Status:
ACTIVE_NOT_RECRUITING
Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
Lead Sponsor:
Dentsply Sirona Implants and Consumables
Conditions:
Jaw, Edentulous, Partially
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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
- 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
- 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.
Key Trial Info
Start Date :
May 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2029
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT05315414
Start Date
May 3 2022
End Date
May 1 2029
Last Update
August 28 2025
Active Locations (5)
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1
University of Iowa
Iowa City, Iowa, United States, 52242-1010
2
Catholic University of Leuven
Leuven, Belgium, B-3000
3
Dental practice Dr Mischa Krebs
Alzey, Germany, DE-55232
4
Studio Toia
Busto Arsizio, Italy, IT-21052