Jaw, Edentulous, Partially, Alveolar Bone Loss
Conditions
Keywords
bone grafting, sinus elevation, sinus augmentation
Brief 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.
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.
Interventions
DEVICEStraumann Bone Ceramic
Granules applied once during surgery
DEVICEBioOss
Granules that are applied once during surgery
Sponsors
Institut Straumann AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 * 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%
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Histologically Measured Bone to Implant Contact (BIC) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survival Rate | 12 months after loading the implant | The percentage of implants remaining in the jaw. |
| Implant Success Rate | 12 months after loading the implant | 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. |
Countries
Sweden
Participant flow
Recruitment details
Recruitment started Oct 2005 and was completed June 2006.
Pre-assignment details
Split-mouth design (test and control in the same patient).
Participants by arm
| Arm | Count |
|---|---|
| Straumann Bone Ceramic Synthetic bone graft material | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Straumann Bone Ceramic |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 65.27 years STANDARD_DEVIATION 9.06 |
| Region of Enrollment Sweden | 11 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 11 | 4 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
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
Time frame: 9 months after implant placement
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Straumann Bone Ceramic | Histologically Measured Bone to Implant Contact (BIC) | 64.552 percentage of total surface | Standard Deviation 9.036 |
| BioOss | Histologically Measured Bone to Implant Contact (BIC) | 54.904 percentage of total surface | Standard Deviation 15.995 |
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.
Time frame: 12 months after loading the implant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Straumann Bone Ceramic | Implant Success Rate | 93.6 percentage of implants |
| BioOss | Implant Success Rate | 96.8 percentage of implants |
Secondary
Implant Survival Rate
The percentage of implants remaining in the jaw.
Time frame: 12 months after loading the implant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Straumann Bone Ceramic | Implant Survival Rate | 96.7 percentage of implants |
| BioOss | Implant Survival Rate | 96.7 percentage of implants |