Multicenter Study Comparing OsseoSpeed TX With OsseoSpeed EV. (NCT01528215) | Clinical Trial Compass
CompletedNot Applicable
Multicenter Study Comparing OsseoSpeed TX With OsseoSpeed EV.
United States, Belgium, Germany120 participantsStarted 2011-11
Plain-language summary
The purpose of this study is to evaluate the outcome of implant OsseoSpeed EV compared to implant OsseoSpeed TX with regards to marginal bone level changes and implant survival rate up to five years after implant loading. The hypothesis is that there will be no clinically relevant differences in marginal bone level alterations one year after functional loading.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Provision of Informed Consent.
✓. 18 -75 years at enrollment.
✓. In need of implant(s) replacing missing tooth/teeth in the maxilla or in the mandible (no edentulous jaws).
✓. History of edentulism in the planned implant area of at least 3 months (at Visit 2).
✓. At least 4 months of healing after last grafting procedure in the planned implant area (at Visit 2).
✓. Deemed by the investigator to be suitable for one stage surgery and be likely to present an initially stable implant situation i.e. have a bone height and bone width suitable for the chosen study implants.
✓. Deemed by the investigator to be suitable for loading after 6-8 weeks.
✓. Deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants i.e. an even distribution of contacts between the teeth in the opposite jaw and the planned permanent crown/bridge.
Exclusion criteria
✕. Unlikely to be able to comply with study procedures, as judged by the investigator.
✕. Uncontrolled pathological processes in the oral cavity.