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

Clinical Investigation Title: An Open, Prospective, Multicenter Investigation to Evaluate the Clinical Outcome of OmniTaper EV Implants in Extraction Sockets and Healed Ridges - A 5-year Follow-up

This clinical study, funded by the company Dentsply Sirona, is being carried out to see if the newly developed tooth implant "OmniTaper EV" is safe, effective and functions as intended when replacing a lost or removed tooth. The OmniTaper EV implant is a further development of existing dental implants. It is made of titanium, a metal that is well tolerated by the human body, which has been successfully used in dental implants for more than 40 years. All components used in this study are available on the market, are CE-marked and will be used according to intended use and approved instructions.

The study involves at 11 planned clinic visits including follow-up visits 6 months and annually until 5 years after installation of the permanent crown. after over a period of about five and a half years. The treatment method and healing period may vary depending on the individual case and treatment plan and additional visits may therefore need to be scheduled. The visits and procedures are the same as standard of care and no procedures will be done just for purpose of research.

The study aims to recruit about 137 men and women from six clinics across Europe (Germany, UK and Switzerland) and participants can only receive one study implant each. Participation is entirely voluntary and participants can choose to withdraw from the study at any time, without giving a reason. The decision to decline or withdraw participation will not affect participants future treatment or care

Inclusion Criteria:

• 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 (2nd and 3rd molars are excluded), and each subject can only receive one implant.
• Deemed by the PI/Subinvestigator 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 PI's/Subinvestigator's judgement.

• Unable or unwilling to return for follow-up visits for a period of 5 years.

• Severe non-compliance to CIP as judged by the PI/Subinvestigator and/or Dentsply Sirona.

• 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, prior or current use of oral or intravenous bisphosphonate, 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 /Not applicable for UK).

• 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 (as reported by the subject).
  • 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 personnel 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.