26 percentage of new bone formation
Standard Deviation 26
|
SECONDARY outcome
Timeframe: 4-6 months after ridge preservation surgeryPopulation: The micro-CT data was anaylzed as a preliminary outcome of the primary outcome. A total of 10 patient data was used.
Measured by Micro CT Scanning
Outcome measures
| Measure |
Equimatrix®
n=3 Participants
Equimatrix® + Mucograft or alternatives
Equimatrix®: Ridge preservation bone grafting after tooth extraction
|
Bio-Oss®
n=3 Participants
Bio-Oss® + Mucograft or alternatives
Bio-Oss®: Ridge preservation bone grafting after tooth extraction
|
Endobon®
n=4 Participants
Endobon® + Mucograft or alternatives
Endobon®: Ridge preservation bone grafting after tooth extraction
|
|---|---|---|---|
|
Bone Density
|
25.6 percentage of bone volume
Standard Deviation 18.7
|
23.0 percentage of bone volume
Standard Deviation 7.9
|
12.9 percentage of bone volume
Standard Deviation 11.1
|
Adverse Events
Equimatrix®
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bio-Oss®
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Endobon®
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