N/A
N=11
Straumann Bone Ceramic Versus BioOss in Sinus Elevation
Jaw, Edentulous, Partially · Alveolar Bone Loss
Bottom Line
View on ClinicalTrials.gov: NCT00900822 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Histologically Measured Bone to Implant Contact (BIC) — 64.552; 54.904 percentage of total surface
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Straumann Bone Ceramic (Device); BioOss (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Institut Straumann AG
- Primary completion
- Jun 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Histologically Measured Bone to Implant Contact (BIC) |
64.552; 54.904 | — |
| SECONDARY Implant Survival Rate |
96.7; 96.7 | — |
| SECONDARY Implant Success Rate |
93.6; 96.8 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00900822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.