implant stability local skin reactions
Conditions
Interventions
The intervention is surgical placing of a new type of titanium implant to
connect a BCD. 60 patients will participate in the study, of which 40 will
receive the test, wide implant, while the other 2
Sponsors
Oticon Medical AB
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: The subject is/has: 1. 18 years or older; 2. given written informed consent to participate in the study; 3. eligible for the BCD system; 4. eligible for implantation with a BCD implant (bone thickness at implant site at least 4mm).
Exclusion criteria
Exclusion criteria: The subject is/has: 1. age below 18 years; 2. longer abutment (>6mm) required; 3. inability to participate in follow-up; 4. psychiatric disease in the medical history; 5. mental disability; 6. presumed doubt, for any reason, that the patient will be able to show up on all follow ups; 7. disease or treatment known to compromise the bone quality at the implant site: radiotherapy, osteoporosis, diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objectives consider the implant stability, skin reactions and effects of early loading of the BCD processor. Both implant stability and the effects of early loading on the implant stability will be measured by RFA and valued in ISQ. ISQ values can be used to see the evaluation of the stability of the implant during time. Skin reactions will be assessed using the scale developed by Holgers: Grade 0: no irritation; epidermal debris removed if present. Grade 1: slight redness; temporary local treatment. Grade 2: redness and slightly moist tissue, no granulation; local treatment, extra follow up. Grade 3: red and moist, sometimes granulation; surgical revisions is indicated. Grade 4: removal of skin-penetrating implant necessary due to infection. Long-term effects of the new implant and the early loading will be easily conducted from all parameters described, when followed over a course of time. Furthermore there will be subjective outcome measurement using the GBI. | — |
Secondary
| Measure | Time frame |
|---|---|
| When implant stability show the lowest values, the initial mechanical stability is gradually replaced by biological stability. To assess this moment, there will need to be established an average value of all ISQ data. When plotted in a graphic as a function of time, the lowest point in the graph will be the time implant stability is the lowest (and the initial mechanical stability is gradually replaced by biological stability). | — |
Countries
Netherlands
Outcome results
None listed