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The aim of the present study is to compare the rate of new bone formation after sinus floor elevation with or without perforation of the cortical sinus floor prior to insertion of augmentation material. Twelve patients requiring bilateral sinus floor elevation will be recruited for a pilot study in split-mouth design. On both sides a lateral window will be prepared and the sinus mucosa will be elevated. After this step, the sides are assigned as test or control side. While the control side is just filled with augmentation material, an additional step is performed for the test side, i.e., prior to inserting the augmentation material, the cortical bone layer of the sinus floor is perforated several times into the trabecular bone layer to improve the blood supply to the grafting material. Thereafter, both sides are left to healing for 4-6 months until implant installation. At timepoint of implant installation, a bone biopsy will be collected to allow histological assessment of the grafted area.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | standard sinus floor elevation |
|
| Test | Experimental | standard sinus floor elevation with additional perforation of the sinus floor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| perforation of the sinus floor | Procedure | perforation of the cortical layer of the sinus floor prior to inserting the augmentation material during sinus floor elevation |
|
| Measure | Description | Time Frame |
|---|---|---|
| New bone formation | histological assessment of new bone formation after sinus floor elevation (%) | 4-6 months after sinus floor elevation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinic of Dentistry, Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
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| no perforation of the sinus floor | Procedure | standard procedure for sinus floor elevation |
|