Jaw, Edentulous, PartiallyNCT00900822
Straumann Bone Ceramic Versus BioOss in Sinus Elevation
A study testing Straumann Bone Ceramic and BioOss in people with Jaw, Edentulous, Partially and Alveolar Bone Loss, run by Institut Straumann AG at 1 site in Sweden.
Trial summary
Straumann Bone Ceramic (SBC) and BioOss will be used as bone grafting materials when there is a need for bone augmentation in the posterior upper jaw. 9 months later the bone formation is evaluated. The patients are followed for 3 years.The study hypothesis is that the SBC is not worse than BioOss. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Jaw, Edentulous, Partially, Alveolar Bone Loss
- What is being tested?
- Straumann Bone Ceramic and BioOss
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2005to Dec 2008
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, 18 years to 80 years of age
- The patients are at least partly edentulous in the both maxillary regions corresponding to the sinuses.
- A dental implant procedure is foreseen in both maxilla regions corresponding to maxillary sinuses.
- Patients must be expected to present a bilateral bone defect in the sinus area, which both need a sinus floor augmentation to place one or more dental implants each.
- Residual alveolar crest height of the lateral-posterior segments of the edentulous maxilla below the floor of each of the maxillary sinuses shall be
- less than 5 mm and at least 2 mm, as measured by Scanora - tomography Scans in the deepest floor of the sinus
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- residual alveolar crest width should be at least in average more than 4mm as measured by Scanora - tomography scans
- Patients must be committed to the study and must sign informed consent.
- Oral hygiene Index less than 25%
Who cannot join
- Any systemic medical condition that could interfere with the surgical procedure or planned treatment
- Current pregnancy at the time of recruitment
- Physical handicaps that would interfere with the ability to perform adequate oral hygiene
- Alcoholism or chronically drug abuse causing systemic compromize
- Patients who smoke more than 10 cigarettes per day
- Medication which interferes with bone formation
Show all 15Show fewer
- 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
- 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
- Previous GBR (bone graft) or dental implant treatment in the posterior segments of the upper maxilla (foreseen implant site)
- Patients presenting clinical and radiological signs and symptoms of maxillary sinus disease
- Existing teeth in the residual dentition with untreated endodontic problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Controlled Clinical Study to Compare Bone Formation Around Micro-implants in the Maxilla After Sinus Floor Augmentation With Straumann Bone Ceramic or Bio-Oss in a Split Mouth Design
Straumann Bone Ceramic (SBC) and BioOss will be used as bone grafting materials when there is a need for bone augmentation in the posterior upper jaw. 9 months later the bone formation is evaluated. The patients are followed for 3 years.The study hypothesis is that the SBC is not worse than BioOss.
Read the detailed description
Straumann Bone Ceramic (SBC) and BioOss will be used as bone grafting materials when there is a need for bone augmentation in the posterior upper jaw. The bone grafting materials will be placed into the sinus cavity,(a routine procedure), one material randomly at each side and a micro-implant will be inserted simultaneously. 9 months later the micro-implant is removed and a regular Straumann SLActive implant is inserted. The micro-implant is evaluated histologically. The site is evaluated every 12 months for 3 years in regards to clinical measurements. The study hypothesis is that the SBC is not worse than BioOss.
Study design: Prospective, randomized, open, controlled, single center, split mouth
Study population: 11 male and female patients at an age of between 18 and 80 years, affected by edentulism of both lateral-posterior maxilla and presenting two pneumatized maxillary sinuses and necessitating rehabilitation with implant-supported prostheses will be recruited in the study and treated by means of maxillary sinus floor augmentation and delayed implant placement.
- Conditions
- Jaw, Edentulous, Partially, Alveolar Bone Loss
- Being tested
- Straumann Bone Ceramic, BioOss
- Keywords
- bone grafting, sinus elevation, sinus augmentation
- Medical subject headings
- Jaw, Edentulous, Partially, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Straumann Bone CeramicDevice
Granules applied once during surgery
BioOssDevice
Granules that are applied once during surgery
| Study group | Role | What they receive |
|---|---|---|
| Straumann Bone Ceramic | Experimental | StraumannBone Ceramic is used as bone grafting material in sinus augmentation procedures Receives: Device: Straumann Bone Ceramic |
| BioOss | Active comparator | BioOss is used as a bone grafting material in sinus augmentation procedure Receives: Device: BioOss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histologically Measured Bone to Implant Contact (BIC)
Results from morphometric measurements of percentage of new bone in contact with the total surface of the titanium implant, area of new bone and bone graft particles in contact with bone
Measured: 9 months after implant placement
Secondary outcomes (2)
Implant Survival Rate
The percentage of implants remaining in the jaw.
Measured: 12 months after loading the implant
Implant Success Rate
Implant success is defined as the absence of any continuous peri-implant radiolucency based on radiographic findings, absence of implant mobility, absence of a recurrent per-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more 3-month follow-up visits after treatment with systemic antibiotics), and bone level changes around the implant less than 1 mm during the first year of loading and less than 0.2 mm per year thereafter.
Measured: 12 months after loading the implant
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 startNov 2005
- Primary completionJun 2007
- Study completionDec 2008
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 (2)Papers the sponsor has linked to this study.
- Other trials for Jaw, Edentulous, PartiallyStudies 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Straumann AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mats Hallman, DDS, PhD, Principal investigator, Clinic for oral maxillofacial surgery, Gävle hospital, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900822
- Sponsor's protocol ID
- CR 02/05
- Status last verified
- Mar 2016
- First submitted
- 11 May 2009
- Last updated
- 31 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lindgren C, Mordenfeld A, Hallman M. A prospective 1-year clinical and radiographic study of implants placed after maxillary sinus floor augmentation with synthetic biphasic calcium phosphate or deproteinized bovine bone. Clin Implant Dent Relat Res. 2012 Mar;14(1):41-50. doi: 10.1111/j.1708-8208.2010.00224.x. Epub 2010 May 11.
PubMed 20491816Lindgren C, Sennerby L, Mordenfeld A, Hallman M. Clinical histology of microimplants placed in two different biomaterials. Int J Oral Maxillofac Implants. 2009 Nov-Dec;24(6):1093-100.
PubMed 20162114
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Clinical Study to Compare Bone Formation Around Micro-implants in the Maxilla After Sinus Floor Augmentation With Straumann Bone Ceramic or Bio-Oss in a Split Mouth Design
- ClinicalTrials.gov ID
- NCT00900822
- Acronym / sponsor ID
- CR 02/05
- Conditions
- Jaw, Edentulous, Partially, Alveolar Bone Loss
- Keywords
- bone grafting, sinus elevation, sinus augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Institut Straumann AGIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 13 May 2009 (estimated)
- Results
- Posted 31 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Straumann Bone Ceramic (SBC) and BioOss will be used as bone grafting materials when there is a need for bone augmentation in the posterior upper jaw. 9 months later the bone formation is evaluated. The patients are followed for 3 years.The study hypothesis is that the SBC is not worse than BioOss.
Detailed description
Straumann Bone Ceramic (SBC) and BioOss will be used as bone grafting materials when there is a need for bone augmentation in the posterior upper jaw. The bone grafting materials will be placed into the sinus cavity,(a routine procedure), one material randomly at each side and a micro-implant will be inserted simultaneously. 9 months later the micro-implant is removed and a regular Straumann SLActive implant is inserted. The micro-implant is evaluated histologically. The site is evaluated every 12 months for 3 years in regards to clinical measurements. The study hypothesis is that the SBC is not worse than BioOss.
Study design: Prospective, randomized, open, controlled, single center, split mouth
Study population: 11 male and female patients at an age of between 18 and 80 years, affected by edentulism of both lateral-posterior maxilla and presenting two pneumatized maxillary sinuses and necessitating rehabilitation with implant-supported prostheses will be recruited in the study and treated by means of maxillary sinus floor augmentation and delayed implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Straumann Bone Ceramic | Experimental | Device: Straumann Bone CeramicStraumannBone Ceramic is used as bone grafting material in sinus augmentation procedures |
| BioOss | Active comparator | Device: BioOssBioOss is used as a bone grafting material in sinus augmentation procedure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females, 18 years to 80 years of age
- The patients are at least partly edentulous in the both maxillary regions corresponding to the sinuses.
- A dental implant procedure is foreseen in both maxilla regions corresponding to maxillary sinuses.
- Patients must be expected to present a bilateral bone defect in the sinus area, which both need a sinus floor augmentation to place one or more dental implants each.
- Residual alveolar crest height of the lateral-posterior segments of the edentulous maxilla below the floor of each of the maxillary sinuses shall be
Key exclusion criteria (15 listed)
- Any systemic medical condition that could interfere with the surgical procedure or planned treatment
- Current pregnancy at the time of recruitment
- Physical handicaps that would interfere with the ability to perform adequate oral hygiene
- Alcoholism or chronically drug abuse causing systemic compromize
- Patients who smoke more than 10 cigarettes per day
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 Bone CeramicGranules applied once during surgery | Device | Straumann Bone Ceramic |
| BioOssGranules that are applied once during surgery | Device | BioOss |
Primary outcome
Histologically Measured Bone to Implant Contact (BIC)
Time frame: 9 months after implant placement
Results from morphometric measurements of percentage of new bone in contact with the total surface of the titanium implant, area of new bone and bone graft particles in contact with bone
2 secondary outcomes
Implant Survival Rate
Time frame: 12 months after loading the implant
Implant Success Rate
Time frame: 12 months after loading the implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20491816Lindgren C, Mordenfeld A, Hallman M. A prospective 1-year clinical and radiographic study of implants placed after maxillary sinus floor augmentation with synthetic biphasic calcium phosphate or deproteinized bovine bone. Clin Implant Dent Relat Res. 2012 Mar;14(1):41-50. doi: 10.1111/j.1708-8208.2010.00224.x. Epub 2010 May 11.
- Results publication: PubMed 20162114Lindgren C, Sennerby L, Mordenfeld A, Hallman M. Clinical histology of microimplants placed in two different biomaterials. Int J Oral Maxillofac Implants. 2009 Nov-Dec;24(6):1093-100.
- 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.
Mats Hallman, DDS, PhD principal investigator
Clinic for oral maxillofacial surgery, Gävle hospital, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Straumann Bone Ceramic and BioOss in people with Jaw, Edentulous, Partially and Alveolar Bone Loss, run by Institut Straumann AG at 1 site in Sweden.
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 9 inclusion and 15 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 31 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 1 site in Sweden. 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 31 Aug 2012). 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?
Histologically Measured Bone to Implant Contact (BIC) (time frame: 9 months after implant placement). 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 NCT00900822, which also lists 2 linked publications.
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 31 Mar 2016; AzTrials last refreshed its copy on 26 Oct 2026.