Initial Fixation of Bisphosphonate-coated Dental Implants
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Pre-integration Failure of Dental Implant
- Sponsor
- Per Aspenberg
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- Vibration frequency ratio
- Last Updated
- 10 years ago
Overview
Brief Summary
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
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).
Investigators
Per Aspenberg
professor
University Hospital, Linkoeping
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Vibration frequency ratio
Time Frame: 4 and 6 weeks
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.
Secondary Outcomes
- Marginal resorption(8 weeks)
- Vibration: area under the curve(2-8 weeks)