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

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 areexcluded), and each subject can only receive one implant.

• Deemed by the PI/Subinvestigator as likely to present with an initially stableimplant situation.

• A stable occlusion, i.e. an opposing natural dentition, a crown, animplant-supported fixed or removable prosthesis, a partial removable prosthesis or afull denture.

• An adjacent tooth (root with natural or artificial crown) or an implant-supportedcrown mesially and distally. Exemption: If the planned implant is in the first molarposition, an edentulous space is accepted distally

Exclusion Criteria:

• Not willing to participate in the clinical investigation or not able to understandthe content of the clinical investigation.

• Unlikely to be able to comply with clinical investigation procedures according toPI'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 DentsplySirona.

• Known allergy or hypersensitivity to titanium and/or stainless steel.

• Uncontrolled pathological process in the oral cavity, e.g. untreated rampant cariesand uncontrolled periodontal disease.

• Uncontrolled para-functional habits, e.g. bruxism.

• Current need of any Guided Bone Regeneration (GBR) procedure in the planned implantarea (gap filling at immediate placement and soft tissue grafting are allowed).

• Systemic or local disease or condition that would compromise post-operative healingand/ or osseointegration.

• Immunosuppression, use of corticosteroids, prior or current use of oral orintravenous bisphosphonate, or any other medication such as anti-resorptive therapyor monoclonal antibodies that could compromise post-operative healing and/orosseointegration.

• 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 localrequirements).

• Previous enrolment in the present clinical investigation.

• Involvement in the planning and conduct of the clinical investigation (applies toboth Dentsply Sirona personnel and the clinical investigation site).

• Simultaneous participation in another clinical investigation, or participation in aclinical investigation during the last 6 months that may interfere with the presentclinical 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.