multicenter study to evaluate the clinical outcome of primetaper ev implant in single tooth restorations

Conditions: Jaw, Edentulous, Partially

Summary: the purpose of this study is to evaluate the clinical outcome of implant survival of the primetaper ev implant in single tooth restorations 1 year after permanent restoration.


Eligibility criteria:
inclusion criteria: * adult aged 18-75 years. * willing and able to sign and date the informed consent form. * in need of an implant in position 16 to 26 or 36 to 46, and each subject can only receive one implant. * deemed by the investigator as likely to present with an initially stable implant situation. * a stable occlusion, i.e. an opposing natural dentition, a crown, an implant-supported fixed or removable prosthesis, a partial removable prosthesis or a full denture. * an adjacent tooth (root with natural or artificial crown) or an implant-supported crown mesially and distally. exemption: if the planned implant is in the first molar position, an edentulous space is accepted distally exclusion criteria: * not willing to participate in the clinical investigation or not able to understand the content of the clinical investigation. * unlikely to be able to comply with clinical investigation procedures according to investigator's judgement. * unable or unwilling to return for follow-up visits for a period of 5 years. * known allergy or hypersensitivity to titanium and/or stainless steel. * uncontrolled pathological process in the oral cavity, e.g. untreated rampant caries and uncontrolled periodontal disease. * uncontrolled para-functional habits, e.g. bruxism. * current need of any guided bone regeneration (gbr) procedure in the planned implant area (gap filling at immediate placement and soft tissue grafting are allowed). * systemic or local disease or condition that would compromise post-operative healing and/ or osseointegration. * immunosuppression, use of corticosteroids, per-os or intravenous bisphosphonate use, or any other medication such as anti-resorptive therapy or monoclonal antibodies that could compromise post-operative healing and/or osseointegration. * any other condition that would make the subject unsuitable for participation, including but not limited to; * history of radiation therapy in the head and neck region. * history of chemotherapy within 5 years prior to surgery. * present alcohol and/or drug abuse. * ongoing psychiatric illness. * current smoking/use of tobacco, including e-cigarettes. * any ongoing disease that would make the subject unsuitable for participation, including but not limited to; * recent myocardial infarction (\< 3 months\*). * recent cerebrovascular accident (\< 3 months\*). * recent cardiac-valvular prosthesis placement (\< 3 months\*). * hemorrhagic diathesis. * severe liver dysfunction. * known or suspected current malignancy. * uncontrolled diabetes mellitus. * florid infection. * pregnant or breastfeeding females. (pregnancy tests will be performed as per local requirements). * previous enrolment in the present clinical investigation. * involvement in the planning and conduct of the clinical investigation (applies to both dentsply sirona staff and the clinical investigation site). * simultaneous participation in another clinical investigation, or participation in a clinical investigation during the last 6 months that may interfere with the present clinical investigation. * \< 3 months is a strict exclusion criterion. after 3 month it is up to the investigator to judge whether the subject is considered suitable for participation or not.