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

This is an interventional treatment trial for Jaw, Edentulous, Partially Read More

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.