Pre-integration Failure of Dental Implant Clinical Trial
Official title:
Initial Fixation of Bisphosphonate-coated Dental Implants
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.
| Status | Recruiting |
| Enrollment | 16 |
| Est. completion date | January 2017 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Käkcentralen | Linköping | |
| Sweden | Tandläkarhuset | Linköping |
| Lead Sponsor | Collaborator |
|---|---|
| Per Aspenberg |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |