Trial Outcomes & Findings for Randomized, Controlled Study to Compare Straumann® VivOss™ to Geistlich Bio-Oss® in Sinus Floor Augmentation. (NCT NCT02288182)
NCT ID: NCT02288182
Last Updated: 2019-08-28
Results Overview
Bone biopsies and histological staining
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
6 months +/- 7 days after bone augmentation
Results posted on
2019-08-28
Participant Flow
Participant milestones
| Measure |
Straumann VivOss
Subjects were randomized either to the test group receiving Straumann VivOss oder comparator group receiving Geistlich Bio-Oss. If a patient needed augmentation in both sinuses, one sinus was randomized into the test group receiving Straumann VivOss and the other (opposite) sinus should be treated with Geistlich Bio-Oss. In those bilateral patients, biopsies were taken from both sinuses.
|
Geistlich Bio-Oss
Subjects were randomized either to the test group receiving Straumann VivOss oder comparator group receiving Geistlich Bio-Oss. If a patient needed augmentation in both sinuses, one sinus was randomized into the test group receiving Straumann VivOss and the other (opposite) sinus should be treated with Geistlich Bio-Oss. In those bilateral patients, biopsies were taken from both sinuses.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
27
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Straumann VivOss
Subjects were randomized either to the test group receiving Straumann VivOss oder comparator group receiving Geistlich Bio-Oss. If a patient needed augmentation in both sinuses, one sinus was randomized into the test group receiving Straumann VivOss and the other (opposite) sinus should be treated with Geistlich Bio-Oss. In those bilateral patients, biopsies were taken from both sinuses.
|
Geistlich Bio-Oss
Subjects were randomized either to the test group receiving Straumann VivOss oder comparator group receiving Geistlich Bio-Oss. If a patient needed augmentation in both sinuses, one sinus was randomized into the test group receiving Straumann VivOss and the other (opposite) sinus should be treated with Geistlich Bio-Oss. In those bilateral patients, biopsies were taken from both sinuses.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Randomized, Controlled Study to Compare Straumann® VivOss™ to Geistlich Bio-Oss® in Sinus Floor Augmentation.
Baseline characteristics by cohort
| Measure |
Straumann VivOss
n=25 Participants
Subjects were randomized either to the test group receiving Straumann VivOss oder comparator group receiving Geistlich Bio-Oss. If a patient needed augmentation in both sinuses, one sinus was randomized into the test group receiving Straumann VivOss and the other (opposite) sinus should be treated with Geistlich Bio-Oss. In those bilateral patients, biopsies were taken from both sinuses.
|
Geistlich Bio-Oss
n=25 Participants
Subjects were randomized either to the test group receiving Straumann VivOss oder comparator group receiving Geistlich Bio-Oss. If a patient needed augmentation in both sinuses, one sinus was randomized into the test group receiving Straumann VivOss and the other (opposite) sinus should be treated with Geistlich Bio-Oss. In those bilateral patients, biopsies were taken from both sinuses.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 11.8 • n=99 Participants
|
60.3 years
STANDARD_DEVIATION 9.9 • n=107 Participants
|
59.3 years
STANDARD_DEVIATION 10.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
49 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
|
PRIMARY outcome
Timeframe: 6 months +/- 7 days after bone augmentationPopulation: The biopsies were retrieved from the central part of the dental implant osteotomy. In patients with bilateral treatment, biopsies were taken from both sinuses.
Bone biopsies and histological staining
Outcome measures
| Measure |
Straumann VivOss
n=29 biopsies
Straumann® VivOss™, is a synthetic bone graft substitute in granulated form. It consists of \> 90% TCP (Tri-Calcium-Phosphate -Ca3(PO4)2) and \< 10% Hydroxyapatite (Ca10(PO4)6 (OH)2). The granules have a size of 250-1000 μm.
Straumann VivOss: Patients will receive Straumann VivOss for sinus augmentation.
|
Geistlich Bio-Oss
n=33 biopsies
The control device is Geistlich Bio-Oss® spongiosa granules (Geistlich Pharma AG, Wolhusen, Switzerland), 0.25-1 mm in diameter. It's a natural bone mineral of bovine origin. It shall be used according to the instructions of the manufacturer.
Geistlich Bio-Oss: Patients will receive Geistlich Bio-Oss for sinus augmentation.
|
|---|---|---|
|
Ratio of Newly Formed Bone to Residual Bone Graft in Patients Treated With Straumann® VivOss™ Compared to Geistlich Bio-Oss®
|
1.37 ratio
Interval 1.0 to 2.22
|
0.69 ratio
Interval 0.58 to 1.05
|
SECONDARY outcome
Timeframe: 4 months +/- 1 month after implant placementPopulation: ITT Data Set
Number of implants in place
Outcome measures
| Measure |
Straumann VivOss
n=25 Participants
Straumann® VivOss™, is a synthetic bone graft substitute in granulated form. It consists of \> 90% TCP (Tri-Calcium-Phosphate -Ca3(PO4)2) and \< 10% Hydroxyapatite (Ca10(PO4)6 (OH)2). The granules have a size of 250-1000 μm.
Straumann VivOss: Patients will receive Straumann VivOss for sinus augmentation.
|
Geistlich Bio-Oss
n=25 Participants
The control device is Geistlich Bio-Oss® spongiosa granules (Geistlich Pharma AG, Wolhusen, Switzerland), 0.25-1 mm in diameter. It's a natural bone mineral of bovine origin. It shall be used according to the instructions of the manufacturer.
Geistlich Bio-Oss: Patients will receive Geistlich Bio-Oss for sinus augmentation.
|
|---|---|---|
|
Survival Rate of Study Implants (Based on Subjects)
|
24 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 4 months +/- 1 month after implant placementPopulation: ITT Data Set
Buser success criteria: * Absence of persisting subjective discomfort such as pain, foreign body perception and or dysaesthesia (painful sensation) * Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics) * Absence of implant mobility on manual palpation * Absence of any continuous peri-implant radiolucency.
Outcome measures
| Measure |
Straumann VivOss
n=25 Participants
Straumann® VivOss™, is a synthetic bone graft substitute in granulated form. It consists of \> 90% TCP (Tri-Calcium-Phosphate -Ca3(PO4)2) and \< 10% Hydroxyapatite (Ca10(PO4)6 (OH)2). The granules have a size of 250-1000 μm.
Straumann VivOss: Patients will receive Straumann VivOss for sinus augmentation.
|
Geistlich Bio-Oss
n=25 Participants
The control device is Geistlich Bio-Oss® spongiosa granules (Geistlich Pharma AG, Wolhusen, Switzerland), 0.25-1 mm in diameter. It's a natural bone mineral of bovine origin. It shall be used according to the instructions of the manufacturer.
Geistlich Bio-Oss: Patients will receive Geistlich Bio-Oss for sinus augmentation.
|
|---|---|---|
|
Success Rate of Study Implants
|
25 Participants
|
25 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months +/- 7 days after bone augmentationPopulation: ITT Data Set
This measure describes the basic bone situation of the patients at baseline, i.e. the bone thickness as a unit of area before the application of bone substitute material.
Outcome measures
| Measure |
Straumann VivOss
n=25 Participants
Straumann® VivOss™, is a synthetic bone graft substitute in granulated form. It consists of \> 90% TCP (Tri-Calcium-Phosphate -Ca3(PO4)2) and \< 10% Hydroxyapatite (Ca10(PO4)6 (OH)2). The granules have a size of 250-1000 μm.
Straumann VivOss: Patients will receive Straumann VivOss for sinus augmentation.
|
Geistlich Bio-Oss
n=25 Participants
The control device is Geistlich Bio-Oss® spongiosa granules (Geistlich Pharma AG, Wolhusen, Switzerland), 0.25-1 mm in diameter. It's a natural bone mineral of bovine origin. It shall be used according to the instructions of the manufacturer.
Geistlich Bio-Oss: Patients will receive Geistlich Bio-Oss for sinus augmentation.
|
|---|---|---|
|
Basic Bone Situation
|
1.50 mm^2
Standard Deviation 0.42
|
1.27 mm^2
Standard Deviation 0.43
|
Adverse Events
Straumann VivOss
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Geistlich Bio-Oss
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Straumann VivOss
n=25 participants at risk
Subjects were randomized either to the test group receiving Straumann VivOss oder comparator group receiving Geistlich Bio-Oss. If a patient needed augmentation in both sinuses, one sinus was randomized into the test group receiving Straumann VivOss and the other (opposite) sinus should be treated with Geistlich Bio-Oss. In those bilateral patients, biopsies were taken from both sinuses.
|
Geistlich Bio-Oss
n=27 participants at risk
Subjects were randomized either to the test group receiving Straumann VivOss oder comparator group receiving Geistlich Bio-Oss. If a patient needed augmentation in both sinuses, one sinus was randomized into the test group receiving Straumann VivOss and the other (opposite) sinus should be treated with Geistlich Bio-Oss. In those bilateral patients, biopsies were taken from both sinuses.
|
|---|---|---|
|
Renal and urinary disorders
urinary tract infection (leading to hospitalization)
|
0.00%
0/25 • Overall study period (10 months per patient)
|
3.7%
1/27 • Number of events 1 • Overall study period (10 months per patient)
|
Other adverse events
| Measure |
Straumann VivOss
n=25 participants at risk
Subjects were randomized either to the test group receiving Straumann VivOss oder comparator group receiving Geistlich Bio-Oss. If a patient needed augmentation in both sinuses, one sinus was randomized into the test group receiving Straumann VivOss and the other (opposite) sinus should be treated with Geistlich Bio-Oss. In those bilateral patients, biopsies were taken from both sinuses.
|
Geistlich Bio-Oss
n=27 participants at risk
Subjects were randomized either to the test group receiving Straumann VivOss oder comparator group receiving Geistlich Bio-Oss. If a patient needed augmentation in both sinuses, one sinus was randomized into the test group receiving Straumann VivOss and the other (opposite) sinus should be treated with Geistlich Bio-Oss. In those bilateral patients, biopsies were taken from both sinuses.
|
|---|---|---|
|
Product Issues
implant loss
|
0.00%
0/25 • Overall study period (10 months per patient)
|
11.1%
3/27 • Number of events 4 • Overall study period (10 months per patient)
|
|
General disorders
swelling
|
8.0%
2/25 • Number of events 2 • Overall study period (10 months per patient)
|
3.7%
1/27 • Number of events 1 • Overall study period (10 months per patient)
|
|
General disorders
pain
|
8.0%
2/25 • Number of events 2 • Overall study period (10 months per patient)
|
0.00%
0/27 • Overall study period (10 months per patient)
|
|
General disorders
injury
|
4.0%
1/25 • Number of events 1 • Overall study period (10 months per patient)
|
0.00%
0/27 • Overall study period (10 months per patient)
|
|
General disorders
compromised wound healing
|
4.0%
1/25 • Number of events 1 • Overall study period (10 months per patient)
|
0.00%
0/27 • Overall study period (10 months per patient)
|
|
General disorders
dehiscence
|
0.00%
0/25 • Overall study period (10 months per patient)
|
3.7%
1/27 • Number of events 1 • Overall study period (10 months per patient)
|
|
Product Issues
explantation
|
4.0%
1/25 • Number of events 1 • Overall study period (10 months per patient)
|
0.00%
0/27 • Overall study period (10 months per patient)
|
|
Infections and infestations
infection
|
0.00%
0/25 • Overall study period (10 months per patient)
|
3.7%
1/27 • Number of events 1 • Overall study period (10 months per patient)
|
Additional Information
Dr. Manfred Klasser
gwd consult · contract research
Phone: +49 (6108) 8256520
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place