Trial Outcomes & Findings for Bone Material Comparison in Maxillary Sinus Augmentation (NCT NCT04433117)
NCT ID: NCT04433117
Last Updated: 2024-03-21
Results Overview
Bone density will be measured by limited view CBCT radiography pre- and post-operatively.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
5 months
Results posted on
2024-03-21
Participant Flow
24 participants were consented for the study but 2 did not meet eligibility criteria and did not receive an intervention
Participant milestones
| Measure |
Control Group
Control group in this study will comprise of 10 subjects and will receive Bio-Oss xenograft bone material.
Bio-Oss: Xenograft Bone substitute. Bone from animals.
|
Test Group
The test group in this study will comprise of 10 subjects and will receive Shefabone synthetic bone substitute.
Shefabone: Silica-calcium phosphate composite.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
7
|
|
Overall Study
COMPLETED
|
14
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Control Group
Control group in this study will comprise of 10 subjects and will receive Bio-Oss xenograft bone material.
Bio-Oss: Xenograft Bone substitute. Bone from animals.
|
Test Group
The test group in this study will comprise of 10 subjects and will receive Shefabone synthetic bone substitute.
Shefabone: Silica-calcium phosphate composite.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Bone Material Comparison in Maxillary Sinus Augmentation
Baseline characteristics by cohort
| Measure |
Control Group
n=15 Participants
Control group in this study will comprise of 10 subjects and will receive Bio-Oss xenograft bone material.
Bio-Oss: Xenograft Bone substitute. Bone from animals.
|
Test Group
n=7 Participants
The test group in this study will comprise of 10 subjects and will receive Shefabone synthetic bone substitute.
Shefabone: Silica-calcium phosphate composite.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 12.4 • n=93 Participants
|
63.4 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
62.9 years
STANDARD_DEVIATION 11.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=93 Participants
|
7 participants
n=4 Participants
|
22 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 5 monthsPopulation: Data was incomplete for 4 subjects due to poor diagnostic quality or missed appointment
Bone density will be measured by limited view CBCT radiography pre- and post-operatively.
Outcome measures
| Measure |
Control Group
n=10 Participants
Control group in this study will comprise of 10 subjects and will receive Bio-Oss xenograft bone material.
Bio-Oss: Xenograft Bone substitute. Bone from animals.
|
Test Group
n=7 Participants
The test group in this study will comprise of 10 subjects and will receive Shefabone synthetic bone substitute.
Shefabone: Silica-calcium phosphate composite.
|
|---|---|---|
|
Bone Density - Limited View CBCT (Cone-beam Computed Tomography) Measurements
|
14.4 percentage of bone height shrinkage
Standard Deviation 3.9
|
1.5 percentage of bone height shrinkage
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: 5.5 monthsPopulation: Data was incomplete for 4 subjects due to poor diagnostic quality or missed appointment
Bone quality will be measured using histomorphometric analysis.
Outcome measures
| Measure |
Control Group
n=10 Participants
Control group in this study will comprise of 10 subjects and will receive Bio-Oss xenograft bone material.
Bio-Oss: Xenograft Bone substitute. Bone from animals.
|
Test Group
n=7 Participants
The test group in this study will comprise of 10 subjects and will receive Shefabone synthetic bone substitute.
Shefabone: Silica-calcium phosphate composite.
|
|---|---|---|
|
Bone Quality
|
60 percentage of mineralized bone formation
Standard Deviation 0
|
100 percentage of mineralized bone formation
Standard Deviation 0
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Test Group
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