HealthyNCT02288182
Randomized, Controlled Study to Compare Straumann® VivOss™ to Geistlich Bio-Oss® in Sinus Floor Augmentation.
A study testing Straumann VivOss and Geistlich Bio-Oss in people with Healthy, run by Institut Straumann AG at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Straumann VivOss and Geistlich Bio-Oss
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2014to Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Zentrum für Implantologie, Parodontologie und 3D- Diagnostik
Konstanz, Baden-Wurttemberg, 78462
About this study
Official title: A Randomized Controlled Clinical Trial to Investigate the Capability of Straumann® VivOss™ Compared to Geistlich Bio-Oss® in Sinus Floor Augmentation
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.
Read the 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:
- Sinus floor elevation with Straumann® VivOss™
- 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.
- Conditions
- Healthy
- Being tested
- Straumann VivOss, Geistlich Bio-Oss
- Keywords
- Sinus augmentation procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Straumann VivOssDevice
Patients will receive Straumann VivOss for sinus augmentation.
Geistlich Bio-OssDevice
Patients will receive Geistlich Bio-Oss for sinus augmentation.
| Study group | Role | What they receive |
|---|---|---|
| Straumann VivOss | Experimental | Straumann® VivOss™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. Receives: Device: Straumann VivOss |
| Geistlich Bio-Oss | Active comparator | 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. Receives: Device: Geistlich Bio-Oss |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months +/- 7 days after bone augmentation
Secondary outcomes (2)
Survival Rate of Study Implants (Based on Subjects)
Number of implants in place
Measured: 4 months +/- 1 month after implant placement
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.
Measured: 4 months +/- 1 month after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Straumann AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald Jung, PD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288182
- Sponsor's protocol ID
- CR03/13
- Status last verified
- Aug 2019
- First submitted
- 28 Oct 2014
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Buser D, Weber HP, Lang NP. Tissue integration of non-submerged implants. 1-year results of a prospective study with 100 ITI hollow-cylinder and hollow-screw implants. Clin Oral Implants Res. 1990 Dec;1(1):33-40. doi: 10.1034/j.1600-0501.1990.010105.x.
PubMed 2099210
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial to Investigate the Capability of Straumann® VivOss™ Compared to Geistlich Bio-Oss® in Sinus Floor Augmentation
- ClinicalTrials.gov ID
- NCT02288182
- Acronym / sponsor ID
- CR03/13
- Conditions
- Healthy
- Keywords
- Sinus augmentation procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Institut Straumann AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2014 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Sinus floor elevation with Straumann® VivOss™
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Straumann VivOss | Experimental | Device: Straumann VivOssStraumann® VivOss™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. |
| Geistlich Bio-Oss | Active comparator | Device: Geistlich Bio-OssThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Straumann VivOssPatients will receive Straumann VivOss for sinus augmentation. | Device | Straumann VivOss |
| Geistlich Bio-OssPatients will receive Geistlich Bio-Oss for sinus augmentation. | Device | Geistlich Bio-Oss |
Primary outcome
Ratio of Newly Formed Bone to Residual Bone Graft in Patients Treated With Straumann® VivOss™ Compared to Geistlich Bio-Oss®
Time frame: 6 months +/- 7 days after bone augmentation
Bone biopsies and histological staining
2 secondary outcomes
Survival Rate of Study Implants (Based on Subjects)
Time frame: 4 months +/- 1 month after implant placement
Success Rate of Study Implants
Time frame: 4 months +/- 1 month after implant placement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 2099210Buser D, Weber HP, Lang NP. Tissue integration of non-submerged implants. 1-year results of a prospective study with 100 ITI hollow-cylinder and hollow-screw implants. Clin Oral Implants Res. 1990 Dec;1(1):33-40. doi: 10.1034/j.1600-0501.1990.010105.x.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 3
Schizophrenia / Schizoaffective Disorder, SCHIZOPHRENIA 1 (Disorder)
Enrolling by invitation
Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods
Healthy
RecruitingObservational study
Adaptive Optics Retinal Imaging
Eye Diseases, Healthy Volunteers
RecruitingObservational study
Characterization of Diseases With Salivary Gland Involvement
Healthy Volunteer, Sjogren's Syndrome
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Jung, PD principal investigator
University of Zurich
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Straumann VivOss and Geistlich Bio-Oss in people with Healthy, run by Institut Straumann AG at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of Newly Formed Bone to Residual Bone Graft in Patients Treated With Straumann® VivOss™ Compared to Geistlich Bio-Oss® (time frame: 6 months +/- 7 days after bone augmentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02288182, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019; AzTrials last refreshed its copy on 28 Oct 2026.