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NCT05315414
Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
Conditions: Jaw, Edentulous, Partially
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 138
Sponsor: Dentsply Sirona Implants and Consumables
Location: University of Iowa Iowa City Iowa
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.
Source: ClinicalTrials.gov (NCT05315414). StuddyBuddy aggregates publicly available trial information.