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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Straumann Bone Ceramic | Experimental | StraumannBone Ceramic is used as bone grafting material in sinus augmentation procedures |
|
| BioOss | Active Comparator | BioOss is used as a bone grafting material in sinus augmentation procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Straumann Bone Ceramic | Device | Granules applied once during surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 9 months after implant placement |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survival Rate | The percentage of implants remaining in the jaw. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mats Hallman, DDS, PhD | Clinic for oral maxillofacial surgery, Gävle hospital, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Mats Hallman | Gävle | 80187 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20491816 | Result | 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. | |
| 20162114 |
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Split-mouth design (test and control in the same patient).
Recruitment started Oct 2005 and was completed June 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Straumann BoneCeramic | Synthetic bone graft material |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9 Months Histological Evaluation |
| |||||||||||||
| 12 Months Clinical Evaluation |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Straumann Bone Ceramic | Synthetic bone graft material |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Implant Survival Rate | The percentage of implants remaining in the jaw. | Posted | Oct 2009 | Number | percentage of implants | 12 months after loading the implant |
|
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Straumann Bone Ceramic | Synthetic bone graft material |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Exposure of implant | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinial Trial Manager | Institut Straumann AG | +41 61 965 11 11 | info@straumann.com |
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| ID | Term |
|---|---|
| D007576 | Jaw, Edentulous, Partially |
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
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| BioOss |
| Device |
Granules that are applied once during surgery |
|
| 12 months after loading the implant |
| Lindgren 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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 | This was a split-mouth design. Each patient received both treatments. There was one sample in the Straumann BoneCeramic group that could not be analyzed. | Posted | Mean | Standard Deviation | percentage of total surface | 9 months after implant placement |
|
|
|
| Secondary | 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. | Posted | Number | percentage of implants | 12 months after loading the implant |
|
|
|
| 0 |
| 11 |
| 3 |
| 11 |
| EG001 | BioOss | Xenograft bone graft material | 0 | 11 | 4 | 11 |
| Implant infection | General disorders | Non-systematic Assessment |
|
| Mobile implant | General disorders | Non-systematic Assessment |
|
| Fenestration of implant | General disorders | Non-systematic Assessment |
|
| Sinusitis | General disorders | Non-systematic Assessment |
|
| Contact between cover screw and prosthesis | General disorders | Non-systematic Assessment |
|
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| D009066 |
| Mouth, Edentulous |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D055093 | Periodontal Atrophy |
| D010510 | Periodontal Diseases |