Pre-integration Failure of Dental Implant
Conditions
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).
Interventions
DEVICEZoledronate-coated dental implant
Sponsors
Per Aspenberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vibration frequency ratio | 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
| Measure | Time frame | Description |
|---|---|---|
| Marginal resorption | 8 weeks | 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. |
| Vibration: area under the curve | 2-8 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 all weeks will be used. |
Countries
Sweden
Contacts
Primary ContactJahan Abtahi, MD, PhD
Backup ContactPer Aspenberg, MD, PhD
Outcome results
None listed