Sinus Implant ReconstructionPhase 2/3NCT00163605
Performance and Safety of Bone Substitute MBCP-FS in Maxillary Sinus Lift Procedures
A Phase 2/3 study testing Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS) in people with Sinus Implant Reconstruction, run by Baxter Healthcare Corporation at 3 sites in Germany.
Trial summary
The purpose of this study is to evaluate the performance and to monitor the safety of the bone substitute Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS) in Sinus Lift Procedures . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sinus Implant Reconstruction
- What is being tested?
- Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS)
- Type of treatment
- Medical device
- How many people
- 86 participants
- Where
- 3 sitesGermany
- Study dates
- Sep 2004to Nov 2007
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent obtained from the subject prior to participation in the study
- At least 18 years of age
- Partially or totally edentulous with an atrophic posterior maxilla requiring unilateral or bilateral sinus lift before dental implant placement
- In case of bilateral sinus lifts, both sides are operated on the same day.
- Subjects with remaining minimal maxillary bone height between 2 mm and 5 mm at the site with minimal height in the area where implants are planned, and a remaining maxillary bone thickness >= 5 mm in the area where implants are planned
Who cannot join
- Previous or coeval major surgical intervention in the targeted area, or major surgical intervention in the targeted area planned within the next 18 months (like Caldwell Luc) (minor interventions like surgical tooth extraction or root tip resections are allowed)
- Surgical tooth extraction in the targeted area less than three months before the SLP
- Maxillary and sinus disorders including: acute sinusitis, chronic sinus pathology, retained root tips, polyps, tumors, and cysts in antral cavity or odontogenic cysts, alveolar scar ablation
- Major occlusal disturbance, like severe bruxism
- Uncontrolled* periodontal disease
- An inadequate interarch distance requiring an oppositional graft
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- Immune system disorders, immunodeficiency or immunosuppression
- Known coagulation disorder
- Uncontrolled* diabetes mellitus
- Severe hyperparathyroidism
- Receiving long-term anti-inflammatory treatment with NSAIDs or corticosteroids
- Chemotherapy current or in the last three months
- Having undergone maxillary radiation therapy
- Known hypersensitivity to aprotinin or to other components of the investigational product
- Abuse of alcohol or drugs or tobacco consumption of more than 5 cigarettes per day at study start
- Non-compliant for future dental hygiene
- Severely compromised physical and psychological health, that in the investigators opinion will affect patient compliance
- Any contra-indications to the use of MBCP, which are defined as osteomyelitis, degenerative bone disease or necrosis of the recipient site
- Concurrently participating in another clinical trial and having received another investigational drug or device within the last 30 days
- Pregnant or lactating, or intending to become pregnant during the study period
- Uncontrolled = not treated or not stabilized after treatment
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Klinik für Mund-, Kiefer- und Gesichtschirurgie des Helios-Klinikums Erfurt
Erfurt, 99089
Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie der Universität Erlangen-Nürnberg
Erlangen, 91054
Universitätsklinikum Schleswig Holstein, Campus Kiel
Kiel, 24105
About this study
Official title: A Prospective Clinical Study to Evaluate the Performance and Safety of the Bone Substitute MBCP-FS in Maxillary Sinus Lift Procedures
The purpose of this study is to evaluate the performance and to monitor the safety of the bone substitute Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS) in Sinus Lift Procedures . This study will be conducted in two parts: part A evaluates safety and performance of MBCP-FS in bone regeneration i.e. the amount of new bone that is formed and its suitability for dental implant placement. Part B is designed to evaluate long-term safety and performance of the product, i.e. whether the newly-formed bone is suitable to retain implants.
- Conditions
- Sinus Implant Reconstruction
- Being tested
- Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS)
- Keywords
- Sinus augmentation, Alloplastic bone substitute, Hydroxyl apatite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS)Device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startSep 2004
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus Implant ReconstructionStudies 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 2/3
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Baxter BioScience Investigator, Principal investigator, Baxter BioScience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163605
- Sponsor's protocol ID
- 570201
- Status last verified
- Nov 2007
- First submitted
- 8 Sep 2005
- Last updated
- 15 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study to Evaluate the Performance and Safety of the Bone Substitute MBCP-FS in Maxillary Sinus Lift Procedures
- ClinicalTrials.gov ID
- NCT00163605
- Acronym / sponsor ID
- 570201
- Conditions
- Sinus Implant Reconstruction
- Keywords
- Sinus augmentation, Alloplastic bone substitute, Hydroxyl apatite
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Study completion
- Nov 2007 (actual)
- First posted
- 14 Sep 2005 (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 this study is to evaluate the performance and to monitor the safety of the bone substitute Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS) in Sinus Lift Procedures . This study will be conducted in two parts: part A evaluates safety and performance of MBCP-FS in bone regeneration i.e. the amount of new bone that is formed and its suitability for dental implant placement. Part B is designed to evaluate long-term safety and performance of the product, i.e. whether the newly-formed bone is suitable to retain implants.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent obtained from the subject prior to participation in the study
- At least 18 years of age
- Partially or totally edentulous with an atrophic posterior maxilla requiring unilateral or bilateral sinus lift before dental implant placement
- In case of bilateral sinus lifts, both sides are operated on the same day.
- Subjects with remaining minimal maxillary bone height between 2 mm and 5 mm at the site with minimal height in the area where implants are planned, and a remaining maxillary bone thickness >= 5 mm in the area where implants are planned
Key exclusion criteria (21 listed)
- Previous or coeval major surgical intervention in the targeted area, or major surgical intervention in the targeted area planned within the next 18 months (like Caldwell Luc) (minor interventions like surgical tooth extraction or root tip resections are allowed)
- Surgical tooth extraction in the targeted area less than three months before the SLP
- Maxillary and sinus disorders including: acute sinusitis, chronic sinus pathology, retained root tips, polyps, tumors, and cysts in antral cavity or odontogenic cysts, alveolar scar ablation
- Major occlusal disturbance, like severe bruxism
- Uncontrolled* periodontal disease
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 |
|---|---|---|
| Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS) | Device | – |
Primary outcome
Not reported in the source record.
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 15 Nov 2007.
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.
Baxter BioScience Investigator principal investigator
Baxter BioScience
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS) in people with Sinus Implant Reconstruction, run by Baxter Healthcare Corporation at 3 sites in Germany.
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 5 inclusion and 21 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 15 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
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 15 Nov 2007.