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Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

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

An Open, Prospective, Multicenter Investigation to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Extraction Sockets and Healed Ridges - A 5 Year Follow-up

NCT05315414•Dentsply Sirona Implants and Consumables

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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;
+19 more criteria

Locations (5)

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

Key Dates

Start Date

May 3, 2022

Primary Completion Date

March 12, 2025

Completion Date

May 1, 2029

Last Updated

August 28, 2025

Enrollment

138

ACTUAL participants

Conditions

Jaw, Edentulous, Partially

Interventions

PrimeTaper EV implant

DEVICE

Esthetic, Clinical and Radiographic Outcomes of Immediate and Delayed Implant Placement

NCT02814149

Jaw, Edentulous, PartiallyAcquired Absence of Single Tooth

View study

ACTIVE_NOT_RECRUITINGNA

Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants

NCT05883202

Jaw, Edentulous, Partially

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Esthetic, Clinical and Radiographic Outcomes of Immediate and Delayed Implant Placement

Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants

Immediate Loading of Implants in the Partially or Completely Edentulous Jaw

Esthetic and Radiographic Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall

Evaluation of Mandibular Posterior Zirconia Crowns With Different Ti-Base Surface Treatments.

Pain Severity in Flapless Dental Implant Placement Using Laser