Healthy
Conditions
Keywords
Sinus augmentation procedure
Brief summary
A randomized controlled clinical trial to investigate the capability of Straumann® VivOss™ compared to Geistlich Bio-Oss in sinus floor augmentation to demonstrate superiority of Straumann® VivOss™ compared to Geistlich Bio-Oss in regards to the ratio of newly formed bone to residual bone substitute.
Detailed description
This is a prospective, randomized, controlled study. The total study duration for each patient should be 9-14 months (from screening to last visit). Enrolled subjects are randomized to one of the following groups: 1. Sinus floor elevation with Straumann® VivOss™ 2. Sinus floor elevation with Geistlich Bio-Oss® In total 6 visits per patient are scheduled in this study. The histological evaluation of the ratio of newly formed bone to residual bone graft, survival and success rate of study implants and adverse events (AEs) will be assessed. The study devices Straumann® VivOss™ and Geistlich Bio-Oss are CE-(Conformité Européenne, meaning European Conformity) marked products. Two centers, one in Germany and one in Switzerland will participate.
Interventions
DEVICEStraumann VivOss
Patients will receive Straumann VivOss for sinus augmentation.
DEVICEGeistlich Bio-Oss
Patients will receive Geistlich Bio-Oss for sinus augmentation.
Sponsors
Institut Straumann AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject must have voluntarily signed the informed consent before any study related action * Males and females with at least 18 years of age (including 18 years) * Subject needs augmentation procedure in the sinus to prepare for implant placement. * Subject must have a residual bone height of 2 to 4 mm. * Adequate oral hygiene ((Full mouth plaque index (O'Leary, et al. 1972 ) \<25%) at baseline * Adequate control of inflammation ((full mouth bleeding on probing (Ainamo and Bay 1975)) ≤25% at baseline
Exclusion criteria
* Systemic disease that would interfere with bone or wound healing and dental implant therapy (e.g. uncontrolled diabetes) * Systemic disease that would interfere with bone or wound healing and dental implant therapy (e.g. uncontrolled diabetes) * Any contraindications for general bone grafting and oral surgical procedures * Any anomalies of the sinus that could interfere with planned procedures * History of local irradiation therapy * Local inflammation, including untreated periodontitis * Medical conditions requiring chronic high dose steroid therapy * Treatment with an investigational drug or device within a 30 day period immediately prior to surgery at visit 2, or expected participation in any other investigational drug or device study during the conduct of this trial. * Antibiotic treatment or anti-inflammatory treatment within 4 weeks prior to surgery * History of alcoholism or drug abuse * Immunocompromised subjects * Subjects who smoke \>10 cigarettes per day or tobacco equivalents or chew tobacco * Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability * Physical or mental disabilities that would interfere with the ability to perform adequate oral hygiene * Current pregnancy (pregnancy test) and breastfeeding women Secondary exclusion criterium: Defects of the Schneider Membrane
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of Newly Formed Bone to Residual Bone Graft in Patients Treated With Straumann® VivOss™ Compared to Geistlich Bio-Oss® | 6 months +/- 7 days after bone augmentation | Bone biopsies and histological staining |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival Rate of Study Implants (Based on Subjects) | 4 months +/- 1 month after implant placement | Number of implants in place |
| Success Rate of Study Implants | 4 months +/- 1 month after implant placement | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Basic Bone Situation | 6 months +/- 7 days after bone augmentation | 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. |
Countries
Germany, Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Straumann VivOss | Geistlich Bio-Oss | Total |
|---|---|---|---|
| Age, Continuous | 58.4 years STANDARD_DEVIATION 11.8 | 60.3 years STANDARD_DEVIATION 9.9 | 59.3 years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 25 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 18 Participants | 15 Participants | 33 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 27 |
| other Total, other adverse events | 7 / 25 | 6 / 27 |
| serious Total, serious adverse events | 0 / 25 | 1 / 27 |
Outcome results
Primary
Ratio of Newly Formed Bone to Residual Bone Graft in Patients Treated With Straumann® VivOss™ Compared to Geistlich Bio-Oss®
Bone biopsies and histological staining
Time frame: 6 months +/- 7 days after bone augmentation
Population: The biopsies were retrieved from the central part of the dental implant osteotomy. In patients with bilateral treatment, biopsies were taken from both sinuses.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Straumann VivOss | Ratio of Newly Formed Bone to Residual Bone Graft in Patients Treated With Straumann® VivOss™ Compared to Geistlich Bio-Oss® | 1.37 ratio |
| Geistlich Bio-Oss | Ratio of Newly Formed Bone to Residual Bone Graft in Patients Treated With Straumann® VivOss™ Compared to Geistlich Bio-Oss® | 0.69 ratio |
Comparison: Student's t-test comparing the group means was planned and performed (successfully). However, due to some outliers, the central tendencies have been reported as medians (instead of arithmetic means). Therefore an additional non-parameteric test (Mann-Whitney U-test) was performed.p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
Success Rate of Study Implants
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.
Time frame: 4 months +/- 1 month after implant placement
Population: ITT Data Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Straumann VivOss | Success Rate of Study Implants | 25 Participants |
| Geistlich Bio-Oss | Success Rate of Study Implants | 25 Participants |
Secondary
Survival Rate of Study Implants (Based on Subjects)
Number of implants in place
Time frame: 4 months +/- 1 month after implant placement
Population: ITT Data Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Straumann VivOss | Survival Rate of Study Implants (Based on Subjects) | 24 Participants |
| Geistlich Bio-Oss | Survival Rate of Study Implants (Based on Subjects) | 22 Participants |
Other Pre-specified
Basic Bone Situation
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.
Time frame: 6 months +/- 7 days after bone augmentation
Population: ITT Data Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Straumann VivOss | Basic Bone Situation | 1.50 mm^2 | Standard Deviation 0.42 |
| Geistlich Bio-Oss | Basic Bone Situation | 1.27 mm^2 | Standard Deviation 0.43 |