Status:
COMPLETED
Straumann Bone Ceramic Versus BioOss in Sinus Elevation
Lead Sponsor:
Institut Straumann AG
Conditions:
Jaw, Edentulous, Partially
Alveolar Bone Loss
Eligibility:
All Genders
18-80 years
Phase:
NA
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. T...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00900822
Start Date
November 1 2005
End Date
December 1 2008
Last Update
March 31 2016
Active Locations (1)
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1
Dr Mats Hallman
Gävle, Sweden, 80187