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

Running, not enrolling · Not applicable

Conditions studied: Jaw, Edentulous, Partially

In brief

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.

Key facts

Study ID

NCT05315414

Run by

Dentsply Sirona Implants and Consumables

People needed

138

Starts

2022-05-03

Expected to finish

2029-05-01

Last updated by the study team

2025-08-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• University of Iowa — Iowa City, Iowa, United States
• Catholic University of Leuven — Leuven, Belgium
• Dental practice Dr Mischa Krebs — Alzey, Germany
• Studio Toia — Busto Arsizio, Italy
• Dr.F.L.Guljé, De Mondhoek — Apeldoorn, Netherlands

Full record on ClinicalTrials.gov

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