Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations

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.