Straumann Bone Ceramic Versus BioOss in Sinus Elevation

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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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

Conditions
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Jaw, Edentulous, Partially, Alveolar Bone Loss

Intervention / Treatment
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* Device: Straumann Bone Ceramic
* Device: BioOss


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Straumann Bone Ceramic<br>StraumannBone Ceramic is used as bone grafting material in sinus augmentation procedures | Device: Straumann Bone Ceramic<br>* Granules applied once during surgery<br>|
| Active Comparator: BioOss<br>BioOss is used as a bone grafting material in sinus augmentation procedure | Device: BioOss<br>* Granules that are applied once during surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 12 months after loading the implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone grafting, sinus elevation, sinus augmentation