Teeth LossNCT00901121
Maxillary Sinus Elevation With Bio-Oss or Straumann BoneCeramic
A study testing Straumann BoneCeramic and Bio-Oss in people with Teeth Loss and Bone Loss, run by Institut Straumann AG at 8 sites in Italy.
Trial summary
The purpose of the study was to test a clinically relevant non-inferiority of Straumann BoneCeramic treatment compared to Bio-Oss treatment 180 to 240 days after sinus grafting procedure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Teeth Loss, Bone Loss
- What is being tested?
- Straumann BoneCeramic and Bio-Oss
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 8 sitesItaly
- Study dates
- Jul 2005to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females were at least 18 years of age and not more than 70 years old
- A dental implant procedure was foreseen in the maxilla region corresponding to maxillary sinus
- Patients presented a bone defect in the sinus area, which needed a sinus floor elevation to place one or more dental implants
- The patients were unilaterally or bilaterally edentulous in the maxillary region corresponding to the sinuses
- Residual alveolar crest height of the lateral-posterior segments of the edentulous maxilla below the floor of the maxillary sinus was less than 8 mm and at least 3 mm, measured by CT scans. Furthermore, residual alveolar crest width should be at least in average 6 mm measured by the CT scans
- Patients were committed to the study
- Patients were healthy at time of surgery
Who cannot join
- Medical conditions requiring prolonged use of steroids
- Standard blood test performed by the medical practitioner of the patient showing: leukocyte dysfunction and deficiencies
- Haemophilia, bleeding disorders or cumarin therapy
- History of neoplastic disease requiring the use of chemotherapy
- History of radiation therapy to the head and neck
- Patients with history of renal failure or chronic renal diseases
Show all 32Show fewer
- Patients affected by chronic liver diseases
- Patients with severe or uncontrolled metabolic bone disorders
- Uncontrolled endocrine disorders (including diabetes)
- Current pregnancy at the time of recruitment
- Physical handicaps that would interfere with the ability to perform adequate oral hygiene
- Use of any investigational drug or device within the 90 days period immediately prior to implant surgery on study day 0
- Alcoholism or chronically drug abuse causing systemic compromisation
- Immunocompromised patients including patients infected with HIV
- Patients who smoke more than 10 cigarettes per day or cigar equivalents, or who chew tobacco
- Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability
- Local exclusion criteria
- Local inflammation, including untreated periodontitis to residual dentition
- Mucosal diseases such as erosive lichen planus
- History of local radiation therapy
- Presence of oral lesions (such as ulceration, malignancy)
- Severe bruxing or clenching habits
- Persistent intraoral infection
- Patients with inadequate oral hygiene or unmotivated for adequate home care
- Unhealed extraction sites in the upper premolar or molar area
- Last tooth extraction performed less than 3 months before surgery 1
- Previous GBR (guided bone regeneration) or dental implant treatment in the lateral-posterior segments of the upper maxilla (foreseen implant site)
- Patients presenting clinical and radiological signs and symptoms of maxillary sinus disease
- Patients presenting with residual alveolar crest height of the lateral-posterior segments of the edentulous maxilla below the floor of the maxillary sinus less than 3 mm and residual alveolar crest width less than 6 mm (measured by the CT scans)
- The reduction in residual bone height was determined by sinus pneumatization and not by vertical resorption of the residual alveolar crest with increased interarch distance. Patients with increased interarch distance were excluded from the study
- Existing teeth in the residual dentition with untreated endodontic or cariologic problems
- Horizontal or vertical augmentation to correct the vertical inter-arch distance or to correct horizontal defects
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
Private Practice
Milan, 20124
University of Milan
Milan, 20142
Private Practice
Naples, 80121
Private Practice
Naples, 80429
Private Practice
Pavia, 27100
Private Practice
Rome, 00145
Private Practice
Rome, 00151
Eastman Dental Hospital ASL RMA Roma
Rome, 00197
About this study
Official title: Maxillary Sinus Grafting With Bio-Oss or Straumann Bone Ceramic Followed by Delayed Placement of Straumann Dental Implants: A Comparative Histomorphometric and Clinical Study
The purpose of the study was to test a clinically relevant non-inferiority of Straumann BoneCeramic treatment compared to Bio-Oss treatment 180 to 240 days after sinus grafting procedure.
Read the detailed description
This is a prospective, controlled, randomised, multicenter study. The total study duration for each patient should be three years.
In total 13 visits per patient are scheduled in this study.
The study device Straumann Bone Ceramic is CE-marked.
Height centers in Italy will participate.
- Conditions
- Teeth Loss, Bone Loss
- Being tested
- Straumann BoneCeramic, Bio-Oss
- Keywords
- maxillary sinus lift, Histomorphometric evaluation, bone graft, bone augmentation
- Medical subject headings
- Anodontia, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Straumann BoneCeramicDevice
Straumann BoneCeramic (500-1000 microns, 0.5g)
Bio-OssDevice
Bio-Oss spongiosa granules, size of particle 0.25-1 mm
| Study group | Role | What they receive |
|---|---|---|
| BoneCeramic | Experimental | Straumann BoneCeramic is a fully synthetic bone graft substitute of medical grade purity in particulate form composed of biphasic calcium phosphate - a mixture of 60% hydroxylapatite and of 40% of the beta form of tricalcium phosphate (beta-TCP). Receives: Device: Straumann BoneCeramic |
| Bio-Oss | Active comparator | Bio-Oss spongiosa granules, size of particle 0.25-1 mm Receives: Device: Bio-Oss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological evaluation of the ratio between new bone and residual graft material at the implant site 180 to 240 days after graft-placement.
Measured: 180 to 240 days
Secondary outcomes (3)
Histomorphometric evaluation of the amount of new bone, soft tissue and remaining graft in the treatment, control and in a 1mm compartment 1mm close to the autogenous bone and the amount of new bone on contact with the graft.
Measured: 180 to 240 days
Evaluation of the survival and success rate of Straumann dental implants placed in the grafted areas
Measured: 3 years
Clinical evaluation of peri implant soft tissue
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startJul 2005
- Primary completionApr 2007
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Teeth LossStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Straumann AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matteo Chiapasco, Prof, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901121
- Sponsor's protocol ID
- CR 09/04
- Status last verified
- Mar 2016
- First submitted
- 11 May 2009
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cordaro L, Bosshardt DD, Palattella P, Rao W, Serino G, Chiapasco M. Maxillary sinus grafting with Bio-Oss or Straumann Bone Ceramic: histomorphometric results from a randomized controlled multicenter clinical trial. Clin Oral Implants Res. 2008 Aug;19(8):796-803. doi: 10.1111/j.1600-0501.2008.01565.x.
PubMed 18705811
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maxillary Sinus Grafting With Bio-Oss or Straumann Bone Ceramic Followed by Delayed Placement of Straumann Dental Implants: A Comparative Histomorphometric and Clinical Study
- ClinicalTrials.gov ID
- NCT00901121
- Acronym / sponsor ID
- CR 09/04
- Conditions
- Teeth Loss, Bone Loss
- Keywords
- maxillary sinus lift, Histomorphometric evaluation, bone graft, bone augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Institut Straumann AGIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 13 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study was to test a clinically relevant non-inferiority of Straumann BoneCeramic treatment compared to Bio-Oss treatment 180 to 240 days after sinus grafting procedure.
Detailed description
This is a prospective, controlled, randomised, multicenter study. The total study duration for each patient should be three years.
In total 13 visits per patient are scheduled in this study.
The study device Straumann Bone Ceramic is CE-marked.
Height centers in Italy will participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BoneCeramic | Experimental | Device: Straumann BoneCeramicStraumann BoneCeramic is a fully synthetic bone graft substitute of medical grade purity in particulate form composed of biphasic calcium phosphate - a mixture of 60% hydroxylapatite and of 40% of the beta form of tricalcium phosphate (beta-TCP). |
| Bio-Oss | Active comparator | Device: Bio-OssBio-Oss spongiosa granules, size of particle 0.25-1 mm |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females were at least 18 years of age and not more than 70 years old
- A dental implant procedure was foreseen in the maxilla region corresponding to maxillary sinus
- Patients presented a bone defect in the sinus area, which needed a sinus floor elevation to place one or more dental implants
- The patients were unilaterally or bilaterally edentulous in the maxillary region corresponding to the sinuses
- Residual alveolar crest height of the lateral-posterior segments of the edentulous maxilla below the floor of the maxillary sinus was less than 8 mm and at least 3 mm, measured by CT scans. Furthermore, residual alveolar crest width should be at least in average 6 mm measured by the CT scans
Key exclusion criteria (32 listed)
- Medical conditions requiring prolonged use of steroids
- Standard blood test performed by the medical practitioner of the patient showing: leukocyte dysfunction and deficiencies
- Haemophilia, bleeding disorders or cumarin therapy
- History of neoplastic disease requiring the use of chemotherapy
- History of radiation therapy to the head and neck
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 BoneCeramicStraumann BoneCeramic (500-1000 microns, 0.5g) | Device | BoneCeramic |
| Bio-OssBio-Oss spongiosa granules, size of particle 0.25-1 mm | Device | Bio-Oss |
Primary outcome
Histological evaluation of the ratio between new bone and residual graft material at the implant site 180 to 240 days after graft-placement.
Time frame: 180 to 240 days
3 secondary outcomes
Histomorphometric evaluation of the amount of new bone, soft tissue and remaining graft in the treatment, control and in a 1mm compartment 1mm close to the autogenous bone and the amount of new bone on contact with the graft.
Time frame: 180 to 240 days
Evaluation of the survival and success rate of Straumann dental implants placed in the grafted areas
Time frame: 3 years
Clinical evaluation of peri implant soft tissue
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
- Results publication: PubMed 18705811Cordaro L, Bosshardt DD, Palattella P, Rao W, Serino G, Chiapasco M. Maxillary sinus grafting with Bio-Oss or Straumann Bone Ceramic: histomorphometric results from a randomized controlled multicenter clinical trial. Clin Oral Implants Res. 2008 Aug;19(8):796-803. doi: 10.1111/j.1600-0501.2008.01565.x.
- Individual participant dataSharing planned: No
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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.
Matteo Chiapasco, Prof principal investigator
University of Milan
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Straumann BoneCeramic and Bio-Oss in people with Teeth Loss and Bone Loss, run by Institut Straumann AG at 8 sites in Italy.
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 7 inclusion and 32 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 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Histological evaluation of the ratio between new bone and residual graft material at the implant site 180 to 240 days after graft-placement. (time frame: 180 to 240 days). 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 NCT00901121, 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 3 Mar 2016.