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 range18 Years – 75 Years
SexALL
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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…
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).