Trial Outcomes & Findings for A Histomorphometric Analysis Following Sinus Augmentation Using Two Different Bone Graft Materials. (NCT NCT03059914)
NCT ID: NCT03059914
Last Updated: 2024-05-01
Results Overview
Vital bone as seen in histology from the collected bone cores.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
8 months post operative after the initial sinus augmentation surgery.
Results posted on
2024-05-01
Participant Flow
The unit of enrollment here is one maxillary sinus that qualifies for grafting via lateral window approach. 9 patients were recruited who had 15 qualified maxillary sinus' in this study.
Unit of analysis: Sinus augmentation
Participant milestones
| Measure |
InterOss
Maxillary sinus augmentation using ABBM Inteross ( Xenograft)
InterOss: Anorganic bovine bone mineral - Xenograft
|
Bio-oss
Maxillary sinus augmentation using ABBM Bio-oss ( Xenograft)
Bio-oss: Anorganic bovine bone mineral ( Xenograft)
|
|---|---|---|
|
Overall Study
STARTED
|
4 6
|
5 9
|
|
Overall Study
COMPLETED
|
4 6
|
5 9
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The unit measured is the number of Maxillary sinus. The participants are number of people in the study. Some of the patients had one maxillary sinus that qualified for the study and some of the patients had both maxillary sinuses that qualified for the study.
Baseline characteristics by cohort
| Measure |
InterOss
n=6 Maxillary sinus
Maxillary sinus augmentation using ABBM Inteross ( Xenograft)
InterOss: Anorganic bovine bone mineral - Xenograft
|
Bio-oss
n=9 Maxillary sinus
Maxillary sinus augmentation using ABBM Bio-oss ( Xenograft)
Bio-oss: Anorganic bovine bone mineral ( Xenograft)
|
Total
n=15 Maxillary sinus
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.0 years
STANDARD_DEVIATION 4.1 • n=4 Participants
|
54.2 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 4.3 • n=9 Participants
|
|
Sex: Female, Male
Female
|
3 Maxillary sinus
n=6 Maxillary sinus • The unit measured is the number of Maxillary sinus. The participants are number of people in the study. Some of the patients had one maxillary sinus that qualified for the study and some of the patients had both maxillary sinuses that qualified for the study.
|
2 Maxillary sinus
n=9 Maxillary sinus • The unit measured is the number of Maxillary sinus. The participants are number of people in the study. Some of the patients had one maxillary sinus that qualified for the study and some of the patients had both maxillary sinuses that qualified for the study.
|
5 Maxillary sinus
n=15 Maxillary sinus • The unit measured is the number of Maxillary sinus. The participants are number of people in the study. Some of the patients had one maxillary sinus that qualified for the study and some of the patients had both maxillary sinuses that qualified for the study.
|
|
Sex: Female, Male
Male
|
3 Maxillary sinus
n=6 Maxillary sinus • The unit measured is the number of Maxillary sinus. The participants are number of people in the study. Some of the patients had one maxillary sinus that qualified for the study and some of the patients had both maxillary sinuses that qualified for the study.
|
7 Maxillary sinus
n=9 Maxillary sinus • The unit measured is the number of Maxillary sinus. The participants are number of people in the study. Some of the patients had one maxillary sinus that qualified for the study and some of the patients had both maxillary sinuses that qualified for the study.
|
10 Maxillary sinus
n=15 Maxillary sinus • The unit measured is the number of Maxillary sinus. The participants are number of people in the study. Some of the patients had one maxillary sinus that qualified for the study and some of the patients had both maxillary sinuses that qualified for the study.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
4 Participants
n=4 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 8 months post operative after the initial sinus augmentation surgery.Population: Subjects requiring sinus augmentation for implant placement
Vital bone as seen in histology from the collected bone cores.
Outcome measures
| Measure |
InterOss
n=6 Sinus
Maxillary sinus augmentation using ABBM Inteross ( Xenograft)
InterOss: Anorganic bovine bone mineral - Xenograft
|
Bio-oss
n=5 Participants
Maxillary sinus augmentation using ABBM Bio-oss ( Xenograft)
Bio-oss: Anorganic bovine bone mineral ( Xenograft)
|
|---|---|---|
|
Percentage of New Vital Bone.
Crestal core
|
30.5 percentage of new vital bone
Standard Deviation 5.86
|
39.67 percentage of new vital bone
Standard Deviation 3.52
|
|
Percentage of New Vital Bone.
Lateral core
|
16.33 percentage of new vital bone
Standard Deviation 8.43
|
26.11 percentage of new vital bone
Standard Deviation 11.63
|
SECONDARY outcome
Timeframe: Eight months post-op sinus augmentationPopulation: Subjects requiring sinus augmentation for implant placement
Cumulative percentage of Bone marrow and fibrous tissue as seen in histology.
Outcome measures
| Measure |
InterOss
n=4 Participants
Maxillary sinus augmentation using ABBM Inteross ( Xenograft)
InterOss: Anorganic bovine bone mineral - Xenograft
|
Bio-oss
n=5 Participants
Maxillary sinus augmentation using ABBM Bio-oss ( Xenograft)
Bio-oss: Anorganic bovine bone mineral ( Xenograft)
|
|---|---|---|
|
Cumulative Percentage of Bone Marrow and Fibrous Tissue
Lateral core
|
56.33 Cumulative percentage
Standard Deviation 5.57
|
51.67 Cumulative percentage
Standard Deviation 6.48
|
|
Cumulative Percentage of Bone Marrow and Fibrous Tissue
Crestal core
|
50.17 Cumulative percentage
Standard Deviation 5.53
|
46.33 Cumulative percentage
Standard Deviation 8.91
|
SECONDARY outcome
Timeframe: 8 monthsPopulation: Subjects requiring sinus augmentation for implant placement
Space seen the histology specimen not filled with either bone or fibrous tissue in the bone core specimens.
Outcome measures
| Measure |
InterOss
n=4 Participants
Maxillary sinus augmentation using ABBM Inteross ( Xenograft)
InterOss: Anorganic bovine bone mineral - Xenograft
|
Bio-oss
n=5 Participants
Maxillary sinus augmentation using ABBM Bio-oss ( Xenograft)
Bio-oss: Anorganic bovine bone mineral ( Xenograft)
|
|---|---|---|
|
Space
Lateral core
|
27.33 percentage of space not filled with bone
Standard Deviation 13.54
|
22.11 percentage of space not filled with bone
Standard Deviation 10.15
|
|
Space
Crestal core
|
19.5 percentage of space not filled with bone
Standard Deviation 4.59
|
14.00 percentage of space not filled with bone
Standard Deviation 12.51
|
Adverse Events
InterOss
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
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