Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Resto… (NCT05315414) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
United States, Belgium, Germany138 participantsStarted 2022-05-03
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 wou…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Implant survival, i.e. number of implants in place counted clinically, 1 year after permanent restoration.
Timeframe: One year post permanent restoration (anticipated average 3 months after implant placement).