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16 patients will be included. Each patient receives 2 dental implants. One of them is coated with a drug, zoledronate, to improve fixation. Fixation is measured by vibration resonance frequency analysis at insertion and 2, 4, 6 and 8 weeks after insertion.The 2 implants in each patient are compared. We expect to find an early improvement (higher resonance frequency) in the coated implant.
The zoledronate is linked to the titanium implant surface via a nanolayer of crosslinked fibrinigen. Resonance frequency is measured with standard clinical equipment (Ostell apparatus).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bisphosphonate implant | Active Comparator | Dental implant coated with zoledronate Note: Both arms in each patient (2 implants) |
|
| control | Placebo Comparator | Dental implant without coating Note: Both arms in each patient (2 implants) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronate-coated dental implant | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vibration frequency ratio | Each patients has a study implant and a control implant. Their change vibation frequency from insertion till measurement time point is measured and the ratio between changes for the 2 implants forms the outcome measure. Avarage values for 4 and 6 weeks will be used. | 4 and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Marginal resorption | Radiographic loss of bone at the margin of the implant, measured as difference in mm from the superficial bone contour between insertion and 8 weeks. | 8 weeks |
| Vibration: area under the curve |
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Inclusion Criteria:
Need for dental implant in upper jaw. CTscan showing at least 6 mm bucco-lingual thickness. Generally healthy
Exclusion Criteria:
Drugs or conditions that influence or are thought to influence bone healing, such as bisphosphonates, corticosteroids, other oral pathologies, severe autoimmune diseases, cancer. Osteoporosis is not cause for exclusion.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jahan Abtahi, MD, PhD | Contact | jahan.abtahi@lio.se | ||
| Per Aspenberg, MD, PhD | Contact | per.aspenberg@liu.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Käkcentralen | Recruiting | Linköping | 58185 | Sweden |
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Each patients has a study implant and a control implant. Their change vibation frequency from insertion till measurement time point is measured and the ratio between changes for the 2 implants forms the outcome measure. Avarage values for all weeks will be used.
| 2-8 weeks |
| Tandläkarhuset | Recruiting | Linköping | 58227 | Sweden |
|