K08.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - non smoker - minimum 25 years of age - no pregnancy - ability to understand the study procedures and adhere to them for the whole duration of the study - ability and willingness to agree in written form
Exclusion criteria
Exclusion criteria: - existing or planned pregnancy or lactation period - Participation in another clinical study, inability or unwillingness to sign a written form of consent or other non-fulfillment of beforementioned inclusion criteria - Known or persisting abuse of drugs or alcohol - Medication that influences bone metabolism (e.g. bisphosphonates, corticosteroids) - untreated diabetes mellitus (HbA1c >7) - radiation therapy in the head or neck area, Morbus Crohn, immunosuppressions with major impairment of wound healing - diseases of the oral mucosa at the surgical site e.g. Leukoplakia etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival and success rate of the implants. Success is defined by the following criteria: - PPD = 5 mm without BOP - no suppuration - periimplant bone loss <2mm after 6, 12, 24 and 60 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Documentation of the practicability of the method in terms of achieving primary stability by measuring the insertion torque and the final torque | — |
Countries
Germany
Contacts
Hürzeler/Zuhr Academy GmbH