Initial Fixation of Bisphosphonate-coated Dental Implants

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Initial Fixation of Bisphosphonate-coated Dental Implants

Conditions
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Pre-integration Failure of Dental Implant

Intervention / Treatment
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* Device: Zoledronate-coated dental implant


Participation Criteria
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Eligibility Criteria
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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.
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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bisphosphonate implant<br>Dental implant coated with zoledronate Note: Both arms in each patient (2 implants) | Device: Zoledronate-coated dental implant<br> <br> |
| Placebo Comparator: control<br>Dental implant without coating Note: Both arms in each patient (2 implants) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |